United States GlobalHealth Policies:Gaps and Opportunities for Improvements

United States Global Health Policies: Gaps and Opportunities for Improvements

United States Global Health Policies: Gaps and Opportunities for Improvements

Acknowledgements The Global Health Council gratefully acknowledges the support of the Bill & Melinda Gates Foundation. This report would not have been possible without its generous contribution.

The Council would like to thank Peg Willingham who helped to shed light on many issues concerning tuberculosis research. In addition, the authors would like to acknowledge the contributions of the Global Health Council’s staff, in particular: Neda Dowlatshahi, Rachel Hampton, Kathryn Rosecrans, Duncan Rollason and Kimberly Sutton. We value the input and the ideas of all those who took part in this project and look forward to working with you in the future.

The authors of this report are: yy Alexandra Fedorova, Research Associate, Global Health Council yy Dina Mikdadi, Research and Analysis Intern, Global Health Council yy Smita Baruah, Director of Policy and Government Relations, Global Health Council yy Susan Higman, Director of Research and Analysis, Global Health Council The report was reviewed by Jeffrey L. Sturchio, President and CEO of the Global Health Council.

Global Health Council (GHC) is a 501(c)(3) nonprofit membership organization that is funded through membership dues and grants from foundations, corporations , and private individuals. The opinions expressed herein do not necessarily reflect the views of GHC. This report is provided as a resource for GHC’s members, journalists, educators, and other stakeholders in US global health policies to help them better understand the US global health issues and policy choices.

For further information about GHC or this report, please call our Washington office at 202-833-5900 or e-mail us at research@globalhealth.org Visit our website, www.globalhealth.org Copyright © December 2010 by the Global Health Council All rights reserved.

Printed in the United States of America.

United States Global Health Policies: Gaps and Opportunities for Improvement United States global health policies: Gaps and opportunities for improvement 1 Introduction 1 U.S. global HIV/AIDS policy 4 The President’s Emergency Plan for AIDS Relief (PEPFAR) 5 PEPFAR I versus PEPFAR II 5 The balance between prevention and treatment 7 Funding instability 8 HIV/AIDS prevention 12 Assessment of PEPFAR prevention methods 14 Counseling and testing 29 HIV/AIDS treatment 30 Antiretroviral adherence and patient retention 31 New government partnerships 32 Transparency in PEPFAR policies and programs 33 HIV/AIDS program monitoring and evaluation 35 Conclusion 35 U.S. global tuberculosis policy 37 U.S. response to TB 38 TB funding 40 HIV/AIDS and TB co-infection 42 Diagnostics, prevention and treatment 46 Slow progress in implementation of the Stop TB strategy 48 Conclusion 48 U.S. global malaria policy 50 U.S. response to malaria 51 U.S. funding for malaria 52 U.S. goals and targets for malaria 54 WHO guidelines 55 Challenges 55 PMI technical strategy for prevention 56 PMI technical strategy for diagnosis and treatment 58 PMI results: assessing impact 59 Conclusion 60 U.S. maternal, newborn, child and reproductive health policies 62 Funding for MNCRH 65 Global action 67 U.S. MNCH activities 68 U.S. family planning and reproductive health policy 71 Conclusion 75 Key findings and recommendations 76 Conclusion 81 Abbreviations 91

United States Global Health Policies Gaps and Opportunities for Improvement Introduction

T

he United States is active in many areas of global health, directing financial, technical and programming assistance to developing countries that will improve the health and wellbeing of millions of people through increased access to live-saving goods and services. Many positive outcomes have resulted from the assistance provided by U.S. programs, including the

President’s Emergency Plan for AIDS Relief (PEPFAR) and the President’s Malaria Initiative (PMI), as well as programs to address tuberculosis (TB), maternal and child health, and reproductive health.

In May 2009, the United States introduced the Global Health Initiative (GHI), the first comprehensive approach to global health that aims to build upon the successes of PEPFAR and PMI.1 The GHI supports the goals outlined for PEPFAR and PMI, and aims to link these efforts with other global health programs. The United States proposes to reach goals outlined in PEPFAR and PMI through increased health systems strengthening, and increased strategic coordination and integration with other global health programs.

In addition to the positive outcomes, there have been shortfalls—when policies and programs have failed to live up to their goals—and times when policy and practice were not guided by the evidence base. This report undertakes a preliminary comparison of policy, practice and evidence to demonstrate what U.S. global health policy could do better to prevent and treat infections, address the health needs of pregnant women and children, and promote health and well-being. These gaps provide the basis for recommendations for policies and practices that more accurately reflect the best available evidence on successful programming. One challenge is that both PEPFAR reauthorization and GHI are relatively recent, making policy impact difficult to assess comprehensively at this time. As the GHI has not yet finalized its implementation guidelines and has not yet been fully tested on the ground, the following analysis is based on five-year strategies for AIDS, TB and malaria, and on policy/operational guidance as available.

In the first section, the report profiles HIV/AIDS efforts, mainly through PEPFAR, which was established in 2003. PEPFAR represents an unparalleled national commitment to global health issues.

PEPFAR has sustained lives by providing treatment to millions of people infected with HIV/AIDS; many of these people would not have received treatment otherwise. In addition, PEPFAR has provided prevention services and contributed to health systems strengthening and other health programming.

PEPFAR reauthorization has brought positive changes, including modification of provisions related to the funding and content of prevention efforts.

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 1

However, PEPFAR has fallen short in reaching out to populations most in need and using an evidencebased approach to HIV prevention efforts. PEPFAR efforts to alleviate stigma and discrimination against HIV-positive people have also lagged, as has promotion of condom use. The initial focus on abstinence-oriented activities hampered the prevention efforts of many organizations, as has PEPFAR’s retention of the “prostitution pledge” and refusal to fund safe needle exchanges. These policies also have further stigmatized many marginalized groups, who are at high risk of HIV infection and transmission.

The second section of the report focuses on tuberculosis control efforts, which have suffered from limited funding and attention for many years. TB programs were authorized along with PEPFAR in the first legislation passed in 2003 and then again in 2008. The Directly Observed Treatment, Short Course (DOTS) approach has been effective in promoting treatment of TB, yet most of the medications and the BCG vaccine were developed more than 40 years ago. The lack of policy on expanding TB testing, promoting diagnosis and treatment, monitoring and evaluation, and developing new treatments is of concern, as multi- and extensively drug resistant strains of TB are increasing in many parts of the world. Research on new products and program evaluation/operations research are critical to understanding which interventions are optimal, particularly given the rise in resistant strains and co-infection with HIV. The third section of the report describes malaria control efforts through the President’s Malaria Initiative (PMI), which was also authorized in the PEPFAR process. Through PMI, the U.S. has provided treatment for and saved the lives of millions of children and adults infected with malaria. Malaria has received some attention in recent years, though there is a need for more progress in several areas. PMI was initiated in a few countries and then expanded; these latter program recipients do not have substantial process or outcomes data available to assess. The relative lack of data on malaria—from an accurate count of number of diagnosed cases to the proper use of insecticide-treated bednets and anti-malarial drugs—presents a challenge to assessment efforts.

The fourth section discusses U.S. efforts in maternal, newborn and child health (MNCH) policies, which received limited funding between 2000 and 2008. Despite an increase in the requested MNCH funding in FY 2010 and FY 2011, the lack of integration of programs is an area of major concern.

Family planning and reproductive health (FP/RH) policies also have been stymied by political and ideological positioning that has made progress difficult. Integrating MCH and FP/RH services, and expanding to include HIV/AIDS and malaria services, remains a challenge in both policy and programming.

The Obama Administration has continued some policies already in place, but is also changing the focus of global health. For example, PEPFAR continues to be the largest U.S. global health program, but it needs to integrate into the newly established GHI. The GHI focus on a women- and girlcentered approach may be helpful in facilitating cooperation between areas such as maternal health and HIV/AIDS, tuberculosis and malaria prevention. Major gaps between policy, practice and research remain, including:

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Less than optimal monitoring and evaluation of programs and policies, Retention of the policies that discriminate against and stigmatize marginalized and vulnerable populations, Funding levels that are inadequate to meet global needs, and The need for new diagnostic, prevention and treatment tools to address current and future health challenges.

Yet there is an opportunity, with PEPFAR, GHI and other U.S. global health efforts to build upon the success of recent years and achieve better health for millions of people living in developing countries. The goal of this report is to highlight those areas where improvements can be carried out, which will increase the enduring impact of the investments made in global health on behalf of the American people.

Key Findings To address the gaps in U.S. global health policies and ensure necessary improvements, a cohesive strategy for action is needed to unify the efforts of global health stakeholders and to achieve universal access to diagnostic, prevention and treatment services.

These policies should reflect the disease burden of each country and address health systems strengthening.

Through the GHI, country ownership of programs and country-led plans should continue to be supported and should hold national governments accountable for implementing policies and programs.

If expected improvements and success are to be achieved, funding increases must be sustained and in many areas, such as TB and prevention programs for the most-at-risk populations, must be increased.

Last but not least, international stakeholders need to work together to establish effective partnerships and greater harmonization of programmatic and funding efforts; this will facilitate development of holistic and integrated strategies, systems and interventions The U.S. government has made progress in many of these areas. The introduction of GHI aims to bring together global health programs and to achieve greater coordination and effectiveness. This report notes these successes, but also points to gaps in the U.S. global health policies that remain, highlighting areas in which additional work is needed.

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U.S. Global HIV/AIDS Policy

O

ver the past 20 years, nearly 25 million people have died from AIDS.2, 3 HIV/AIDS causes debilitating illness

and premature death among people in their prime years of life and has devastated families and communities. Further, HIV/AIDS has complicated efforts to fight poverty, improve health and promote development by:4 Diminishing a person’s ability to provide for his or her family. At the same time, health care costs related to HIV/AIDS consume household incomes. The combined effect of reduced income and increased costs impoverishes individuals and households.

Deepening socioeconomic and gender disparities. Women are at high risk of infection and have few options for providing for their families. Children affected by HIV/AIDS, due to their own infection or parental illness or death, are less likely to receive an education, as they leave school to care for ailing parents and younger siblings.

Straining the resources of communities, including hospitals, social services, schools and businesses.

In addition to overwhelming health care facilities, health care workers, teachers, and business and government leaders have been lost to HIV/AIDS. The impact of diminished productivity is felt on a national scale.

Through unprecedented global attention and intervention efforts, the rate of new HIV infections has slowed and incidence rates have leveled off globally. Fifty-six countries are reporting stable or declining incidence rates of HIV. In 33 countries, HIV incidence fell by more than 25 percent between 2001 and 2009. Despite the progress seen in some countries and regions, the total number of people living with HIV continues to rise.2, 5, 6, 3 In 2009, globally, 1.8 million people died of AIDS, 33.3 million were living with HIV and 2.6 million people were newly infected with the virus.

HIV infections and AIDS deaths are unevenly distributed geographically and the nature of the epidemics vary by region. Epidemics are abating in some countries and growing in others. More than 90 percent of people with HIV live in the developing world.

Recognition that everyone is susceptible to the virus, which does not discriminate by age, race, gender, ethnicity, sexual orientation, or socioeconomic status, is growing. However, certain groups are at particular risk of HIV, including men who have sex with men (MSM), injection drug users (IDUs) and commercial sex workers (CSWs).

The impact of HIV/AIDS on women and girls has been particularly devastating. Women and girls now comprise 50 percent of those aged 15 and older living with HIV. AIDS is also the leading cause of death for women of reproductive age.

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The impact of HIV/AIDS on children and young people is an ongoing problem. In 2009, 400,000 children under age 15 were infected with HIV and 270,000 died of AIDS. In addition, about 15 million children have lost one or both parents to the disease.

Effective prevention and treatment interventions exist, as do research efforts to develop new approaches, medications and vaccines. The sixth Millennium Development Goal (MDG) focuses on reversing the spread of HIV/AIDS by 2015.

The President’s Emergency Plan for AIDS Relief (PEPFAR) In 2003, the United States Congress approved and President George W. Bush signed into law The United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act, which formally established the President’s Emergency Plan for AIDS Relief initiative (PEPFAR; in this report: PEPFAR I).7 The Act recommended an allocation of up to US$15 billion to be spent on HIV/AIDS, tuberculosis and malaria over a 5-year period, and provided the legal and policy framework for these expenditures.

In July 2008, President Bush signed into law The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008, thereby extending the PEPFAR initiative for another five years (in this report: PEPFAR II).8 This revised legislation recommends that the U.S. spend up to US$48 billion between 2009 and 2013 to address these three diseases (US$39 billion for HIV/AIDS, US$4 billion for tuberculosis and US$5 billion for malaria).

PEPFAR is one of the largest international health-assistance programs in history. Since its inception it has been applauded as groundbreaking and has served millions of people. As of 2009, through its partnerships in more than 30 countries, PEPFAR was directly supporting antiretroviral treatment for 2.4 million men, women and children.9 This is an enormous achievement, especially considering that in 2001 only 100,000 people living with HIV in the developing world had access to antiretroviral drugs.10 PEPFAR has collaborated with national AIDS-control programs and worked with host governments to ensure that donor funding and multisectoral planning complemented national AIDS-control strategies. PEPFAR funding has supported HIV treatment services beyond referral hospitals, e.g., at district hospitals and primary health care centers, where most people receive care and where HIV services are integrated into primary care services. Funding from PEPFAR has contributed to enhanced support for pharmacies and laboratories, and has spurred substantial growth of community-based patient-support programs—services that may benefit broad populations of patients. Thus, PEPFAR has numerous achievements, yet there are still challenges in accomplishing its mandate.11

PEPFAR I versus PEPFAR II In 2006, the Government Accountability Office released a report entitled, Spending Requirement Presents Challenges for Allocating Prevention Funding under the President’s Emergency Plan for AIDS Relief.12 This report presented key findings on the progress of PEPFAR I and proposed recommendations to improve its provisions, including: United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 5

Emphasize HIV prevention to a greater extent; Improve data collection on HIV/AIDS prevalence and on populations at risk; Increase attention to address factors that heighten the vulnerability of women and girls to HIV infection; Emphasize strengthening processes that harmonize and align donor and country plans, and coordinate with national AIDS agencies; Transition from using brand name drugs to generic medication; Eliminate budgetary spending requirements on prevention, treatment and care to increase programming flexibility on the ground, particularly related to the abstinence-untilmarriage requirement; Strengthen and expand country capacity to provide services; and Enhance knowledge about which interventions are most effective in countering the pandemic, i.e., learning from experience and program evaluations.

The reauthorization act of 2008 introduced several important changes to PEPFAR I:8 The 33 percent of funds for abstinence-until-marriage directive was revised—it is now recommended that 50 percent of prevention funds should be allocated to abstinence, partner reduction and behavior change programming; A specific target was added for training health care workers, in addition to specific requirements for health systems; Greater emphasis was placed on monitoring and evaluation, and on operations research; The travel ban on HIV-positive persons entering the U.S. was removed; and Greater emphasis was placed on women and girls, and gender-related vulnerabilities to HIV infection (with a requirement that global HIV/AIDS prevention strategies seek to reduce factors that lead to gender disparities in HIV/AIDS).

PEPFAR II provisions recognized the changing nature of the pandemic by signaling the initiative’s evolution from an “emergency response” to a “post-emergency” plan by: Creating country partnership frameworks that increase the host government’s role in fighting the pandemic; Allocating more funds to the health ministries of the host countries for health systems strengthening; and Expanding the country list; moving away from an emphasis on focus countries.

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PEPFAR funding 2005–20109

The balance between prevention and treatment PEPFAR I funds were allocated according to the following guidelines:7 55 percent for treatment of individuals with HIV/AIDS; 15 percent for palliative care of individuals with HIV/AIDS; 20 percent for HIV/AIDS prevention (of which 33 percent was to be spent on abstinenceuntil-marriage programs); and 10 percent for helping HIV/AIDS orphans and vulnerable children.

The Institute of Medicine report, PEPFAR Implementation: Progress and Promise, found that budget allocations setting percentage restrictions on spending for prevention (and subsets of prevention activities), treatment and care have adversely affected implementation of the U.S. Global AIDS Initiative.13 In addition, the report suggested that PEPFAR I provisions have inhibited comprehensive, integrated, evidence-based approaches and, thus, have been counterproductive.

PEPFAR I was criticized widely because 33 percent of its prevention budget was allocated for abstinence-until-marriage programs.14 Many experts argued that this restriction did not provide enough funds for effective prevention programs, such as education about HIV/AIDS, greater condom distribution or community efforts to increase knowledge regarding how to prevent HIV infection.13 It also limited the ability of program managers to expand prevention interventions to the most at-risk populations, such as injection drug users.

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In PEPFAR II,with regard to prevention funding, at least half of prevention funds should still be allocated to support activities promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction.

In reaction to these findings and to promote prevention, the Lantos-Hyde Act called for PEPFAR II to intensify efforts to prevent HIV transmission.8 PEPFAR II provisions lessen the stringent budgetary distribution requirements for prevention, treatment and care articulated in the PEPFAR I legislation. Partnership frameworks, established in the PEPFAR II initiative, are designed to foster flexibility and guidance as to the use of HIV funds and overall program development, based on country needs. These frameworks are five-year plans negotiated between the U.S. and recipient countries.

In PEPFAR II, funds are allocated in the following proportions to address prevention, treatment and care, and assistance for orphans and vulnerable children:8

At least 50 percent for treatment and care, such as ARV distribution, nutritional support for people on ARVs and treatment of opportunistic infections; 10 percent for helping HIV/AIDS orphans and vulnerable children; and The remaining portion for HIV/AIDS prevention.

With regard to prevention funding, at least half of prevention funds should still be allocated to support activities promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction. Should less than 50 percent of prevention funds be allocated for these strategies, a justification is required in many cases, though there is a list of exceptions that require no justification.

The legislation lists these exceptions as follows: Programs and activities that implement or purchase new prevention technologies or modalities, such as medical male circumcision, public education about risks to acquire HIV infection from blood exposures, promoting universal precautions, investigating suspected nosocomial infections, pre-exposure pharmaceutical prophylaxis to prevent transmission of HIV, or microbicides and programs and activities that provide counseling and testing for HIV or prevent mother-to-child prevention of HIV.8

Funding instability The 2008 reauthorization act outlined US$48 billion in funding for PEPFAR over the period of FY 2009 to FY 2013. Under President Obama’s Global Health Initiative (GHI), launched in 2009, the funding period stretched from five years to six years and the budget increased to US$63 billion.

President Obama pledged to increase total HIV/AIDS, TB and malaria funding to US$51 billion by 2013. This figure includes an increase of US$1 billion of additional funds each year; the increase for FY 2010 is US$366 million, rather than the promised US$1 billion. The remaining US$12 billion is slated for other global health issues.15 The GHI seeks to develop a comprehensive U.S. global health strategy, building on disease-specific initiatives.

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PEPFAR allocations, excluding malaria, for FY 2004—FY 2011 (US$ in millions)9TOTAL** Enacted 2004

2005

2006

2007

2008

2009

2010

2011*

Total**

1,643

2,263

2,654

3,669

5,028

5,462

5,542

5,740

26,291

Global Fund

547

347

545

724

840

1,000

1,050

1,000

5,053

Bilateral TB programs

87

94

91

95

163

177

246

251

953

2,277

2,705

3,290

4,518

6,031

6,638

6,838

6,991

32,297

Bilateral HIV/AIDS programs

Total PEPFAR

* Requested ** Includes enacted funding for FY 2004 – FY 2010

Sustainability and balance with other global health programs The funding framework for PEPFAR is the first of its kind. It commits billions of dollars to fight the disease, yet it also commits to fund the antiretroviral supply “indefinitely”. While many governments and organizations supporting HIV/AIDS patients overseas have pledged commitments, the United States still supplies approximately 58 percent of global HIV/AIDS assistance.16 With the combination of escalating treatment costs and addressing relatively neglected prevention measures, HIV/AIDS funding mechanisms may overwhelm or displace U.S. spending on other global health needs.17 In fact, one estimate is that HIV/AIDS spending may consume half of the U.S. foreign assistance budget by 2016.

With the Obama Administration’s introduction of GHI, which takes a more holistic and comprehensive approach to address global health, PEPFAR and the President’s Malaria Initiative are combined under a broader global health policy framework.18 This framework calls for increased integration and coordination among programs, focus on health systems strengthening and a women-centered approach. The other objective for the Global Health Initiative is to balance funding of HIV/AIDS with funding of other global health programs. In addition to health systems strengthening, GHI identifies other priority areas and encompasses an expansive agenda of global

With the combination of

escalating treatment costs and addressing relatively neglected prevention measures, HIV/AIDS funding mechanisms may overwhelm or displace U.S. spending on other global health needs.17

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health issues: tuberculosis, HIV/AIDS, malaria, maternal health, child health, family planning and reproductive health, nutrition and neglected tropical diseases.19, 20

Between 1998 and 2008, U.S. spending on maternal, child and reproductive health remained stagnant, while funding for PEPFAR continued to increase. With the world falling behind on reaching the Millennium Development Goal (MDG) targets for reducing maternal and child mortality, maternal, child and family planning programs have recently received increased attention and resources in the U.S. global health budget.21 This comprehensive global health approach coupled with an economic crisis has led to a new focus on “sustainability� and building country capacity to Between 1998 and respond to national HIV/AIDS needs.22 The chronic nature of HIV/AIDS requires that health maintenance 2008, U.S. spending structures, partnership frameworks with host countries and a focus on strengthening the capacity of host on maternal, child and governments become integral components of future PEPFAR activities. Thus, the initiative is becoming less reproductive health focused on the emergency response needed for shortterm epidemics or acute infections and more focused on remained stagnant, a chronic disease model that emphasizes sustainability while funding for PEPFAR and long-term programming.

In 2006, the PEPFAR initiative supplied 60-80 percent of HIV/AIDS resources in its 15 focus countries: 10 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

continued to increase.

e.g., 62 percent in Zambia, 73 percent in Uganda and 78 percent in Mozambique. Despite increases in PEPFAR funding over the years, host government funding towards HIV/AIDS has been stagnant, e.g., 2 percent in Mozambique and 5 percent in Uganda.23 Under the current model, the financing of HIV/AIDS programs falls largely on external donors rather than host country government financing.

In recent years, however, HIV/AIDS financing has reached a critical stage. Since PEPFAR II was signed into law, the world entered a substantial economic downturn; in particular, the U.S. economic situation is cause for concern. A new report noted that for the first time since 2007, donor contributions to global HIV/AIDS between 2008 and 2009 were flat.16 Moreover, the report found that, in some cases, donor funding levels decreased between 2008 and 2009.

Stagnant funding leads to lack of antiretroviral (ARV) access For most of the countries receiving PEPFAR funds, U.S. resources have flattened over the past two years. Four countries—Malawi, the Democratic Republic of Congo, Lesotho, Cote d’Ivoire—have experienced a significant drop in funding, though it is unclear why these countries received fewer resources. Yet, this drop contrasts with PEPFAR’s commitment to “indefinite funding” for ARVs. Shortfalls in PEPFAR II funding have forced some clinics to stop enrolling new patients in antiretroviral treatment. In Uganda, Dr. Peter Mugyenyi, Executive Director of the Joint Clinical Research Center noted, “After urging people to get tested and to get care, we now have to tell them that treatment is not available.”24 The shortage of both ARVs and clinics able to offer treatment to those eligible for medication may lead to drug sharing between those currently on an ARV regimen and family members or others who are unable to access ARVs. This practice may contribute to the development of drug resistant HIV strains and rising mortality rates.24 International AIDS activists are concerned that such shortfalls in funding might have severe health consequences, including a significant reduction in the number of people receiving HIV/AIDS treatment.25 PEPFAR has, however, changed its policy in Uganda to reverse these trends. In an update on PEFAR programs in Uganda, the U.S. Global AIDS Coordinator Ambassador Eric Goosby stated that, to address the immediate needs, PEPFAR will provide an immediate infusion of antiretroviral drugs to allow partners to refill buffer stocks, avoid stockouts and continue expansion of treatment services.26 Furthermore, to bridge this challenging period, PEPFAR Shortfalls in PEPFAR II will also provide increased short- and medium-term funding have forced some financial assistance. Shortfalls in funding cannot, however, be fixed with short–term initiatives only clinics to stop enrolling and Ambassador Goosby added that to meet the need, Uganda’s national government must resume the central new patients in antirole in leading the national response on health in general, and on HIV/AIDS in particular. retroviral treatment.

Exacerbating the problem of stagnant funding, WHO recently amended its recommendations regarding the United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 11

time to initiate ARV treatment. For many years, WHO advised starting ARV therapy when the CD4+ T-lymphocyte count dropped below 200 cells per cubic millimeter of blood; the new target is a CD4+ T-lymphocyte count below 350.27 This new directive will increase the number of people eligible for ARV treatment, causing more tension around how to provide treatment services.

HIV/AIDS prevention Compared to PEPFAR I, PEPFAR II provisions support a more comprehensive set of prevention activities, including: Preventing mother-to-child transmission, Ensuring safe blood supply, Promoting safe injection practices and handling infected materials, Reducing the risks for injection drug users, Counseling and testing those at risk of infection, Abstaining from sex until marriage, Limiting number of partners, Promoting condom use, and Circumcising males.

The debate on prevention vs. treatment has been raging for many years—prior to PEPFAR’s introduction in 2003—though it has intensified in recent years. The Lazarus Effect (showing men and women with AIDS on the brink of death “resurrected” to life following a course of antiretrovirals) was a powerful image that resonated through the media and influenced public opinion.28 The striking imagery of persons in desperate need of treatment or wasting away for lack of treatment is an easily recognized message.

Promoting prevention has been a challenge, particularly because HIV/AIDS was initially, and in some areas still is, associated with high-risk, highly stigmatized populations, such as men who have sex with men, injection drug users and commercial sex workers and their clients.29 Prevention requires changes in behaviors and practices, which are difficult to initiate and maintain. Results from prevention studies may be indirect or difficult to convey—it is harder to assess infections that did not occur than to quantify treatment effects. In addition, the discomfort in discussing sexual practices (e.g., multiple partners) and the labeling of behavior or lifestyle choices (e.g., injection drug use) made prevention stories less compelling.

Many experts, including the Institute of Medicine, agree that the next phase of PEPFAR should include a greater focus on prevention to reverse the number of HIV infections.13 Treatment is not a stand-alone solution. For every one person in treatment, two become newly infected.3 Prevention must go hand in hand with treatment efforts for either to be effective.30 12 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Many experts, including Diagnosing and treating sexually transmitted infections (STIs) and other infections such as TB are essential in the prevention of HIV.2 Of the 9.27 million incident TB cases in 2007, an estimated 1.37 million cases (15 percent) were also HIV-positive.31 In 2009, Ambassador Goosby cited the importance of prevention as an essential component of PEPFAR II and a required element, along with treatment, to end the pandemic. In the absence of an HIV vaccine or cure and without greater emphasis on prevention, there will be an ever-growing number of people requiring treatment.32

the Institute of Medicine, agree that the next phase of PEPFAR should include a greater focus on prevention to reverse the number of HIV infections.13

Globally, sexual transmission remains the primary driver of the epidemic, as the vast majority of cases are transmitted through heterosexual sex.2 Thus, in addition to the aforementioned at-risk populations, prevention strategies that address the needs of sero-discordant couples and the effects of socio-cultural practices, gender inequity, economic dependency of and violence against women, and discrimination and stigma directed toward vulnerable populations are essential. Researchers and program implementers continue to identify evidence-based and cost-effective behavioral, structural and biomedical interventions. Community-based participation in program development and assessment is crucial to ensuring acceptance of interventions.32

Key points of prevention as outlined in PEPFAR’s five-year strategy33 In the short-term, PEPFAR’s prevention programs will support country efforts to map and document current and emerging prevention needs.

PEPFAR-funded programs will focus on scaling up high-impact, evidence-based approaches that combine prevention and treatment services.

Mutually reinforcing prevention interventions need to target and address the needs of subpopulations in which new infections are concentrated.

Prevention strategies that address the needs of sero-discordant couples and the effects of socio-cultural practices, gender inequity, economic dependency of and violence against women, and discrimination and stigma directed toward vulnerable populations are essential.

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PEPFAR funds will support and evaluate promising and innovative practices to determine program effectiveness and impact at both the country and global levels.

PEPFAR provisions will maximize effects in all areas, particularly in reaching partners and families of people living with HIV/AIDS (PLWHA), by linking treatment and care programs to prevention messaging.

Prevention activities will address and evaluate structural factors, such as economic, social, legal and cultural conditions that contribute to increased risk of HIV infection.

Prevention efforts will contribute to the global evidence base around prevention.

PEPFAR-funded programs will utilize prevention of mother-to-child transmission (PMTCT) as a mechanism to support expanded access to care and related services for pregnant women.

The PEPFAR Operational Plan defines each component of the prevention package. This package includes prevention of mother-to-child transmission, prevention of sexually based transmission, biomedical safety and intervention (i.e., blood and injection safety, injection and non-injection drug use, and male circumcision), and HIV voluntary counseling and testing (HVCT).34 Specific activities to prevent sexual transmission include training and services to promote abstinence (such as delay of sexual activity or secondary abstinence), fidelity and partner reduction, and related interventions that use social and community norms to reduce risk. Other activities supported by the PEPFAR initiative are aimed at preventing HIV transmission, such as the purchase of condoms and promotion of their correct and consistent use. Management and prevention of sexually transmitted infections (STI’s) are also components of HIV prevention activities. Messages and programs to reduce high-risk behaviors in key populations—for example, prevention services for alcohol users, youth, MSM, mobile populations (e.g., migrant workers, truck drivers, police officers and members of military), and persons who exchange sex for money or other goods—also are highlighted in PEPFAR II.34 Of particular concern are people with multiple or concurrent sex partners, including persons engaged in commercial sex work and/or transactional sexual partnerships.

Assessment of PEPFAR prevention methods Although PEPFAR funding has increased over time, the Africa region has always been the primary recipient of assistance. PEPFAR I focused on supporting efforts on 15 countries (Botswana, Cote d’Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam, and Zambia). PEPFAR II provisions have a broader reach and funds are now distributed in Asia, Eurasia and the Western Hemisphere.

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Regional funding for prevention, 2009 (USD in millions)9

Prevention of mother-to-child transmission (PMTCT) Mother-to-child transmission can occur during pregnancy, labor and delivery, or breastfeeding; preventing such transmission is an effective tool to protect infants born to HIV-positive mothers.35 In addition, the WHO notes that “HIV testing and counseling for pregnant women in the context of preventing mother-to-child transmission is the main gateway to providing HIV prevention, treatment, care and support services to women and children in resource-limited settings.”36 PMTCT has been a major focus of PEPFAR’s prevention efforts; from 2004 to 2008, the Office of the Global AIDS Coordinator reported that it was able to reach an increasing percentage of pregnant women.34 The goal of PEPFAR II for the next four years is to ensure 80 percent coverage of testing for pregnant women at the national level and provide treatment to 85 percent of pregnant women found to be infected. Also in line with the Global Health Initiative (GHI), PEPFAR-funded programs see PMTCT as an opportunity to support and expand access to antenatal care.34 The goal of providing treatment to HIV-positive pregnant women was articulated in PEPFAR I (i.e., reducing the proportion of infants infected by HIV by 20 percent by 2005 and by 50 percent by 2010).

In 2008, only 21 percent of pregnant women received an HIV test—though this was an increase of 15 percent over the year before—and 45 percent of women testing positive actually received antiretroviral therapy.37 Though progress has been made in some countries, there is work to be done in counUnited States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 15

In 2008, only 21 percent tries where HIV prevalence is high among children. The WHO reports that, of the 20 countries with the highest burden of HIV disease among pregnant women, 10 (Botswana, Cameroon, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Uganda, Zambia and Zimbabwe) have scaled up provider-initiated testing and counseling and HIV rapid testing to at least 75 percent of their antenatal care facilities.38

of pregnant women received an HIV test and 45 percent of women testing positive actually received antiretroviral therapy.37

Abstinence-until-marriage and partner reduction

Critique of PEPFAR I policies focused on the requirement that at least two-thirds of sexual transmission prevention funds be given to agencies and organizations that promote abstinenceuntil-marriage and partner reduction/faithfulness programs only.14 PEPFAR II policies have removed the abstinence/faithfulness programs funding clause, yet a large portion of funds are allocated to activities promoting delayed sexual debut, monogamy, fidelity and partner reduction. Despite some progress achieved under the previous PEPFAR policy, nongovernmental organizations (NGOs) and other organizations may be reluctant to promote contraception services or family planning because of their fear of losing PEPFAR funding.39

Despite some progress achieved under the previous PEPFAR policy, non-governmental organizations (NGOs) and other organizations may be reluctant to promote contraception services or family planning because of their fear of losing

Since the early 1980s, some evidence from the United States suggested that teen pregnancies or pregnancies out of wedlock were one of the primary causes of poverty. In 1981, President Reagan passed the Adolescent Family Life Act with the main idea of preventing premarital teen pregnancies by creating family-centered programs to promote chastity and self-discipline.40 The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 similarly established new funding and grants to states for abstinence-until-marriage programs, and prohibited advocacy for contraception use, except to discuss their failure rate.41 Another funding stream created by Congress in 2000 (now called Communitybased Abstinence Education), awarded grants directly to community organizations. In the first 5 years of the CBAE initiative, funding increased more than 450 percent; from US$20 million to US$113 million; in 2009, funding decreased to US$99 million.12

PEPFAR funding.39 16 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Under the Bush Administration, condom Under the Bush Administration, condom use and distribution programming were discredited, and the use and distribution effectiveness of condoms in preventing the spread of HIV questioned.14 PEPFAR I policies reflected this position programming were by increasing the funding requirements for abstinenceuntil-marriage programs, which in effect reduced discredited, and the possible funds for condom distribution and advocacy.

The Abstinence—Be faithful—Consistent Condom use effectiveness of condoms (ABC) policy under PEPFAR I emphasized condom in preventing the spread promotion and distribution only for specific populations, such as discordant couples, sex workers and men who of HIV questioned.14 have sex with men. The emphasis on abstinence-untilmarriage created an anti-condom atmosphere and further stigmatized HIV-positive people.42 In 2006, 17 of 20 country teams reported that fulfilling the spending requirement, including OGAC’s implementing policies, hampered their ability to respond to local prevention needs. 12 In 2008, Congress replaced the mandatory funding requirement directing 33 percent of prevention funds to the AB portion of ABC with a mandatory reporting requirement—programs need to submit a justification if less than 50 percent of prevention funds in a generalized epidemic are used for AB activities. The impact of this change is not yet known, but many implementers on the ground suggest that it continues to promote a bias toward abstinence interventions.43 Despite the shift from the “funding requirement” to the “reporting requirement,” the ABC guidance has not yet been updated.14, 44, 45 Revised policy guidance is needed to reflect the new policy, since the guidance serves as the framework for HIV programming.

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 17

Illustration of prevention funding allocated according to OGAC’s policies12

However, the FY 2010 Country Operational Plan guidance does note the requirement change: In countries with generalized HIV epidemics, each country team whose sexual transmission prevention strategy provides less than 50 percent of prevention funding for activities promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction, must submit a justification that explains the rationale given the epidemiologic context, contributions of other donors, and other relevant factors. Under the reauthorization legislation, the U.S. Global AIDS Coordinator is required to report to the appropriate Congressional committees on the justification for these decisions.46 This change in policy also fosters greater flexibility in prevention programming.

Prevention programs should be closely aligned with the country-specific profile of the epidemic. Country teams should ensure that, at the portfolio level, the combination of prevention activities supported provides comprehensive coverage of the most affected populations and localities, and that program content explicitly addresses the key drivers of the epidemic. This may mean realignment of activities to ensure that “hot spots” (areas of high transmission) are adequately covered with enough intensity of interventions.46 A significant concern with PEPFAR II’s policy on partner reduction (abstinence-until-marriage and fidelity) is that it is aimed specifically at youth, while evidence shows that married women are at highest risk of contracting HIV.47 Evidence also indicates that many countries in sub-Saharan Africa

18 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Evidence indicates that many countries suffer from high incidence rates in in sub-Saharan Africa suffer from high their respective adult populations, but not necessarily in the youth incidence rates in their respective adult populations. Yet more funding populations, but not necessarily in the is allocated for youth-centered programs than for adult-focused youth populations. Yet more funding is interventions.2, 48 Data from many sub-Saharan countries indicate allocated for youth-centered programs that married young women are than for adult-focused interventions.2, 48 more likely to be HIV-positive than their unmarried peers because they have sex more often, use condoms less often, are unable to refuse sex with their husbands, and have partners who are more likely to be HIV-positive.49 PEPFAR and family planning. Family planning is one of the wrap-around services delineated in the PEPFAR II legislation, though it has acknowledged that “platforms for these services are underdeveloped or underutilized.”50 Under PEPFAR II, programs will focus on linking HIV/ AIDS with family planning services. The implementation of this policy remains to be seen; many practitioners on the ground are still unclear as to whether HIV funds can in fact be used for family planning services, because specific guidance on this issue has not yet been released. However, the FY 2010 country operational plan guidance notes that family planning is an important component of the prevention care package of services for people living with HIV/AIDS, particularly for women accessing PMTCT services. This guidance also contains provisions to include family planning in HIV prevention programs.46

PMTCT and family planning: the case of Kenya Recent research has found that linking family planning with HIV services is effective.51 In Kenya, PMTCT comprises about half of all prevention funding. OGAC has reported that its services are expanding rapidly in all eight provinces, with the number of PMTCT sites increasing from 250 in 2004 to 1,084 by mid-2006. The Kenyan Ministry of Health reports that uptake of services varies greatly across regions and that family planning, a key component of WHO guidance for PMTCT, is not widely available across Kenya.52 Although more research is needed on the exact impact of family planning programs on those living with HIV, experts have found that integrating family planning with other HIV services is effective; there also have been calls for incorporating family planning into HIV-discordant couples counseling.53

Correct and consistent condom use Condoms have been a key component of HIV prevention programs since the early days of the pandemic.

Both male and female condoms provide a barrier to HIV transmission. More than 90 percent of HIV is

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 19

Condoms were given lower priority than programs that emphasized abstinenceuntil-marriage on selected at-risk populations.

transmitted through sexual contact—about 85 percent via heterosexual sex.54 The risk of HIV infection can be lowered by 80-90 percent with consistent and correct use of condoms.55 Researchers estimate that condoms are used in only 9 percent of sexual acts worldwide and that 19-24 billion condoms are needed worldwide to prevent the transmission of HIV and other sexually transmitted infections.56, 57 Female condoms have the potential to prevent HIV transmission to women.58, 59

PEPFAR I language included correct and consistent condom use as part of its ABC strategy.

However, as mentioned above, condoms were given lower priority than programs that emphasized abstinence-until-marriage and be faithful/partner reduction, and condom distribution was focused on selected at-risk populations.

PEPFAR II has more specific language regarding condom use, as the word ‘condoms’ has been replaced by ‘male and female condoms’ throughout the document. In Section 101(b)(2)(C)(iii), the policy encourages “the correct and consistent use of male and female condoms and increasing the availability of, and access to, these commodities.”8 This policy shows a greater acceptance and awareness of contraceptive methods that empower women and give them more control over their bodies. In addition to a strong emphasis on condom use, efforts are needed to counter the anticondom atmosphere and the fear of losing funding that were created by PEPFAR I policies.

USAID coordinates the procurement of male and female condoms under PEPFAR. Given that the U.S. supplied 1.9 billion condoms in the period from 2004 through 2007 alone, USAID plays an important role in shaping the global trends in reproductive and sexual health supplies.60 As one of the largest donors of HIV prevention, treatment and care, OGAC’s commitment to increasing access to female condoms could have a profound effect on women’s lives.61 The HIV epidemic in subSaharan Africa (SSA) is concentrated among women—currently, 60 percent of those infected with HIV in SSA are women.2 The U.S. has dramatically increased distribution of female condoms in recent years, with shipments growing from 1,109,000 in 2003 to 8,743,000 in 2007.

However, even considering these increasing numbers, female condoms were still just 1.6 percent of total U.S. condom procurement in 2007.62 Furthermore, since the implementation of PEPFAR in 2004, only five PEPFAR focus countries (Haiti, South Africa, Tanzania, Vietnam and Zambia), have ever received U.S.-procured female condoms. Between 2001 and 2007, USAID shipped 18 million female condoms, compared to almost 3 billion male condoms.60 20 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

In addition to a strong

emphasis on condom use, efforts are needed to counter the anti-condom atmosphere and the fear of losing funding that were created by PEPFAR I policies.

Furthermore, while USAID has supported female condom programming in more than 20 countries through AIDSMark, many of these projects were pilots and funding was not sustained for more than three or four years.60 By this measure, and in comparison to the substantial unmet need, U.S. investment in female condom procurement falls short.63 Lack of policy guidance. Ample evidence indicates that male condoms prevent HIV infections and transmission. The current policy guidance is to promote both male and female condoms to “high risk� groups only, instead of promotion at the level of the general population. Although a targeted approach may be more effective (from both public health and financial perspectives) if the epidemic is limited to the high-risk groups, it is less effective for a generalized epidemic and the association between condoms and marginalized populations can result in stigmatization of condom use.60 In countries with a more targeted epidemic, policies and plans should be in place to adapt their strategies should the epidemic start to become more widespread.

Despite the fact that the reauthorization of PEPFAR has included female condoms in its text, there has not been much support for them on the ground. USAID does not have specific guidance on the promotion of female condoms; at the country level, the decision about female condoms often rests with the USAID officer, mission director or ambassador rather than on evidence-based research about the efficacy of the product.63 Due to the lack of guidance from the U.S. government, the female condom remains only a marginal product.

Inefficient procurement policies. In 2002, USAID set up a commodity fund to provide its missions and programs with free male and female condoms to address the need for HIV prevention.62 However, in 2006 PEPFAR focus countries lost their eligibility to receive free male and female condoms, as the commodity fund only finances male and female condoms for non-focus PEPFAR countries. The PEPFAR focus countries may use PEPFAR prevention funds to purchase condoms, yet the allocation available to purchasing condoms is limited. Given the relatively high cost of the female condom (i.e., US$0.59 per unit) compared to the male condom (i.e., US$0.04 per unit), program coordinators have little incentive to request the higher-priced product.

Male circumcision (MC) The PEPFAR legislation does not elaborate on MC or provide recommendations on how to expand MC services. However, the PEPFAR II initiative highlights MC as an “important means of

Although a targeted approach may be more effective (from both public health and financial perspectives) if the epidemic is limited to the high-risk groups, it is less effective for a generalized epidemic and the association between condoms and marginalized populations can result in stigmatization of condom use.60 United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 21

The PEPFAR II initiative preventing or reducing the transmission of HIV.”64 MC comprises 1 percent of PEPFAR funding worldwide; PEPFAR funding on MC worldwide is reported to be a total of US$33.1 million dollars.48 However, there is little information regarding how much is allocated for MC in each country. In PEPFAR II documents, OGAC cites support for national MC initiatives in Zambia, Swaziland, and Botswana, three countries with low MC rates and high HIV prevalence. More information is needed regarding the number of people these programs are reaching and the quality of services offered.

highlights MC as an “important means of preventing or reducing the transmission of HIV.”64 MC comprises 1 percent of PEPFAR funding worldwide.

The evidence for MC in preventing transmission in men via heterosexual sex is compelling. After a series of observational studies that suggested that high rates of circumcision were associated with low HIV transmission rates, three randomized controlled trials offered robust evidence for MC, demonstrating a 50-60 percent reduction in the risk of acquiring HIV.65-67 In fact, a trial in Uganda was terminated, as it was deemed unethical to withhold circumcision from men in the control group.

Since then, MC has become a key strategy for reducing risk of transmitting HIV/AIDS to men.

The MC programs in sub-Saharan Africa have not been sufficiently brought to scale. In the past years, despite mounting evidence for MC, international donors and funding mechanisms, including PEPFAR, have allocated limited funds for MC. Though experts have said that MC should be part of a harmonious, comprehensive, culturally relevant prevention strategy, the trend among donors has been simply to add it as another budget item for prevention. The FY 2010 PEPFAR operational plan is however finally focusing more on MC, allocating additional funding for voluntary medical male circumcision to respond to the huge demand for these services, increasing funding for MC in high HIV prevalence countries, such as Swaziland, and providing funding to initiate MC programs in countries where other funding is not available.68 Studies assessing MC acceptability in sub-Saharan Africa (SSA) found that many people were concerned about the price and safety of such procedures, particularly in countries with weak health systems and health worker shortages.69 As MC services are become more readily available, ensuring quality MC services will be a key component in determining its effectiveness and its utility.

Another concern is whether men will engage in riskier sex behavior following circumcision. Studies warn that men who do not wait until their incisions have healed before engaging in sex have an increased risk of transmission compared to those who wait the recommended time.67 Other types of risky behavior include increased numbers of sexual partners and lack of condom use. To avoid risky behavior that may offset the benefit of circumcision, experts stress the importance of comprehensive counseling services and community campaigns, as it is very important that the MC message be communicated effectively.70 Health workers need to reinforce the message that circumcision is not a cure, but only one part of a broader prevention approach.

22 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

In general, sub-Saharan African countries with the highest HIV prevalence rate also have low rates of MC; WHO recommends that such countries consider scaling up MC services.71 For example, Swaziland has an MC rate of 8 percent and an HIV/AIDS prevalence rate of 26 percent. MC may vary greatly within countries, such as Kenya. Thirteen countries in SSA have now made MC a priority in preventing HIV transmissions.

HIV prevalence and rates of male circumcision71

Impact of MC on women. There is little evidence to suggest that MC has direct benefit for women, though researchers have suggested that reduction in HIV incidence among circumcised men may lead to an indirect benefit to women in generalized epidemics. One randomized control trial (RCT) conducted in Rakai, Uganda, found no reduction in transmission between circumcised HIVinfected men and their female partners.72 UNAIDS cites no direct benefits of MC for women, yet admits that indirect benefits can include lower the risk of contracting STIs and cervical cancer.

Though this may have a positive effect on women’s health, experts warn that MC carries risk for women as well.

One risk associated with MC is that if men receiving circumcision engage in risky behavior (i.e., neglecting the use of condoms and increasing the number of partners), women could be at increased risk of infection with HIV or other STIs. Furthermore, a UNAIDS report states that a “women’s ability to insist that their partners use condoms or adhere to other safer sex practices may be undermined if circumcised men believe that they are at low risk of HIV infection.”63 This in turn could lead to increased violence against women, as well as stigmatization of HIV-positive United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 23

Initial PEPFAR policies related to abstinence-oriented funding stigmatized the use of condoms and counseling services, often overlooking the local trends in transmission and hampering the prevention efforts of many NGOs against the HIV epidemic.14 women. Another setback may be that increased funding for MC may mean fewer funds for sexual and reproductive health for women.

There are also concerns that increased rates of MC could potentially lead to some confusion regarding female circumcision (or female genital mutilation, FGM).70 Though there have been no reports thus far linking MC with FGM, this remains a concern as there is no medical benefit to FGM. Moving forward, a clear distinction must be made to avoid confusion.

More research on the impact of MC programs on women is needed to further develop effective MC programming. In the meantime, alternative strategies are needed to address the fact that women continue to be disproportionally affected by HIV/AIDS.

HIV/AIDS stigma and discrimination Living with HIV/AIDS is difficult under any conditions, but it is especially challenging in developing countries where HIV-positive people commonly face discrimination and exclusion from their societies.73 In the U.S., domestic policies protect people living with HIV/AIDS by ensuring that their rights and freedoms are protected by laws.74 In many developing countries, there are no or limited protective legal frameworks to assist HIV-positive persons with the stigma and discrimination they face.57 PEPFAR I provisions did not outline any specific strategies for combating stigma and discrimination, nor did it provide access to confidential and discreet testing, counseling or health care services.61 Initial PEPFAR policies related to abstinence-oriented funding stigmatized the use of condoms and counseling services, often overlooking the local trends in transmission and hampering the prevention efforts of many NGOs against the HIV epidemic.14 PEPFAR II policies recognize the destructive role of stigma and discrimination, and acknowledged that they impede HIV/AIDS prevention and treatment efforts. In addition, PEPFAR II provisions acknowledge the need to support the rights of marginalized populations. Through PEPFAR II, OGAC seeks to “advance the rights of populations which face stigma and expand equal access to care”.33 PEPFAR’s current language promotes support for marginalized populations and seeks to reduce the toll of stigma and discrimination on HIV/AIDS treatment and care.

Evidence shows that stigma and discrimination impede HIV/AIDS prevention efforts.73, 75 Health care workers in many developing countries look down on HIV-positive persons; such a practice discourages people from testing or counseling. This delay in care-seeking likely leads to greater difficulties associated with treating a more advanced stage of disease. The day may also be associated with lack of sufficient precautions taken to decrease the risk of transmitting the disease.76 Discrimination is more problematic for marginalized populations, such as men who have sex with 24 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

PEPFAR II policies that men, commercial sex workers or disabled persons, as they face stigma on two levels: their HIV status and their profession, affiliation or status.77 In the 2010 UNAIDS report of the Secretary-General, it was stated clearly that stigma and discrimination continue to beset people living with HIV and individuals in marginalized groups who are at greatest risk of infection.78

resulted in failure to protect and adequately educate and treat marginalized populations

One of the ways in which OGAC is addressing stigma with regard to HIV/AIDS and discrimination is to “emphasize support for have been retained. marginalized populations as an essential part of country engagement.”79 PEPFAR II policies outline partnership frameworks that aim to increase country ownership of and engagement in the fight against HIV/AIDS. The notion is that countries will develop policies to alleviate stigma and increase PEPFAR-funded services and treatment, especially for marginalized populations. However, initial evidence shows that most of the framework agreements do not incorporate the initiative’s goal of stigma-free programs and instead fail to address the need for legal and policy reform with respect to curtailing stigma and discrimination.

As of 2008, one in three countries still did not have laws protecting people with HIV/AIDS from discrimination and most countries lack this protective framework for marginalized populations.

UNAIDS reported that only 26 percent of countries have laws protecting men who have sex with men from discrimination, 21 percent have anti-discrimination laws protecting sex workers, and 16 percent have such laws protecting injection drug users. Meanwhile, 32 percent of countries have laws that interfere with the ability of NGOs to provide HIV-related services to men who have sex with men, 45 percent have laws that interfere with delivering services to sex workers, and 40 percent of countries have laws that interfere with delivering services to injection drug users.77 The national framework agreements have been designed to “describe plans to encourage leadership from governments to create non-discriminatory policies” and “address causes and consequences of HIV-related stigma.”44 The guidance however does not call specifically for a review of or needed changes in laws and policies related to the marginalized populations that are also the populations at highest risk of becoming infected with HIV. The section in the PEPFAR guidance on stigma and discrimination does not direct the framework of progammatic approach to address the causes and consequences of HIV-related stigma specifically, though one example provided is “incorporating prevention with Positives programs (where supporting HIV positive patients to disclose their HIV status supports broader public health prevention goals) into the training of healthcare workers and lay counselors.”44 The guidance also does not address people with disabilities explicitly, nor does it name traditionally recognized marginalized populations, such as men who have sex with men and injecting drug users. The only group referred to specifically in the policy guidance section on stigma and discrimination is people living with HIV/AIDS.44 United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 25

Since the adoption of the It is clear that, although OGAC recognizes the need to reduce HIV-related stigma and discrimination on paper, more action is needed to ensure that governments alleviate such practices. In many cases, developing countries lack the legal framework to protect individuals from discrimination.57 In other cases, PEPFAR’s own policies stand in the way of adequately reaching out to marginalized populations, such as commercial sex workers or injection drug users, who do not have adequate access to HIV/AIDS services because PEPFAR funding is restricted for those engaged in certain activities.80, 81

Marginalized or most-at-risk populations (MARPS)

anti-prostitution policy in 2003, studies have indicated that excluding contact with and help for commercial sex workers —in many countries, the group with the highest risk of infection— hampers efforts to reduce

The PEPFAR II language specifically acknowledges people engaged in high-risk activity, also called the HIV epidemic.85 ‘marginalized populations,’ as mobile populations, persons involved in prostitution, persons who use injection drugs, men who have sex with men, persons in uniformed services, and prison populations.

Evidence shows that these populations are often the most HIV/AIDS-affected and at-risk populations, and that the ABC approach (i.e., abstinence until marriage, be faithful to one’s partner or reduce the number of partners, and correct and consistent use of condoms) advocated through PEPFAR language and programming is less effective or relevant for these populations.12 OGAC recognizes that marginalized populations are highly stigmatized and discriminated against, and often do not have adequate access to health care and counseling. Thus, PEPFAR II policies emphasize support for marginalized populations as an essential part of country engagement and supports policy changes that would create a safe environment for these populations to seek health and support services. Despite this recognition, PEPFAR II policies that result in failure to protect and adequately educate and treat marginalized populations with regard to HIV/AIDS have been retained.

Commercial sex workers and the anti-prostitution pledge. In 2003, the U.S. government (under PEPFAR I) designated the eradication of prostitution as a central strategy to curb the epidemic. The policy contained two related clauses: one prohibiting funds to any organization that advocates for the legalization of prostitution and a second requiring all organizations that receive federal funding for HIV/AIDS activities to adopt organization-wide policies explicitly opposing prostitution and sex trafficking (whether or not the organization worked with sex workers).7 Until 2005 this clause only affected international NGOs, yet in 2005, domestic U.S.-based NGOs were also added to the policy.

In PEPFAR II, this anti-prostitution policy has not been overturned, though there have been numerous lawsuits and oppositions to this policy.82-84 On May 9, 2009, the New York District Court 26 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Although PEPFAR II language supports government policies that granted a preliminary injunction to Plaintiffs Alliance for Open Society International and should ensure that MSM have Pathfinder International, as the court held that the policy requirement violated the equal access to health care, HIV/ First Amendment because it compels speech, discriminates based on viewpoint and is AIDS information and supportive not narrowly tailored to achieve the goals set forth by Congress. In 2008, InterAction services, the policy imposes and the Global Health Council requested to little pressure on countries to join the case to protect their members. The District Court permitted an amendment of undertake such policy reforms. the Complaint to add the associations as plaintiffs, rejecting the Government’s claim that they lacked standing. On April 13, 2010 the Department of Health and Human Services amended regulations and USAID issued modified policy guidelines. However, these actions made only very slight, non-material modifications to the previous guidelines and regulations. The newly issued guidelines on the policy also did not change the District Court’s ruling or adequately address the problems with the policy. Today, the U.S. Government continues to enforce the policy requirements and guidelines against NGOs not covered by the preliminary injunction. Internationally-based NGOs, which are not exempt from the guidelines and regulations, continue to be adversely affected by them.

Since the adoption of the policy in 2003, studies have indicated that excluding contact with and help for commercial sex workers—in many countries, the group with the highest risk of infection—hampers efforts to reduce the HIV epidemic.85 Women in developing countries may turn to prostitution because they have no other means of supporting their families and no other ways to generate income.85 By limiting funding and prohibiting NGOs from helping this at-risk group, PEPFAR-funded programs are impeding access to adequate counseling and treatment services to this population.86 Men who have sex with men (MSM). Under PEPFAR II. OGAC calls for assistance for appropriate HIV/AIDS education programs and training targeted to prevent the transmission of HIV among men who have sex with men and to evaluate the effectiveness of prevention efforts among MSM, with due consideration to stigma and risks associated with disclosure.79 In many developing countries, MSM are stigmatized and discriminated against by society and by law. As of 2007, 85 UN member states still criminalized consensual same-sex acts.87 By law, homosexuality is criminalized in most African countries, including Kenya, Rwanda, Burundi.77 MSM are vulnerable to HIV infections, face discrimination in society and the workplace, and may be forced to turn to prostitution.88 Although PEPFAR II language supports government policies that should ensure that MSM have equal access to health care, HIV/AIDS information and supportive services, the policy imposes little pressure on countries to undertake policy reforms. The partnership frameworks, outlined in United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 27

In December 2009, the policy, do not offer stronger language on ensuring protection from discrimination and arrest; funding to Lesbian Gay Bisexual Transgender agencies in Africa is limited. According to internal Global Health Council meetings with the Office of the Global AIDS Coordinator representatives, new guidance on MSM will soon be published. Whether and how well they will be implemented under the Partnership Frameworks remains to be seen.

Congress lifted the 20 year-ban on using federal funding for domestic needle exchange programs, yet this did not apply to

Injection drug users and needle exchange policy.

Although the PEPFAR II initiative supports some funding earmarked for projects that provide outreach and education to drug international initiatives. users, it does not fund needle exchange programs, treatment for drug dependency or antiretroviral therapy targeted to drug users. In December 2009, Congress lifted the 20-year ban on using federal funding for domestic needle exchange programs, yet this did not apply to funding earmarked for international initiatives. The lifting of the needle exchange ban, along with political willingness from Ambassador Goosby, led to revised HIV prevention guidance for injection drug users. On July 16, 2010, OGAC released Comprehensive Prevention Guidance for People Injecting Drugs, which promotes the following interventions: community-based outreach programs, sterile needle and syringe programs and drug dependency treatment including medication assisted treatment.89 The guidance also calls for training of health professionals to deliver a comprehensive set of prevention services and “assessment of laws, policies, regulations, and barriers that impede comprehensive HIV prevention programs with IDUs.”89 In 2009, The Lancet published an article praising the PEPFAR-funded programs for providing ARV treatment to 2.1 million Africans living with HIV, yet criticized it for failing to reach “thousands of injection drug users in PEPFAR countries, many of whom have HIV.”90 IRIN, a humanitarian news and analysis network, estimates that there could be up to 3 million people who inject drugs, with more than 200,000 in Kenya and at least 250,000 in South Africa, including other non-focus countries.91 The debate on supporting or opposing clean needles to drug addicts is sensitive. Many argue that needle or syringe exchanges support drug use and do not convey a strong enough message on disapproving of the practice.91 There is no convincing evidence that such programs do cause unintended consequences, such as initiation of injecting among people who have not done so previously or an increase in the duration or frequency of illicit drug use or drug injection.92 Others, including the WHO and the American Medical Association, believe that a strategy that includes a needle exchange and support to drug users works to reduce the spread of HIV.92 There is compelling evidence that the needle exchange programs work in reducing the HIV transmission rate among drug users. The WHO reviewed 200 studies on this subject and found compelling 28 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

In 2009, The Lancet evidence that increasing the availability and utilization of sterile injection equipment for both outof-treatment and in-treatment injection drug users contributes substantially to reducing the rate of HIV transmission.92 For example, the review highlights one study that compared HIV prevalence in 103 cities in 24 countries—the HIV infection rate had declined by an average of 18.6 percent annually in 36 cities with needle and syringe programs, whereas it had increased by an average of 8.1 percent annually in 67 cities lacking such programs.93 These findings confirmed those of earlier reviews.94-96 Needle exchange programs alone are not able to control the HIV infection among drug users, but they are effective in helping to reduce it.

Counseling and testing

published an article praising the PEPFARfunded programs for providing ARV treatment to 2.1 million Africans living with HIV, yet criticized it for failing to reach “thousands of injecting drug users in PEPFAR countries, many of whom have HIV.”90

OGAC reports that in FY 2009, PEPFAR-funded programs supported counseling and testing for 29 million people, citing that counseling and testing is a “critical entry point to prevention, treatment, and care.” Unfortunately, there is little evidence to demonstrate that individual voluntary counseling and testing (VCT) has any impact on subsequent risk behavior or incidence.97 Stigma is a critical component of counseling and testing interventions— many people forgo counseling and testing (voluntary or otherwise) because of issues related to stigma. In such cases, data on the number of health facilities providing such services is not sufficient; more information is needed on how often these facilities are utilized by the general population. In addition, some people want to get tested, but do not have access to a health facility.17 Although there is information regarding the number of people receiving counseling and testing in the initial 15 PEPFAR focus countries, it is unclear whether services are voluntary or part of a larger provider-led effort.17, 98 Nor is there information regarding the types of people receiving such treatment, i.e., those living in urban or rural settings, members of the most at-risk populations (e.g., sex workers, injecting drug users, men who have sex with men), or age of the person receiving counseling and testing services. This information is necessary to assess counseling and testing programs. In addition to recommending that counseling be part of a provider-led effort instead of a voluntary initiative, experts suggest re-orienting counseling services to target couples, rather than individuals. Specifically targeting HIV-discordant couples in their homes may help reduce risky behaviors, though more research is needed to prove the effectiveness of this strategy.

HIV/AIDS treatment Since its inception, PEPFAR funding has directly supported ARV treatment for more than 2.4 million men, women and children.48 PEPFAR II’s five-year strategy states that “in partnership with country United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 29

governments PEPFAR is continuing scale-up of treatment to directly support more than 4 million people in its next phase”.79 OGAC plans to achieve a threshold of 85 percent ARV prophylaxis or treatment of HIV-positive pregnant women and 65 percent diagnostic coverage of early infection.

The plan will also support pediatric treatment in generalized epidemics. Furthermore, as part of the GHI, they aim to “integrate treatment programs with prevention and care portfolios, other health programs, and larger development efforts.”79 However, with only a slight increase in overall PEPFAR allocation for FY 2010 and a renewed commitment to prevention services, it is unclear whether funds will be sufficient to expand programming while also retaining those already receiving treatment.

Since their development in the late 1980s ARVs have allowed those living with HIV and AIDS to manage their disease; drug regimens that included combination therapies (highly active antiretroviral therapy, HAART) are more effective in managing the illness and drug resistance is less likely to develop.99 Another benefit of treatment is that, as viral load drops, the person is less infectious and therefore less likely to transmit HIV.100 However, there still is no cure for HIV/AIDS—once a person initiates treatment, he or she needs to continue it for life.

Number of people receiving treatment versus number of people in need38, 101

*Kenya’s figure for the number of people in need of treatment is self-reported. No data available for the number of people on treatment in Sudan.

30 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Regional funding for treatment, 2009 (in millions)9

The last several years have witnessed a decline in drug costs in developing countries from US$15,000 per year to less than US$150.29 Yet, in 2008, of the 2.7 million new cases of HIV reported worldwide, only 1.1 million people actually received treatment—and this uses the old WHO guidelines regarding starting ARVs when CD4+ T-lymphocyte counts fall below 200 cells per cubic millimeter of blood.2 WHO’s new guidelines for treatment initiation add to the number of eligible people awaiting treatment, as those with CD4+ T-lymphocyte counts of less than 350 cells per cubic millimeter of blood should initiate ARV therapy. OGAC plans to expand programming to meet the new WHO guidelines, though this will be a challenge given limited funds.79 Experts have said that the new guidelines could be lifesaving, but that implementation will depend largely on donor commitment.

Antiretroviral adherence and patient retention HIV/AIDS programs have three main components: diagnosis, starting people on treatment and ultimately retaining them on lifelong treatment. ARV adherence in developing countries can be a challenge. For example, many patients diagnosed with malaria in sub-Saharan Africa do not complete their prescribed treatment regimen (e.g., a one-week course that consists of one to two doses per day); this can contribute to the development of drug resistance.102 PEPFAR II policies mention the problem of ARV adherence only once, calling for an “evaluation of the impact of treatment and care programs on five-year survival rates, drug adherence and the emergence of drug resistance” no later than four years after its publication.79

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 31

Reports are

PEPFAR’s main success has been getting more than 2 million people on ARVs, which has been well documented.103 However, reports are inconclusive with to ARV adherence and regard to ARV adherence and treatment retention. A study in sub-Saharan Africa on the retention of patients on HIV treatment retention. treatment showed that, on average, almost 40 percent of patients were no longer on treatment after 2 years.104 Other programs have lost more than half of their patients in the first two years, sometimes due to death, but often patients simply terminated follow-up care.105-110

inconclusive with regard

From OGAC’s metrics and publications it is unclear whether their “‘new” patients are actually new or are returning to treatment after dropping out of care. In a July 2010 report to Congress, OGAC delineates cost of treatment per first-line patient, second-line patient, and others.111 An additional problem for those who return to treatment is that non-adherence to ARVs may cause drug resistance, which makes the drugs ineffective and makes a new drug regimen more costly. A more coherent and transparent metric system is needed to be able to measure and analyze adherence to ARVs. In addition, policies that increase the adherence rate are needed.

New government partnerships OGAC promotes the use of partnership frameworks as the policy mechanism to move the PEPFAR initiative away from an emergency response plan to a more sustainable AIDS relief plan. The purpose of the partnership frameworks is to provide a five-year joint strategy for cooperation between the U.S. government, the partner government, and other partners to address HIV/AIDS through technical assistance and support for service delivery, policy reform, and coordinated financial commitments.44 The partnership frameworks are an example of an evidence-based policy that supports country ownership, national HIV/AIDS plans and making the PEPFAR strategy individualized to the specific countries’ needs. A key objective of the partnership framework is to ensure that governments are at the center of decision-making, leadership and management of their national HIV/AIDS programs and, ultimately, their national health systems, and that their efforts embrace the contributions of civil society.44 Although the new partnership frameworks are not legally binding, the partner governments formally commit to HIV/AIDS policy reforms related to U.S. government engagement.

Greater cooperation with governments should help address the “brain drain” effect created by PEPFAR I’s practice of drawing health care workers from other public health programming.112 A study in Zambia showed that “perks gained from working on PEPFAR-supported programs (such as higher salaries, paid overtime and training opportunities) combined with limited incentives to remain in the public sector (particularly the lack of opportunities for career progression) lead to an internal brain drain” in which government workers leave their jobs to work for implementing organizations funded through PEPFAR, creating critical shortages in the public sector.113 As most of the partnerships were signed in the latter half of 2009, it is premature to say whether the goals envisaged by the partnership frameworks will come to fruition or whether the process will be smooth.

32 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Despite partnership frameworks between Despite partnership frameworks between the U.S. government and 20 (as of January 2010) countries, the the U.S. government accompanying implementation plans have yet to be released. These implementation plans provide specific and 20 countries, details related to the activities and organizations responsible for carrying out and achieving the objectives, the accompanying as well as commitments and targets articulated in the agreement. Plans also outline the policy for monitoring implementation plans and evaluation of partnership successes. In addition, the have yet to be released. language used in the text of the framework partnerships is vague—the aim of the partnerships is to include the governments more in the planning and policy-making process, yet the guidelines do not indicate whether governments will actually receive a greater portion of PEPFAR funds than in the past to scale up their efforts.113 The vagueness of the language, the provision of the majority of PEPFAR funding to non-governmental recipients and the ongoing development of the Country Operational Plans (COPs) blurs the vision of increased country ownership. The implementation plans will be the key to determining whether the governments have a greater voice in the management and planning functions, and to designating accountability.114 In August 2010, PEPFAR published guidance on comprehensive HIV prevention for people who inject drugs and, according to internal Global Health Council meetings with the Office of the Global AIDS coordinator representatives, it will also soon published guidance on MSM. We have however yet to see whether and how well this guidance will be implemented under the Partnership Frameworks.

Finally, the level of civil society involvement in helping to shape the partnership frameworks is unclear. Civil society is mainly comprised of people living with HIV, community-based workers, health professionals, and others who have knowledge and expertise. This perspective needs to be incorporated formally into the partnership framework development process.

Transparency in PEPFAR policies and programs Current statistics cited by OGAC do not provide adequate information regarding the impact of PEPFAR programming. For example, OGAC’s fifth annual report on the initiative states that the U.S. government supplied more than 2.2 billion condoms worldwide between 2004 and 2008, yet it is unclear whether these condoms were used and used properly.48 Over the years, some of the information presented was misleading, e.g., as of September 30, 2009, OGAC reported direct support of lifesaving antiretroviral treatment for more than 2.4 million men, women and children (including 16 million pregnant women via PMTCT programming), yet this number included 1.3 million people jointly covered by The Global Fund for AIDS, Tuberculosis and Malaria.48 Although PEPFAR and the Global Fund co-fund many programs, they may focus on different aspects of these programs, such as provision of services versus health worker costs versus other infrastructure support. This overlap United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 33

in reporting has now been addressed and documentation delineates the roles and contributions of PEPFAR and the Global Fund.

Most of the available information regarding the details of PEPFAR programming can be found in the COPs, though the language is often vague. This may be due to variability in the level of detail provided by the implementing organizations regarding their programming. For example, there is a mention of “supporting sex workers” in Kenya’s COPs, yet it is unclear what type of support was given or how this was done. In addition, programs providing “alternatives to sex work” were mentioned, with no details on what was included in the programming or its level of impact. While the COPs provide a breakdown of funds according to subprime partners, it is unclear how much money goes to any single issue area. Increased transparency regarding program-specific funding at the country level is needed to assess the true effectiveness of PEPFAR-supported programs.

PEPFAR funding to countries does not appear to correlate with the country’s HIV prevalence. The hardest hit countries of Swaziland, Botswana, and Lesotho have HIV prevalence rates of 26 percent, 24 percent, and 23 percent respectively; yet, PEPFAR funding for these countries in FY 2009 was only 0.4 percent , 2.6 percent and 0.4 percent of the total budget for Africa, respectively.48 Conversely, Ethiopia’s HIV prevalence is 2.1 percent, yet it received nearly 10 percent of PEPFAR’s Africa budget.

However, this report does not consider funding from other sources, such as the Global Fund or other bilateral assistance, that may supplement the HIV funding to some countries.

PEPFAR funding versus HIV prevalence9

34 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

In addition to the lack of transparency with regard to allocations, discrepancies between HIV programmatic funding and HIV needs can be seen in the case of Mozambique, where 68 percent of heterosexual transmission occurs in adults over 25 years of age, a chronically underserved population.2 OGAC reports that HIV incidence is highest in the 15-24 age range and claims to be programming accordingly.115 This discrepancy in statistical reporting between donors is counterproductive and should be rectified, with greater coordination among donor agencies and host country governments.

HIV/AIDS program monitoring and evaluation To understand more clearly how PEPFAR-supported programming has affected the prevention and treatment of HIV/AIDS, a strong monitoring and evaluation (M&E) mechanism is needed.

Without a concrete assessment of the situation on the ground, it is difficult to make informed, evidence-based decisions. Through PEPFAR II, OGAC highlights the importance of monitoring and evaluation. According to their five-year strategy, they plan to: “support countries in reassessing their prevention response through mapping the epidemic, identifying the populations most impacted by new infections, and updating prevention strategies based upon these data; contribute to international efforts to develop harmonized indicators and new surveillance methodologies; and support and evaluate promising and innovative practices to determine effectiveness and impact of such interventions at both the country and global level.”79 Coordination among donors is needed to gather evidence from recipient countries; this evidence can inform policy. WHO and UNAIDS have launched “know your epidemic” and “know your response” efforts to rectify the lack of alignment between HIV needs and actual HIV programming.116 WHO has released a chart with clearly outlined definitions of interventions, indicators and outcomes that can be used to evaluate program effectiveness. Such documentation is important because terms such as “fidelity” and “male circumcision” can be defined differently; defining these terms and setting metrics streamlines the evaluation process.117 Moving forward, programming should use the evidence gathered to support the logic behind its allocations.

Conclusion Overall, the PEPFAR initiative has injected both much-needed funding and structure into the global HIV/AIDS response landscape—for prevention, counseling and testing, treatment and care. Millions of people have benefitted from these services and more will continue to do so in the future.

The policies articulated in PEPFAR II are an improvement over those of PEPFAR I, which had a number of provisions that were not effective and, in some cases, diminished the ability of providers to offer adequate services. But PEPFAR II should still address certain problems: The retention of the anti-prostitution pledge limits the ability to deliver services to this atrisk population; The most at-risk populations experience stigma and discrimination, resulting in a reluctance to seek preventive, counseling and treatment services; United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 35

The gap between those needing treatment and those receiving it will likely increase as funding levels off and more people are eligible for treatment under the new WHO guidelines; Transparency and monitoring and evaluation programs are needed to better demonstrate how PEPFAR-funded programs are responding to country needs and how interventions are meeting their targets of delivering care and improving health outcomes.

The greatest challenges the PEPFAR initiative (and other HIV/AIDS programs) faces in coming years are how to balance the need for treatment and the need for prevention, and how to sustain funding at adequate levels. As noted earlier, flat funding has hampered treatment programs in PEPFAR countries. It is well-known that global health efforts cannot stem or reverse the pandemic with a focus on treatment alone—robust prevention efforts are essential. Yet the growing need for treatment—to sustain those already receiving ARVs and to add to their ranks the people whose CD4+ count indicates their need for medication—is also essential, especially as the U.S. has committed in both PEPFAR I and PEPFAR II to providing treatment indefinitely to those living with HIV infection.

36 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

United States Global Tuberculosis Policy

T

uberculosis (TB) is an airborne disease that is preventable and curable. In most cases, when detected early and fully treated, people with the

disease become non-infectious and eventually cured.

In 2007, there were an estimated 13.7 million chronic active cases, 9.3 million new cases, and approximately 1.7 million deaths.118 In 2008, this number rose to almost 1.8 million, of which 456,000 deaths were among HIV-positive people.

T oday, TB is the leading cause of death among people who are HIV-positive. In Africa, HIV has been the single most important factor contributing to the increase in the incidence of TB since 1990.119 The development of drug resistance is a growing problem, as multiple-drug resistant (MDR) and extensively-drug resistant (XDR) TB are costly and difficult to treat.

T he distribution of tuberculosis is not uniform across the globe. About 80 percent of people in many Asian and African countries have positive tuberculin tests, while in the U.S. only 5-10 percent of the population is TB-positive.

T he proportion of people who become sick with tuberculosis each year is stable or falling worldwide, but because of population growth, the absolute number of new cases is still increasing.119 T he five countries with the highest incidence of cases in 2008 are: India (1.6-2.4 million), China (1.01.6 million), South Africa (0.38-0.57 million), Nigeria (0.37-0.55 million) and Indonesia (0.34-0.52 million).120 India and China alone account for an estimated 35 percent of all TB cases worldwide.

I n the United States, about 15,000 new TB cases and 840 deaths were recorded in 2008.121 The overall number of TB infections and deaths has been decreasing in the U.S.; 59 percent of all TB cases in the U.S. were detected in foreign-born persons.

Estimated TB Prevalence, Incidence and Mortality in Selected Regions, 2008118 WHO Region

Incidence (thousands)

Percent of global total

Rate per 100,000 population

Prevalence (thousands)

2,828

30

351

3,809

473

385

48

The Americas

282

3

31

221

24

29

3

Eastern Mediterranean

675

7

115

929

159

115

20

Europe

425

5

48

322

36

55

6

Southeast Asia

3,213

34

183

3,805

216

471

27

Western Pacific

1,946

21

109

2,007

112

216

15

GLOBAL Total

9,369

100%

139

11,093

164

1,322

20

Africa

Rate per Mortality Rate per 100,000 (thousands) 100,000 population population

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 37

The U.S. government response to TB The 2008 report to Congress on tuberculosis states that the U.S. Government is committed to achieving the targets set forth in the Stop TB Partnership’s Actions for Life—The Global Plan to Stop TB 2006–2015, to halve TB prevalence and deaths by 2015, compared to country levels in 1990.122 The United States Agency for International Development is the leading agency for U.S. international TB control, providing bilateral assistance to national programs to implement the World Health Organization’s Stop TB Partnership at the country levels.123 USAID started its TB program in 1998 and has since established bilateral programs in more than 40 countries; between 2000 and 2008, USAID spent US$777 million to support TB programs worldwide.124 Over the past six years, the United States has helped to provide effective treatment for 10 million people with TB in 78 countries. USAID works with the Office of the Global AIDS Coordinator (OGAC) to achieve U.S. TB objectives.

Currently, OGAC is the lead agency for the U.S. government response to TB and HIV/AIDS coinfection. The Centers for Disease Control and Prevention (CDC) provides technical support and assistance to ministries of health and both USAID and OGAC; the National Institutes of Health (NIH) leads the international biomedical research effort.125

The 22 High-burden Countries126

Map notes: The 22 High-TB-burden Countries according to WHO are: Afghanistan, Bangladesh, Brazil, Cambodia, China, Democratic Republic of Congo, Ethiopia, India, Indonesia, Kenya, Mozambique, Myanmar, Nigeria, Pakistan, Philippines, Russian Federation, South Africa, Thailand, Uganda, United Republic of Tanzania, Vietnam, Zimbabwe.

38 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

With the introduction of The United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act in 2003 (i.e., PEPFAR I), little attention was given to TB and its impact on people living with HIV/AIDS.7 However, The Tom Lantos and Henry J. Hyde United Stated Global Leadership against HIV/ AIDS, Tuberculosis and Malaria Reauthorization Act, passed in 2008 (i.e., PEPFAR II), expanded on recommended interventions and targets for addressing tuberculosis.8 The Act called for: Sustaining or exceeding the detection of at least 70 percent of sputum smear-positive cases of tuberculosis, and treating at least 85 percent of the cases detected in countries with established USAID tuberculosis programs.

Treating 4.5 million new patients, diagnosed via sputum smear, by 2013 using Directly Observed Therapy, Short Course (DOTS) programs; this provision provides direct support for needed services, commodities, health workers, and training, and additional treatment through coordinated multilateral efforts; and

Diagnosing and treating 90,000 new MDR-TB cases by 2013, and additional treatment through coordinated multilateral efforts.

USAID total funds allocated for tuberculosis in FY 2008124

Current U.S. TB targets The Lantos-Hyde United States Government Tuberculosis Strategy supports the recommendation of sustaining or exceeding the detection of at least 70 percent of sputum smear-positive cases of tuberculosis and the successful treatment of at least 85 percent of the cases detected in countries

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 39

The GHI revised the with established USAID TB programs.127 However, the GHI revised its targets for detection and treatment of patients living with TB and MDR-TB, essentially cutting them in half. The new targets under the GHI are:

Sustaining or exceeding the detection of at least 70 percent of sputum smear-positive cases of TB and successfully treating at least 85 percent of cases detected in countries with established U.S. tuberculosis programs;

targets for detection and treatment of patients living with TB and MDRTB, essentially cutting them in half.

Treating 2.6 million new sputum smearpositive TB patients under DOTS programs by 2014, with support for needed services, commodities, health workers and training, and additional treatment through coordinated multilateral efforts; and Diagnosing and initiating treatment of at least 57,200 new MDR-TB cases by 2014 and providing additional treatment through coordinated multilateral efforts.

The strategy also states that additional detection and treatment for TB will occur through contributions to the Global Fund and that the accelerated detection and treatment of TB focuses on 25 high-burden TB countries.

TB funding The Stop TB Partnership, in its global plan for 2006-2015 outlined the gap in funding levels for efficient TB control. The estimated funding gap in 2009 was approximately US$30 billion.128 In 2010, the Stop TB Partnership published a revised global plan for 2011-2015 that takes into account the achievements since 2006. The new five-year estimate of US$47 billion includes US$37 billion for implementation and US$10 billion for research and development. The plan’s funding analysis for implementation suggests that US$23 billion can be mobilized from domestic sources, leaving a US$ 14 billion funding gap that would need to be filled by international donors in high income countries.

The overall projected funding gap for meeting all the goals and targets of the 2011-2015 plan is US$ 21 billion.

Global funding for TB control is expected to reach US$2.6 billion in 2010. Nearly 84 percent of total spending on tuberculosis control comes from national government budgets, though the relatively small amount of funding for the collaborative HIV/TB activities is channeled through national HIV programs or non-governmental organizations.31 For the 22 high-burden TB countries alone, the annual cost for TB control measures is estimated to be US$700-900 million, with most of the funding in recent years used to support DOTS programming. The gap between needed and available resources is between US$100 million and US$300 million per year, assuming current levels of aid are sustained.129 The Lantos-Hyde Act recommended that the U.S. spend up to US$4 billion between 2008 and 2013 40 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

to address tuberculosis, including MDR- and XDR-TB; this translates to about US$800 million per year. This level is substantially less than funding for HIV/AIDS and malaria. For the FY 2011 budget, the Obama Administration requested only a US$5 million increase for TB funding.130 Although TB funding has increased over time, current funding is not keeping pace with the scaleup levels authorized in the Lantos-Hyde Act, nor does it reflect the scale needed to fight TB globally.

For FY 2010, President Obama requested US$175 million and the U.S. Congress allocated US$225 million. In the FY 2011 budget request, President Obama requested US$230 million. These funding levels are well below the US$800 million per year needed to meet the goals spelled out in the LantosHyde legislation. The relatively low increase may be due to the revised and lowered targets proposed in the U.S. TB strategy document; it is unclear whether current funding requests will be sufficient to achieve these targets. Moreover, funding for the CDC’s TB program and clinical trials network would be cut by more than US$1 million, which would undermine U.S. capacity to develop better diagnostic methods, treatment or prevention tools for TB.

U.S. funding of TB, FY 1998–2010, in US$ millions131-137

USAID

FY ‘98

FY ‘99

10

15

FY ‘00 17

FY ‘01 44

FY ‘02 60

FY ‘03 65

CDC

FY ‘04

FY ‘05

FY ‘06

FY ‘07

FY ‘08

FY ‘09

FY ‘10

FY ‘11*

72

79

79

79

153

163

225

230

137

138

137

136

136

143

144

143

*(President’s Request)

Comparison between U.S. HIV/AIDS, Malaria and TB Funding, FY 2007–2008 2, 119, 138 Disease

Mortality/year (2007-2008)

Incidence/year (2007–2008)

Prevalence (2007–2008)

Funding (FY 2010)

Percentage of Budget

HIV/AIDS

2 million

2.7 million

33.4 million

US$5.5 billion

64%

Malaria

1 million

247 million

US$760 million

9%

Tuberculosis

2 million

9 million*

US$230 million

2%

2 billion

* 9 million cases (i.e., people who develop active TB disease) Funding for addressing co-infection of TB and HIV/AIDS is provided through the Office of the Global AIDS Coordinator. The level of funding is maintained at 4.3 percent of the total PEPFAR budget, increasing from US$26 million in FY 2005 to US$140 million in FY 2008. Funding in FY 2010 increased to US$160 million.21 The research and development (R&D) funding for TB is also low, given the need for new product development. In 2008, the Treatment Action Group and the Stop TB Partnership reported that the top 71 participating organizations invested a total of US$510 million in TB research and

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 41

Although TB funding development.139 This is an 8 percent increase over the 2007 total of US$474 million and a 43 percent increase over the baseline year of 2005. Although funds have increased, the investment is insufficient to produce the new knowledge and tools needed to eliminate TB and meet the Stop TB Partnership goals, which will require R&D investment of around US$2 billion per year.140

HIV/AIDS and TB co-infection Testing for and treating TB among people living with HIV/AIDS (PLWHA)

has increased over time, current funding is not keeping pace with the scale-up levels authorized in the LantosHyde Act, nor does it reflect the scale needed

to fight TB globally.

In Africa, TB is the leading cause of death among people 141 living with HIV/AIDS. Autopsies have shown that TB is underdiagnosed in 15-54 percent of people with HIV infection.142 Without proper treatment, about 90 percent of PLWHA die within months of developing TB, which is alarming given that, in 2006, a mere 1 percent of people living with HIV/AIDS were screened for TB.143 In 2006, provision of isoniazid preventive therapy (IPT) reached only about 27,000 people, or less than 0.1 percent of the estimated 33 million people infected with HIV.144 Policies on isoniazid have been developed by 84 countries, though only 25 have reported provision of the drug. Of the countries reporting, Botswana cited 70 percent of the total number of people reported to be on isoniazid in 2006.143 Screening for TB among HIV-positive people and provision of isoniazid preventive therapy more than doubled between 2007 and 2008.145 The number of HIV-positive people screened for TB increased from 0.6 million to 1.4 million between 2007 and 2008, and the number of people who were provided with IPT grew from fewer than 30,000 in 2007 to approximately 50,000 in 2008. 145 ŠŠ Despite this positive outlook, the number of people receiving services remains low. In 2005, 194,718 PLWHA were tested for TB; 18 percent of them were diagnosed with active TB In 2006, provision of isoniazid disease. In 2006, the number of PLWHA who were screened rose to 314,394; 26 percent of preventive therapy (IPT) them were diagnosed with active TB disease.

PEPFAR urges its country teams to screen reached only about 27,000 HIV patients for TB, yet as of 2008, there was people, or less than 0.1 percent no reporting on PLWHA being screened for TB.143 In the 2009 annual report to Congress, of the estimated 33 million PEPFAR reported providing treatment and care for TB among 308,719 people, mostly in Africa, people infected with HIV.144 co-infected with HIV/AIDS and TB.48

42 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Percentage of PLWHA screened for TB in select high-burden countries and globally143

Intensified TB case finding, diagnosis of TB and IPT provision among HIVpositive people, 2006 143

Notes: Percentages above the bars are the ratio of the number of people receiving the intervention to the estimated number of HIV-positive people.

Numbers below the bars are the number of countries reporting data and the percentage of total estimated HIV-positive TB cases accounted for by reporting countries.

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 43

Testing for HIV among people diagnosed with TB HIV testing of TB-infected patients has increased from about 21,800 patients in nine countries in 2002 to 687,174 patients in 112 countries in 2006—equivalent to 12 percent of notified TB cases.

The African region had the highest rate of increase—the number of TB patients tested for HIV in 11 African countries represented 57 percent of estimated HIV-positive TB cases globally; the percentage of notified cases that were tested increased from 7.5 percent to 35 percent. Most of this increase was driven by Kenya and South Africa; Malawi and Zambia also posted increased testing efforts. Outside of the African Region, the number of patients tested for HIV also increased; 56 percent of TB patients outside of Africa were tested for HIV infection in 2006.143

HIV testing and treatment in TB Patients, by WHO region, 2008145 TB Patients with Known HIV Status (thousands)

Percent of Notified TB Patients Tested for HIV

Percent of Tested TB Patients HIVPositive

HIV-Positive People Screened for TB (thousands)

HIV-Positive People Provided IPT (thousands)

Africa

636

45

46

729

26

Americas

113

49

15

48

12

22

5.4

4.1

12

0.7

357

79

3.3

205

9.2

94

4.1

18

300

0.2

152

11

7.0

90

0.7

1,374

22

26

1,384

48

Eastern Mediterranean Region Europe Southeast Asia Western Pacific Region Global

Addressing TB and HIV/AIDS co-infection In the Lantos-Hyde Act of 2008, the legislation called for an expanded focus on treating and detection of TB and HIV/AIDS co-infection. Five key provisions include: Provide diagnostic counseling and testing to individuals with HIV/AIDS for tuberculosis [including a culture diagnosis to rule out multi-drug resistant tuberculosis (MDR–TB) and extensively drug resistant tuberculosis (XDR–TB)] and provide HIV/AIDS voluntary counseling and testing to individuals with any form of tuberculosis.

Provide tuberculosis treatment to individuals receiving treatment and care for HIV/AIDS who have active tuberculosis and provide prophylactic treatment to individuals with HIV/ AIDS who also have a latent tuberculosis infection.

Link individuals with both HIV/AIDS and tuberculosis to HIV/AIDS treatment and care services, including antiretroviral therapy and cotrimoxazole therapy.

44 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Ensure that health care workers trained to diagnose, treat, and provide care for HIV/AIDS are also trained to diagnose, treat, and provide care for individuals with both HIV/AIDS and tuberculosis.

Ensure that individuals with active pulmonary tuberculosis are provided a culture diagnosis, including drug susceptibility testing to rule out MDR- and XDR–TB in areas with high prevalence of tuberculosis.

The Act also required an annual report including the following indicators:146 The number of HIV-positive individuals screened for TB and the number of HIV-positive individuals treated for TB—these are essential (required) indicators; The number and percentage of HIV-infected individuals receiving HIV/AIDS treatment or care services who are also receiving screening and treatment for tuberculosis; The number and percentage of individuals with tuberculosis who are receiving HIV/AIDS counseling and testing, and appropriate referral to HIV/AIDS services; The number and location of laboratories with the capacity to perform tuberculosis culture tests and tuberculosis drug susceptibility tests; The number and location of laboratories with the capacity to perform appropriate tests for multi-drug resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB); The number of HIV-infected individuals suspected of having tuberculosis who are provided tuberculosis culture diagnosis or tuberculosis drug susceptibility testing; and The number of people supported through U.S.-sponsored TB-HIV/AIDS co-infection programs.

According to OGAC, PEPFAR had supported TB treatment for more than 395,400 HIV-infected patients through September 2008. Current programming incorporates the following activities:147 HIV testing for people with TB and improving TB diagnosis for PLWHA; Providing HIV/AIDS prevention, treatment and care for eligible TB patients, including antiretroviral treatment, cotrimoxazole and isoniazid to prevent active TB; Controlling TB infection to prevent PLWHA from coming in direct contact with someone with active TB; Implementing WHO-recommended DOTS treatment protocol, to ensure that patients complete their TB treatment; Implementing laboratory-strengthening activities (e.g. enhanced capacity to detect both smear negative and extrapulmonary TB among PLWHA, external quality assessment, drug resistance surveillance, and rapid detection of TB drug resistance for clinical decisionmaking); and United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 45

ŠŠ Diagnosing and treating TB among HIV/AIDS and TB co-infected patients, including services to address multi-drug resistant and extensively-drug resistant TB. In July 2009, the Office of the Global AIDS Coordinator joined the World Health Organization and Stop TB Partnership and UNAIDS in releasing guidance on monitoring and evaluation of TB/HIV activities. 148 However, these guidelines are not yet reflected in the country operational guidance.

Diagnostics, prevention and treatment Options for diagnostics, prevention and treatment New tools to diagnose, treat, and prevent TB are needed to meet the Stop TB Partnership and WHO goals to reduce the 1990 levels of TB incidence and death by 50 percent by 2015, and to eliminate TB as a public health threat by 2050.149 Scale up is needed in basic, applied and operational research, and in the development of better tools to prevent, diagnose and cure TB.140 The current TB vaccine, Bacille Calmette-Guerin (BCG), was developed in 1921.150 It has several limitations: relatively low effectiveness against adult pulmonary tuberculosis, potential interference with the tuberculin test reactivity, a protective effect of 60-80 percent in northern regions but lower toward the equator, effective prevention for only about 15 years, and it cannot be administered to HIV-positive populations because it is a live virus vaccine and the risk of infection is too great.151 152 The lack of appropriate diagnostic tools and laboratory facilities leads to many patients being diagnosed on the basis of clinical suspicion and, if available, chest X-rays.128 Diagnosis of TB relies on chest X-rays, a tuberculin skin test or blood tests, as well as microscopic examination of a sputum culture. The sputum smear test, more than a century old, is the only widely available diagnostic tool in most developing countries; assessment requires training. Sensitivity is only 40-60 percent, though sensitivity can fall to 20 percent for HIV-positive patients. Diagnosis using a TB culture grown under controlled laboratory conditions has sensitivity close to 100 percent, but takes 4-6 weeks and is performed only in reference centers or larger hospitals, which may be limited to major cities. The absence of convenient diagnostic tests for latent infection that accurately predict the risk of progression to active TB, especially in HIV-infected patients, constrains the implementation of effective and rational preventive therapy strategies.

In 2008, diagnostic testing for drug susceptibility, or DST, among new cases of TB was almost entirely confined to the European region and the Americas (conducted in 13 and 17 percent of cases, respectively); DST was conducted in less than 10 percent of cases in all other regions.145 The increase in multi-drug resistant tuberculosis in Eastern Europe, Russia and China has stretched scant local financial resources, particularly with regard to high-cost second-line drug treatment.149 The drugs used to treat TB and MDR-TB are more than 30 years old; the last drug developed for TB was rifampicin, which first came into wide use in 1971-72. The DOTS strategy was developed to ensure that TB patients took their medication and has become a cost-effective treatment option for more than 17.1 million patients between 1995 and 2003. The TB treatment regimen is a 6-8 46 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

month course for drug-susceptible TB; the course for multi-drug resistant TB is nearly twice that duration.153 Yet, many TB patients stop using their medication for a variety of reasons; a shorter and more effective regimen would reduce the chance of non-adherence. Furthermore, TB treatments are difficult to take with some HIV medication.154 Governments and NGOs can apply for funding from the Green Light Committee (GLC) Initiative, created in 2000 by the WHO to fund access to TB medication.155 In 2009, more than 19,000 MDR-TB patients were enrolled in programs funded by the GLC.

U.S. support of research and development The Lantos-Hyde Act of 2008 did not include specific requirements for research and development for new tools and technologies and diagnostics.22 However, it did ask that the U.S. Government include the following information in its annual report: “a description of research efforts and clinical trials to develop new tools to combat tuberculosis, including diagnostics, drugs, and vaccines supported by United States bilateral assistance.”

The 2008 annual report to Congress on the U.S. Government research activities indicated that increased resources were used to accelerate the development of new and improved TB diagnostics and support research on anti-TB drugs.156 The strategy was released in March 2010, so much of this policy still needs to be tested in practice and funding for new tools and technologies must be monitored. The U.S. Policy on Research and Development for TB highlighted:157 The U.S. commits to help countries conduct field tests of new technologies and integrate these technologies into existing programs. Policy development and capacity building will be supported to accelerate introduction of these new tools and to ensure their appropriate use. Examples include the use of bleach to enhance smear microscopy, fluorescent microscopy and rapid methods to detect TB and drug-resistant TB. The strategy promotes research and innovation on new candidate diagnostics, drugs, vaccines and alternative models for DOTS, which are in the pipeline. These new technologies have the potential to revolutionize how TB is diagnosed, treated and prevented. In addition, new applications of existing tools have the potential to enhance ability to detect and manage cases.

The U.S. will invest in new tools and approaches that are less labor intensive, more costeffective, of greater efficacy and can be delivered closer to the patients, thereby improving case detection and treatment success rates. Building upon NIH’s comparative advantage to support fundamental science, new product development, and early stage clinical trials, funding for research under the Reauthorization Act will support subsequent phases of research as relevant tools become ready for field evaluations.

In addition to new tools and approaches, the U.S. and its partners will play a critical role in assessing program performance, analyzing operational barriers and developing and testing approaches to overcome constraints to program implementation. Priority will be given to United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 47

operations research on key issues that inhibit implementation and scale up of services, and will evaluate novel and innovative ways to improve the impact of TB diagnosis, treatment and control interventions. Through this constant reevaluation of implementation efforts, barriers can be addressed rapidly and new ideas can move from testing to implementation.

Slow progress in implementation of the Stop TB strategy USAID’s new TB strategy was launched in March 2010. Despite USAID’s previous progress and achievements, implementation of the strategy has been slower than expected. Case detection of TB is lagging in Europe and Africa in particular, where rates are 51 percent and 47 percent, respectively.156 While overall treatment success in DOTS programs is 85 percent (2006 cohort), regional disparities reveal low rates of treatment success in Europe (70 percent) and Africa (75 percent), due in part to multi-drug resistant TB and TB-HIV/AIDS co-infection. The progress made in Asia is also fragile, and programs require continued strengthening. Efforts need to be accelerated to engage the private sector, treat MDR-TB, and scale up TB-HIV/AIDS collaborative activities.

Globally, rates of case detection have stagnated since 2006; renewed efforts to increase case-finding are needed to keep pace with Stop TB Partnership’s Global Plan to Stop TB (Global Plan) milestones.

The largest gap between estimated case detection rates in practice and the Global Plan milestones is in the Africa Region; a gap is also evident in the Western Pacific Region, where case detection rates have remained stable since 2005.145 The case detection rate has been increasing in the Eastern Mediterranean and Southeast Asia regions, and this rate of progress needs to be maintained to keep pace with the Global Plan. The European Region is the only region where current estimates of the case detection rate exceed Global Plan milestones.145

Conclusion Since TB’s identification in 1882, there has been much progress in controlling this disease, yet there have also been setbacks.

The epidemiology of the disease is known, drug regimes to treat TB have improved and there are diagnostic and preventive measures available at relatively low cost.

However, TB and its co-infection with HIV remain a health threat in many parts of the world.

The Stop TB Partnership Global Plan 20112015 posits that full implementation of its research and development component can result in achievements in diagnostics and treatment. It estimates that by 2015

Despite USAID’s previous progress and achievements, implementation of the Stop TB strategy has been slower than expected. Case detection of TB is lagging in Europe and Africa in particular, where rates are 51 percent and 47 percent, respectively.156

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U.S. Government’s there will be a new four-month TB regimen, including one new drug approved by regulatory authorities for sensitive TB and for the treatment of drug-resistant TB. The Global Plan also estimates that by 2015, four new TB vaccine candidates will have entered Phase III clinical trials for safety and efficacy. However, to achieve these expectations, it is essential to mobilize needed resources.

detection and treatment targets for TB have already been reduced from those recommended in the Lantos-Hyde

Increased funding and attention for TB, integration of cotrimoxazole and isoniazid preventative therapy legislation with other health interventions (in particular with HIV/AIDS), scaling up of treatment efforts and the development of better tools are crucial next steps. A particular concern is that the U.S. Government’s detection and treatment targets for TB have already been reduced from those recommended in the Lantos-Hyde legislation. These gaps and the relative lack of focus on TB are of particular concern, as multi- and extensively-drug resistant strains of the bacteria are propagated in increasing numbers of countries.

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U.S. Global Malaria Policy

M

alaria transmission occurs in tropical regions around the world. Difficulties diagnosing malaria are obstacles to

counting cases and deaths; in 2008, there were an estimated 243 million cases of malaria and 863, 000 deaths, mostly in Africa.158-162 The number of malaria cases and deaths is an estimate—the reported numbers may be high due to the assumption that any fever is malaria or low if attributed to other co-infections or not reported to health authorities (about 10 percent are reported).

The majority of malaria deaths occur among young children. However, between 40 percent and 80 percent of cases (illness that does not lead to death) occur in adults.

Pregnant women are particularly vulnerable to malaria, which can result in both maternal and fetal death. Pregnancy decreases immunity to malaria and increases susceptibility to severe anemia and death. Maternal malaria also increases the risk of miscarriage, stillbirth, premature birth, and low birth weight.

Malaria in Africa The WHO estimates that 90 percent of malaria cases occur in sub-Saharan Africa, where, in many countries, nearly the entire population is at risk for contracting the disease.71 Ninety-five percent of African malaria cases are caused by Plasmodium falciparum, the most deadly of the four types of malaria-causing parasites. Efforts to eradicate malaria originally began in 1955 with the Global Malaria Eradication Program, which called for dichlorodiphenyltrichloroethane (DDT) application to interrupt transmission.163 The program failed to eradicate malaria. Recent efforts call for a scale up of proven short-term interventions that would reduce malaria mortality and morbidity. Though the focus has been on high-burden countries, people living in areas of low transmission are susceptible to malaria, particularly given their bodies’ lack of exposure to the parasite.

To address this disease in sub-Saharan Africa, the President’s Malaria Initiative for 2009-2014 calls for implementation of “long-lasting insecticide-treated nets (LLINs), indoor residual spraying (IRS) with insecticides, intermittent preventative treatment of pregnant women (IPTp) where appropriate, and treatment with artemisininbased combination therapies (ACTs), ideally based on a laboratory diagnosis of malaria.”164

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U.S. Government response to malaria In 2005, the President’s Malaria Initiative (PMI) was created to coordinate and expand the United States Government’s response to malaria, with the goal of reducing malaria worldwide by 50 percent. The creation of PMI was a significant expansion of existing malaria programs. Allocations for malaria are made to PMI via the PEPFAR initiative; PMI determines the U.S. contribution to the malaria budgets in a set of focus countries. The Lantos-Hyde Leadership Act against AIDS, TB and Malaria of 2008, included malaria in its mandate along with significant funding for HIV/AIDS. The legislation formally established a coordinator and expanded language on programs and services.

The focus on malaria has expanded beyond the initial PMI focus countries, as the U.S. has malaria programs in many other countries. The Lantos-Hyde Act called for a comprehensive five-year strategy that:8, 22 Strengthens the capacity of the United States to be an effective leader of international efforts to reduce malaria burden; Maintains sufficient flexibility and remains responsive to the ever-changing nature of the global malaria challenge; Includes specific objectives and multisectoral approaches and strategies to reduce the prevalence, mortality, incidence, and spread of malaria; Describes how this strategy would contribute to the United States’ overall global health and development goals; Clearly explains how outlined activities will interact with other United States Government global health activities, including the five-year global AIDS strategy required under this Act; Expands public-private partnerships and leverage of resources; Coordinates among relevant federal agencies to maximize human and financial resources and to reduce duplication among these agencies, foreign governments, and international organizations; Coordinates with other international entities, including the Global Fund; Maximizes United States capabilities in the areas of technical assistance, training and research, including vaccine research; and Establishes priorities and selection criteria for the distribution of resources based on factors such as: yy The size and demographics of the population with malaria; yy The needs of that population; yy The country’s existing infrastructure; and yy T he ability to closely coordinate United States Government efforts with national malaria control plans of partner countries.

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As required by the Lantos-Hyde Act of 2008, the U.S. Government recently released its five year strategy on malaria. This strategy is linked to the U.S. Global Health Initiative. The United States malaria strategy 2009-2014 aims to: Integrate malaria activities with programs for maternal and child health, HIV/AIDS, neglected tropical diseases, and tuberculosis; Build the capacity of focus country health systems and workforces, with focus on supply chain management, disease surveillance and reporting, monitoring and evaluation, and laboratory diagnostic services; Support development of national malaria control strategies; and Ensure a women-centered approach to malaria prevention and treatment activities, both in health facilities and in the community.164 The strategy also calls for increased coordination of malaria with HIV/AIDS service delivery, to support the greater GHI agenda. To do this, programming will be funneled though antenatal clinics (ANCs) with the aim of preventing mother-to-child transmission.165 This approach is not particularly new, as PMI has focused on integrating malaria treatment though ANCs. There was a consensus in 2005 upon the launch of PMI that, as a member of Roll Back Malaria (RBM), it would not “attribute increased coverage of malaria interventions or reductions in malaria morbidity and mortality to PMI-supported efforts alone.”164 Results would be a combined effort of various stakeholders at the national and international level.

U.S. funding for malaria PMI began with three focus countries in 2005 and has since expanded to 15. Focus countries now include: Angola, Tanzania, Uganda, Malawi, Mozambique, Rwanda, Senegal, Benin, Ethiopia, Ghana, Kenya, Liberia, Madagascar, Mali and Zambia. In 2010, a total of US$500 million is expected to be disbursed to these countries—a US$200 million or 60 percent increase from FY 2009.164 This increase in funding is not surprising in the context of high donor expectations and enthusiasm for malaria control, elimination and even eradication. Programming to prevent or treat malaria is frequently cited as highly cost-effective and having the second greatest impact on health in subSaharan Africa (after childhood immunization).166 The President’s Malaria Initiative is administered and implemented by the U.S. Agency for International Development (USAID), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS). The Lantos-Hyde Leadership Act against AIDS, TB and Malaria of 2008 included a specific funding recommendation for malaria of US$5 billion over five years, thereby significantly increasing the United States resource commitment to malaria.8, 22

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Funding need versus funding disbursements167

Although overall funding has increased, it is unclear how funding allocation decisions by country are made. PMI does not state whether differential funding stems from differences in need, disease prevalence, or some other factor.

President’s Malaria Initiative funding, 2006–2010168

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President’s Malaria Initiative country-level funding, 2009

U.S goals and targets for malaria PMI states that its goal is to reduce malaria-related deaths by 50 percent in its 15 focus countries.164 This is a formidable challenge; for most of these countries, WHO reports little progress in malaria reduction for the period of 2000-2008.71 Some countries, such as Zambia, have seen a decline in malaria deaths for some time, while others, such as Benin and Malawi, have seen an increase in the number of deaths from malaria over the years.

To reach its 50 percent goal, PMI states it will expand coverage of effective prevention and treatment interventions to reach 85 percent of children under five and pregnant women by implementing WHO’s recommended guidelines.169 In all 15 target countries, PMI seeks to achieve the following: More than 90 percent of households with a pregnant woman and/or children under five will own at least one insecticide-treated bednet (ITN); 85 percent of children under five will have slept under an ITN the previous night; 85 percent of pregnant women will have slept under an ITN the previous night; 85 percent of houses in geographic areas targeted for indoor residual spraying (IRS) will have been sprayed; 85 percent of pregnant women and children under five will have slept under an ITN the previous night or in a house that has been protected by IRS; 85 percent of women who have completed a pregnancy in the last two years will have received two or more doses of IPTp during pregnancy; 54 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

85 percent of governmental health facilities will have artemisinin-based combination therapies (ACTs) available for treatment of uncomplicated malaria; 85 percent of children under five with suspected malaria will have received ACT treatment within 24 hours of onset of symptoms.

WHO guidelines To reduce the global burden of malaria, the WHO recommends indoor residual spraying to kill mosquitoes, use of insecticide-treated nets to prevent mosquito bites, intermittent preventative treatment (IPTp) with doses of sulfadoxine–pyrimethamine (SP) during pregnancy to periodically clear the placenta of parasites, and prompt treatment with artemisinin-based combination therapies (ACTs).170 The WHO recognizes that in the case of latter, there is a growing risk for parasite resistance to these drugs. To tackle this, the WHO has recommended that artemisinin should not be used as a monotherapy, which could increase development of resistance to this drug.171 The WHO also encourages countries to monitor closely use of these drugs, patient response and the development of resistance. However, many countries lack the capacity to comply with the WHO’s scientific protocols for monitoring and testing.71 To reduce the potential for drug resistance, the WHO has stressed the importance of prevention. Yet, the prevention strategies also have implications for the development of resistance. Indoor spraying, for example, may lead to the development of insecticide resistance among the mosquito vectors.

Thus, monitoring both drug resistance and insecticide resistance is essential, though guidance for countries on implementing these surveillance measures is limited.172

Challenges Determining the true burden of malaria is challenging—WHO reports a general lack of data on both the burden of malaria and effectiveness of interventions. Malaria is typically measured by observing the number of cases (often including misdiagnosed cases of generalized fever) and deaths each year. Some critics note that the figure of 3.2 billion people around the world at risk of The spread of drug resistance contracting malaria may be an overestimate.173, 174 Academics note that observational methods may to malaria has grown, not accurately reflect transmission rates and that serological tools, which may be more effective, are particularly in Asia and the seldom available in the field.175 The WHO depends on nationally reported data, which are often inconsistent—for example, there were two different sets of data for malaria deaths in 2008 in Mozambique. When data are available, country statistics on malaria may be skewed because only certain regions were surveyed.176

Americas and has become of particular concern in malaria control.164

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Although PMI cites the Collecting accurate information on the number of cases of malaria in a given country is dependent upon their health system’s capacity for diagnosis. If countries are unable to establish and maintain accessible laboratories for accurate malaria testing, reliable data collection and assessment of progress will be challenging.

number of ITNs it has distributed, it is unclear how many nets are actually used properly.

Drug resistance to malaria has spread, particularly in Asia and the Americas, and has become of particular concern for malaria control efforts.164 The next challenge will be “to sustain routine monitoring of antimalarial drug resistance to detect early any loss in efficacy of the first- and second-line drugs.”164 A large contributor to resistance is the market of counterfeit and substandard drugs, which in turn drives up treatment costs because resistant strains are more expensive to treat. This is an issue of particular concern in Southeast Asia.177–180

PMI technical strategy for prevention Existing NIH, CDC and Department of Defense efforts to develop and test new malaria prevention and control tools, (such as new antimalarial drugs, insecticides and malaria vaccines) and to train qualified malariologists, entomologists, and malaria researchers will continue under those agencies’ intra- and extramural research programs. These efforts will complement the implementation research to be carried out under the Lantos-Hyde Act.164

Insecticide-treated nets (ITNs) “PMI has focused on scaling up ITN coverage in all 15 focus countries, targeting the most vulnerable populations by delivering ITNs through immunization or health campaigns, antenatal and child health clinics, and the commercial sector; by procuring and distributing long-lasting ITNs; and by educating at-risk populations about the benefits and proper use of ITNs.”181 ITN procurement and distribution constitute the largest PMI allocation of funding in each focus country.182 However, although PMI cites the number of ITNs it has distributed, it is unclear how many nets are actually used properly. According to the annual report, the percentage of women who slept under an ITN the previous night did not exceed 25 percent in the countries surveyed (Angola, Uganda, Tanzania, Malawi, Mozambique, Rwanda and Zambia).182 PMI has sought to ensure that at least 85 percent of women in each country sleep under ITNs.169 In addition, PMI does not appear to have a policy related to ITN standards, retreatment or replacement in beneficiary households. Studies that collected ITNs two years after initial distribution found that the bednets had an average of 40 holes and that the vast majority of nets had lost their insecticide potency.183 There is no PMI guidance on household maintenance of bednets or when new ITNs should be purchased.

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Malaria in pregnancy Thirty million pregnant African women living in malaria-endemic regions are exposed to malaria every year. Intermittent preventative treatment (IPTp) is one strategy to combat malaria during pregnancy. PMI has followed WHO recommendations for a three-pronged strategy including IPTp, ITNs and effective treatment of malaria among women.164 IPTp involves administering the anti-malarial drug sulfadoxine-pyrimethamine (SP) to pregnant women beginning in the second trimester, but does not recommend this strategy for pregnant women living in areas with low levels of transmission. According to the Lantos-Hyde malaria strategy, “Pregnant women, along with children under five are the two groups most vulnerable to the effects of malaria and, consequently are the targets of most malaria prevention measures.”164 This woman-centered approach is consistent with the Global Health Initiative.

IPTp entails administering two full doses of an antimalarial drug during pregnancy. Three randomized clinical trials conducted in Kenya and Malawi in the late 1990s have made the case for the intermittent use of SP for pregnant women.184-186 Since then, resistance to SP has quickly spread and many fear that this technique is no longer effective.176 Other drugs, such as ACTs, can be used, however data on their safety and efficacy are scarce. The inclusion of pregnant mothers in clinical trials has raised ethical concerns regarding their well-being and the well-being of the fetus. As a result, Nosten et al. have concluded that there is “no antimalarial drug that can reliably and safely protect pregnant women from malaria parasites.”187 In the absence of another strategy, IPTp treatment with SP continues to be funneled though antenatal clinics (ANCs). While ANC attendance in sub-Saharan Africa is reported to be more than 70 percent, IPTp coverage remains low.188 In other words, simply attending an antenatal clinic does not guarantee IPTp treatment. In addition to ensuring coverage for women who seek ANC, providing coverage for women who have limited or no access to ANC’s presents an even greater challenge. Communitybased programs have had some success in delivering IPTp programs to pregnant women, though there are concerns that such programs will inadvertently cause a drop in ANC attendance.189 Yet another concern is that IPTp is not being coupled with ITN use.176 Additional research is needed to better understand the health-seeking behavior of the women affected by malaria and barriers to care experienced by ANCs.

IPT for infants (IPTi) In its January 2009 Technical Guidance, PMI had not yet officially endorsed IPT as a method for prevention in infants. Like, IPTp, IPTi utilizes SP as an antimalarial drug that must be administered three times during infancy at the time of routine vaccinations.164 In April 2009, a WHO technical report stated that the strategy was beneficial in areas where SP remains effective against P. falciparum parasites. The report endorsed the implementation of IPTi albeit with conditions, such as continuous surveillance and ensuring that IPTi is not implemented in low transmission areas.190 New research suggests that there may be some potential benefits to IPTi in certain areas, e.g., protection

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against clinical malaria for 35 days after the administration of each dose.191-194 PMI has yet to release new guidance in light of WHO’s new recommendations.

Drug resistance and quality In its 2009 Technical Guidance, PMI notes that resistance to ACTs is spreading and aims to: … support well-functioning antimalarial drug resistance surveillance networks in each country in the region; establish national systems to monitor the quality of antimalarial drugs as a means of preventing the introduction and dissemination of substandard or counterfeit drugs, which contribute to increased drug resistance; and contribute to a further reduction in the level of transmission of P. falciparum malaria and the number of reported cases in the Greater Mekong Region and the Amazon Basin, with a goal of elimination of malaria in these areas by 2020.164 Through USAID, PMI funds research and development at the Medicines for Malaria venture, in conjunction with other donors.165 In addition, PMI works with countries to ensure that available drugs are not counterfeit.165 Resistance to malaria drugs was first observed on the Thai-Cambodian border—where chloroquine was found to be less effective in fighting the disease than it had previously been.195 Resistance to chloroquine is already widespread across sub-Saharan Africa; ACT resistance is a looming threat.

There has been no major push for the development of new drugs, though the National Institutes of Health (NIH) and the Gates Foundation continue efforts to develop new treatment options.163 Drug quality is yet another challenge. A recent USAID report found that one-third of antimalarial drugs sampled in Madagascar, Senegal, and Uganda (all PMI countries) were of substandard quality.196 More guidance is needed on how to avoid dispensing these poor quality anti-malarials.

PMI technical strategy for diagnosis and treatment Home-based management of malaria Home-based treatment of malaria has been promoted widely by WHO and Roll Back Malaria (RBM).170 PMI has followed suit, investing in “training and supervision of health workers, logistical support for home-based management of fever (HBMF), ACT procurement and quality testing to improve malaria case management.”197 Evidence for home-based treatment is limited and its impact on malaria-associated morbidity and mortality is limited.198 Though the strategy is hailed as a means of improving access, there are concerns that such a non-formal approach can possibly lead to misdiagnosis and therefore increased drug resistance. Misdiagnosis is quite common; a review highlighted that health professionals have overestimated malaria in five PMI countries: overestimation percentages ranged from 28 percent in Tanzania to 85 percent in Malawi.199 Experts question whether caregivers can do a better job of providing appropriate care.200 A randomized controlled trial found that most anti-malarial 58 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

treatments given in home settings in urban, low transmission areas were in fact given for illnesses other than malaria, though the scenario may differ in a region with high prevalence.201 Another concern is that households and communities may not have the capacity to oversee proper drug administration; poor compliance can also lead to drug resistance.202 One study that assessed the effectiveness of such interventions found that 80 percent of caregivers reported that they had complied fully with the treatment. Though this figure was not verified via laboratory follow-up to assess plasma lumefantrine levels, the study suggests that home-based treatment with ACTs can in fact work.203 Given these mixed results, more studies are needed to assess the impact of home-based strategies and their cost effectiveness.202 Experts also emphasize that programs and program assessments must consider transmission rates, urban versus rural settings, epidemiology of the disease in the region, community capacity, and drug resistance factors when implementing home-based programs.198

Rapid diagnostic testing (RDT) PMI supports RDTs to confirm malaria cases and avoid misdiagnosis, but also recognizes that RDTs are not without fault and can be problematic for a variety of reasons. Diagnostic capacity at the country level needs to be improved to avoid misdiagnosis and possible development of drug resistance. To that end, a joint PMI and PEPFAR effort is underway to strengthen laboratory diagnosis of malaria and greater access to testing.165 RDT effectiveness is dependent on several factors, including the environment in which they are used, the temperature at which they are stored, the brand being used, and the sensitivity of the equipment to the parasite. Effectiveness studies have thus reported variable results. For example, one study conducted in Uganda found RDTs to be the “best diagnostic choice in Africa,” while another study found problems with RDT quality in Tanzania.204, 205 Though traditional microscopy is the gold standard for malaria diagnosis, RDT kits can provide greater access, deliver timely results, are relatively easy to use and do not require extensive training.206 On the other hand, cost per test may exceed that of microscopy, particularly in areas of high malaria prevalence.207, 208 Other challenges include a short shelf life, distribution and storage costs and lower sensitivity than labbased tests. RDTs do not necessarily decrease over-diagnosis of malaria, but have the potential to reduce overtreatment at a moderate cost increase.209, 210 Additional research is needed to provide more clear and robust evidence for RDT use and effectiveness.

PMI results: assessing impact The PMI’s 15 focus countries were addressed in three phases: Round 1 (2006): Angola, Tanzania, Uganda Round 2 (2007): Malawi, Mozambique, Rwanda, Senegal Round 3 (2008): Benin, Ethiopia, Ghana, Kenya, Liberia, Madagascar, Mali, Zambia

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Better indicators are Due to the fairly recent launch of PMI (especially for needed for monitoring Round 3 countries, which were incorporated in 2008), it is difficult to assess results. Overall, the WHO reports and evaluation to that in 2006-2008, the reported numbers of malaria admissions and deaths worldwide were 70 percent inform progress and lower than they were in 2001-2002.71 Round 1 countries reassess program Angola and Uganda, launched in 2006 (PMI’s first year of operation), both saw an increase in the number of design/interventions. cases of malaria, but a decline in the number of deaths.

In Tanzania, cases and deaths have been decreasing steadily since 2003, although data are scarce. Round 2 countries also witnessed a decrease in deaths between the years of 2007 and 2008. However, this drop may not be attributable to PMI programs, which only launched in those countries in 2007. Round 3 countries, launched in 2008, are even more difficult to assess as data have yet to be released for 2009. Nonetheless, PMI has cited evidence from Zambia dating back to 2006-2008 as part of its success when in fact PMI programming there only started in 2008.176, 211 The true effects of malaria interventions remain unclear, as statistics on cases and deaths do not necessarily reflect intervention success. It is possible that the dramatic drop in malaria cases can be attributed to more accurate diagnosis, rather than labeling any fever as “malaria.” Similarly, rates of ITN ownership do not necessarily reflect how, and how often, these nets are used in households. In Tanzania, a 2007-2008 survey found that despite increased rates of ITN ownership, only 27 percent of pregnant women and 26 percent of children under five actually slept underneath an ITN the night before the survey.212 To increase surveillance, PMI has teamed with the Ministry of Health for the first HIV/AIDS and Malaria Indicator Survey. Though the results have yet to be released, this is an important step for monitoring and evaluating malaria and HIV/AIDS interventions in Tanzania.

Other PMI countries, such as Zambia and Senegal, also have low rates of ITN use among children under five despite relatively high ownership rates. Zambia ITN ownership is estimated at about 62 percent, while use among children under five is at 41 percent. In Senegal the rates are 63 and 31 percent, respectively.71 Though the gap between ownership and use is not as stark in other PMI countries, PMI data on how many nets were distributed in any given country do not necessarily reflect the reality on the ground. The same can be said for other interventions e.g., simply dispensing malaria drugs to ANCs does not guarantee that pregnant women will obtain access to them.176 Better indicators are needed for monitoring and evaluation to inform progress and reassess program design/ interventions.

Conclusion The 2010 six-year strategy on malaria outlines how the U.S. Government will achieve the goals outlined in the Lantos-Hyde Act of 2008. As the strategy is new, how it translates operationally remains to be seen, but specific gaps in policy need to be addressed. First, PMI needs to offer more guidance 60 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

on counterfeit and sub-standard drugs and ANC accessibility for women seeking IPTp. Second, PMI should assess its performance based on ITN use, rather than procurement and distribution.

Guidance on how often ITNs should be replaced and how they should be used would also be helpful.

Since most of PMI policy is in line with WHO policy on malaria, PMI should consider implementing IPTi for infants, as outlined by the WHO. As progress is made in all 15 countries, more concrete data should be collected and shared to assist these countries in improving their programs. It would also be helpful if PMI released information on how funding allocations are made. Though it may be too early to assess the true impact of PMI’s programming on the ground, PMI should nonetheless continue to release monitoring and evaluation guidelines. Until newer and more effective strategies are developed by experts, PMI can improve its already-existing programs on the ground and assess its performance based on solid metrics and existing guidelines.

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U.S. Maternal, Newborn, Child and Reproducitive Health Policies

M

aternal and child mortality are decreasing globally, and more women have access to reproductive health services than in the past. Yet despite many successful initiatives,

programs and interventions, the maternal and child health situation in many developing countries is still off track with regard to the targets set out in Millennium Development Goals (MDG) 4 (reduce child mortality) and 5 (improve maternal health).213 Most maternal and child deaths are preventable;

95 percent of all maternal and child deaths occur in the developing world.213

Maternal health A new report released jointly by the World Health Organization (WHO), United Nations Children’s Fund (UNICEF), the United Nations Population Fund (UNFPA) and the World Bank estimates that the number of women dying due to complications during pregnancy and childbirth has decreased by 34 percent from an estimated 546,000 in 1990 to 358,000 in 2008.214 The Institute for Health Metrics and Evaluation also published a study indicating that maternal deaths have dropped by 35 percent between 1980 and 2008, to 343,000. Dr. Margaret Chan, the Director-General of the WHO, agrees that a global reduction in maternal deaths is encouraging, but underscores that 1,000 women still die each day from pregnancy-related causes and that more needs to be done to achieve the MDG 5 targets. Women are at the greatest risk of death within the first 48 hours after delivery and between 25 and 45 percent of all neonatal deaths occur during the first 24 hours of life.215, 216 The report says that although progress is notable, the annual rate of decline is less than half of what is needed to achieve the MDG 5 target of reducing the 1990 maternal mortality ratio by 75 percent by 2015.214 Globally, 215 million women are still in need of safe, modern and effective family planning methods.217 These women not only lack contraceptives, but also information and reproductive health services and, in some cases, the support of their husbands or communities.218 Satisfying the unmet need for contraceptive services in developing countries would avert roughly 50 million unintended pregnancies annually and would save the lives of 251,000 women and 1.7 million newborns. Fulfilling the unmet need for modern family planning methods would cost US$3.6 billion (US 2008 dollars), in addition to the current spending of US$3.1 billion—for a total of US$6.7 billion annually.

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1,000 women still die each day from pregnancyrelated causes. Globally, 215 million women are still in need of safe, modern and effective family planning methods.217

Major causes of maternal deaths, 1997–2007

Newborn and child health The decline in under-five mortality continues. Estimates indicate that the total number of deaths among children has decreased globally from 12.4 million per year in 1990 to 8.1 million in 2009, and the child mortality rate has dropped from 89 deaths per 1,000 live births to 60 deaths per 1,000 live births.219 Of the current 8.1 million deaths, most are the result of preventable and treatable causes, such as pneumonia and diarrhea. Nearly 70 percent of deaths occur in the first year of the child’s life—3.7 million deaths are in the first month.215, 220 Mortality in children under five is concentrated in sub-Saharan Africa and South Asia (approximately 50 and 30 percent, respectively).221 Maternal and newborn mortality are similarly concentrated in those regions. About half of global under-five deaths occurred in just five countries in 2009: India, Nigeria, Democratic Republic of Congo, Pakistan and China.219 In 2009, the top 5 countries with the highest rate of under-five mortality were Afghanistan (257 per 1,000 live births), Angola (220 per 1,000), Chad (209 per 1,000), Somalia (200 per 1,000) and Democratic Republic of Congo (199 per 1,000).

Despite the progress in reducing under-five mortality between 2000 and 2009, many countries have not had sufficient progress to achieve the MDG 4 target—to reduce 1990 under-five mortality by two-thirds by 2015.221 Progress has been particularly slow in sub-Saharan Africa, South Asia and Oceania. The poorest performing countries with regard to child mortality are: Botswana, Swaziland, Zimbabwe, Lesotho, Kenya, Congo, Equatorial Guinea, South Africa, Cameroon and Chad. The worst performers in maternal mortality were: Sierra Leone, Niger, Chad, Angola, Somalia, Rwanda, Liberia, Burundi, Malawi, Guinea-Bissau, Nigeria and Democratic Republic of Congo.221 United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 63

The regional analyses might, however, sometimes be misleading. Malawi and Eritrea were two of the best performers at country level (based on the average annual rate of reduction among countries with under-five mortality of 40 or higher); both have consistently achieved annual rates of reduction of under-five mortality of 4.5 percent or higher. Additionally, Niger, Malawi, Mozambique, and Ethiopia have achieved absolute reductions of more than 100 per 1,000 live births since 1990. These countries are providing proof that MDG4 is achievable, even in the poorest environments.221 The poorest performers in under-five mortality are countries with a continuous intra-country and/or inter-country conflict.

Global causes of child death, 2008

Family planning and reproductive health Family planning and reproductive health (FP/RH) are an important part of any maternal health effort.222 Improved RH outcomes—lower fertility rates, improved pregnancy outcomes, and lower sexually-transmitted infections (STIs)—have broader individual, family, and societal benefits, including a healthier and more productive work force, greater financial and other resources for each child in smaller families, and a means for young women to delay childbearing until they have achieved educational and other goals.217 Many studies have demonstrated that poor RH outcomes—early pregnancies, unintended pregnancies, excess fertility and poorly managed obstetric complications— adversely affect the opportunities for poor women and their families to escape poverty.223 Access to family planning and reproductive health is critical to the health of women and children worldwide. Improving access to family planning and reproductive health services can help prevent 64 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Access to family planning maternal deaths and reduce unintended pregnancies.

According to the WHO, 20 million women experience unsafe abortion worldwide each year; 18.5 million of which occur in developing countries. Unsafe abortion results in about 68,000 deaths, all in the developing world.224 Untold millions suffer serious injuries and physical as well as mental disabilities. WHO states that unsafe abortion is one of the most easily preventable and treatable causes of maternal mortality and morbidity.224

and reproductive health is critical to the health of women and children worldwide.

Safe pregnancy and childbirth, healthy children and the ability to control one’s fertility are important goals for families and key indicators of good health. To meet these goals, women need access to health services before, during and after birth. In addition to care for current pregnancies, women also need family planning services to space or prevent subsequent pregnancies.225 In the past, the global health community has been unable to integrate maternal, newborn and child health successfully and comprehensively.226 The inability to integrate services and provide continuum of care has led to some missed opportunities, particularly in sub-Saharan Africa and specifically in the areas of intermittent preventative treatment of malaria, post-natal care both for women and neonates, and PMTCT.227

Funding for Maternal, newborn, child and reproductive health (MNCRH) Global Need To achieve MDG 4 and 5 by 2015, an estimated US$30 billion is needed, with costs increasing annually to US$5.5 billion in 2015.229 This estimate was calculated by the High Level Task Force on Innovative International Financing for Health Systems (HLTF) and endorsed by the Partnership for Maternal, Newborn and Child Health (PMNCH), a global alliance of more than 3,000 organizations working on maternal, newborn and child health. This estimate includes an additional US$11.8 billion for maternal health, US$8.4 billion for family planning, US$2.5 billion for the management of childhood illnesses, and US$6.3 billion for immunization.230 This investment would avert up to 322,000 maternal deaths, four million child and infant deaths, and 11 million unwanted births.231 The Global Strategy for Women’s and Children’s Health indicates that the funding gap for the poverty/hunger and health MDGs (MDGs 1c, 4, 5 and 6) among the 49 lowest-income countries ranges from US$26 billion per year in 2011 (US$19 per capita) to US$42 billion in 2015 (US$27 per capita) as countries scale up their programs.228

Global expenditures In 2007, total official development assistance for maternal, newborn and child health was US$4.1 billion. This represents a 16 percent increase in official development assistance (ODA) funding from 2006 and is nearly double the funding levels in 2003. Family planning, however, received less United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 65

Over the past decade, funding in 2007 than 2003. In 2007, funding for maternal, newborn and child health combined represented just under one-third (31 percent) of total ODA spending on health.221

U.S. funding

U.S. funding for MNCRH has been stagnant, only with a slight increase in recent years.232, 233

Over the past decade, U.S. funding for MNCRH has been stagnant, with a slight increase in recent years.232, 233 The FY 2011 budget request would increase spending from FY 2010’s US$549 million to US$900 million for MNCRH and nutrition, which represents 6 percent of the overall Global Health Initiative funding. This low level of funding by the U.S. contributes to the gap between global need and global spending on MNCRH. USAID organizes its activities for maternal and child health interventions under the following budget accounts: maternal child health, polio, family planning and reproductive health (FP/RH) and nutrition. FP/RH and nutrition operate through different accounts and are funded separately by the U.S. Congress.234 Similarly, FP/RH and MNCH are funded separately in the annual appropriations bills as part of the “Global Health and Child Survival” account. FP/RH and MNCH program areas are operated separately within USAID as well.234 Such separation often results in lack of cooperation and coordination between the two areas. For example, a USAID mission in Russia reported that the physical separation and lack of integration between FP and other MCH and social service centers, such as centers of social assistance to family and children, posed a serious challenge.235 Similarly, an Egyptian report noted that the failure to integrate vertical programs for family planning, reproductive health and maternal health was as a challenge to service delivery, including provision of and counseling on contraceptives.236

Global action Over the past two decades, there has been international progress on maternal and child health. In 1990, there was a World Summit for Children that highlighted children’s rights. In 1994, the fundamental role of women in the development process and the concept of reproductive rights were established at the International Conference on Population and Development (ICPD) in the Cairo Consensus,237 a plan that was forged by industrialized and developing nations. The Cairo Consensus made a commitment to meet the reproductive and family planning needs of all women, so that individuals and families would have choices about the spacing, 66 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

FP/RH and MNCH strategy program areas are operated separately within Congress.234 Such separation often results in lack of cooperation and coordination between the two areas.

timing and number of their children. It also developed a 20-year plan with goals centered on providing universal education, reducing infant, child and maternal mortality and ensuring universal access to reproductive health care (including family planning, assisted childbirth and prevention of sexually transmitted infections, including HIV/AIDS) by 2015.237 In 2000, during the Millennium Summit, world leaders adopted the United Nations Millennium Declaration and its eight Millennium Development Goals. The MDGs articulate 21 targets, as well as measurable indicators for each target, and span the issues of health, education, environmental stewardship, poverty and hunger. In 2002, the United Nations General Assembly held a special session on children, where world leaders and the international community participated with the goal of improving the situation of children and young people worldwide. This session was convened to review progress since the World Summit for Children in 1990 and to re-energize global commitment to children’s rights. Since the launch of this conference the international community’s attention toward MNCH has increased exponentially.238 In September 2008, the major four health agencies (the World Health Organization, The United Nations Population Fund, UNICEF and the World Bank) issued a joint statement that recognized the need to intensify support toward MDG 5—to improve maternal health—as this MDG was showing the least progress. The declaration included a pledge by the four organizations to enhance support to countries with the highest maternal mortality.239 In June 2010, the leaders of the eight richest nations met at the G8 summit in Muskoka, Canada, and endorsed and launched a Muskoka Initiative. This Initiative promotes a comprehensive and integrated approach to accelerate progress toward MDGs 4 and 5 that will significantly reduce the number of maternal, newborn and under-five child deaths in developing countries.240 To this end, the G8 promised to mobilize US$5 billion of additional funding for disbursement over the next five years, reiterating that G8 members already contribute over US$4.1 billion dollars annually in international development assistance for maternal, newborn and under-five child health. In addition to the G8’s commitment, the Muskoka Initiative has received promised support from governments—the United States, Canada, Netherlands, New Zealand, Norway, Republic of Korea, Spain and Switzerland— and organizations, subject to their respective budgetary processes. The Bill & Melinda Gates and UN Foundations have committed to additional funding of US$2.3 billion to be disbursed over the same period.240

In addition to the G8’s commitment, the Muskoka Initiative has received promised support from governments—the United States, Canada, Netherlands, New Zealand, Norway, Republic of Korea, Spain and Switzerland—and organizations, subject to their respective budgetary processes.

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In September 2010, the United Nations hosted a Millennium Development Goals summit with a special focus on MDG 1 (eradication of extreme poverty and hunger) and MDGs 4 and 5. The purpose of the summit was to raise and address UN concerns about the slow progress in improving maternal and child health.241 The summit resulted in the launch of a Global Strategy for Women and Children’s Health, estimated to prevent, between 2011 and 2015, the deaths of more than 15 million children under five, 33 million unwanted pregnancies, and the death of 570,000 women from complications related to pregnancy and childbirth, including unsafe abortion.228 The strategy brings together the UN agencies, private sector actors and other international organizations in an effort to strengthen national and local capacities to meet the comprehensive needs of women and children.

U.S. MNCH activities The U.S. Government has been engaged in efforts to improve child health since the 1960s. The first effort was a focus on child survival research, which also included pioneering research on oral rehydration therapy (ORT) conducted by the U.S. military, USAID and the National Institutes of Health (NIH).233 Over the decades, the maternal, newborn and child health agenda has been extended to cover additional diseases, countries and populations. Currently the U.S. Government is expanding maternal, newborn and child health activities by integrating them with family planning and reproductive health, and by linking HIV and malaria prevention and treatment to maternal and child health programming.

The main U.S. agencies in the MNCH arena include USAID, the Centers for Disease Control and Prevention (CDC), NIH and the Department of State. USAID is the lead government agency on MNCH efforts and receives most of the funding allocated for MNCH. State Department members, in particular Ambassador-At-Large for Global Women’s Issues, Melanne Verveer, are also active with regard to the MNCH agenda at the U.S. policy front. Alongside these agencies, the U.S. addresses many MNCH issues through cross-cutting initiatives, such as the President’s Emergency Plan for AIDS Relief (PEPFAR), the President’s Malaria Initiative (PMI), the Neglected Tropical Diseases (NTD) Initiative and the Feed the Future Initiative.

In 2008, the House of Representatives Committee on Foreign Affairs, Subcommittee on Africa and Global Health, held a hearing on child survival and mortality, and on how to improve U.S. efforts in global MNCH, resulting in the development of a five-year comprehensive MNCH strategy that has since been incorporated into GHI.242 Legislation aiming to improve MNCH efforts and activities include: The Newborn, Child, and Mother Survival Act of 2009 (H.R.1410); The Global Child Survival Act of 2009 (S.1966); The Global Sexual and Reproductive Health Act of 2010 (H.R.5121) and The Improvement in Global Maternal Health Outcomes While Maximizing Success Act, also referred to as the Global MOMS Act (H.R.5268). None of these bills has been signed into law and will require reintroduction in 2011.

Other bills that address MNCH, but focus on broader areas of global health, include The Global Health Act of 2010 (H.R.4933), whose purpose is to is to strengthen and improve health systems and the delivery of health services in developing countries; The International Violence Against Women Act of 2010 (S.2982) and The International Protecting Girls by Preventing Child Marriage Act of 2009 (H.R.2103) and its companion bill (S.987).

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In 2008, the House of Representatives Committee on Foreign Affairs, Subcommittee on Africa and Global Health, held a hearing on child survival and mortality and on how to improve U.S. efforts in global MNCH, resulting in the development of a five-year comprehensive MNCH strategy that has since been incorporated into GHI.242 USAID Since its early days in the 1960s, USAID has coordinated MNCH efforts in countries around the world. Today, USAID has programs on MNCH in 62 countries.243 Thirty of these countries have been designated as priority countries.244 Since the launch of the global program on immunization in 1974, USAID efforts have supported achievement of universal immunization coverage. When immunization coverage showed signs of stagnation in the late 1990s, the Boost Immunization Initiative aimed to strengthen immunization programs in countries with low or declining immunization rates.233 In 1985, USAID and the UNICEF launched a “child survival revolution” aimed at reducing the number of deaths among young children in developing countries. The U.S. Congress provided US$85 million for child survival activities, nearly doubling funding for this purpose from the previous fiscal years.

By 1986, USAID launched its first U.S. child survival strategy.233 USAID has also been very active in the promotion of exclusive breastfeeding as a cornerstone of child nutrition and health. Furthermore, USAID has also been a leader in combating severe, as well as mild, malnutrition and deficiencies in micronutrients, especially iron, iodine and vitamin A. USAID efforts to decrease neonatal mortality also led to the launch of a newborn survival strategy in 2001.233 In 1989, USAID expanded its agenda to include maternal health in its operations, responding to a long-neglected need for attention to maternal mortality and morbidity.245 By the early 1990s, USAID’s maternal/newborn health project mobilized a large educational campaign about complications of pregnancy and labor and about necessary emergency preparations. The campaign targeted community and religious leaders, women’s groups and men.

In 2002, USAID launched its Prevention of Postpartum Hemorrhage Initiative.233 This Initiative focuses on reducing obstetric hemorrhage, which is the world’s leading cause of maternal mortality, causing 24 percent of, or an estimated 127,000, maternal deaths annually. Postpartum hemorrhage (PPH) was the most common type of obstetric hemorrhage and accounted for the majority of the 14 million cases of obstetric hemorrhage that occur each year. Yet, despite many advances in maternal health and U.S. efforts in this arena, there are still 1,000 women dying each day from pregnancy related complications.246

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USAID is also active in promoting action to end violence against women, including legal counseling, fight against child marriages and gender equity. Ambassador Verveer is a strong opponent of genderbased violence and leads many US efforts in this arena.

USAID Maternal and Child Health Priority Countries, as of March 2008

The upsurge of attention and interest in maternal and child health issues since the 2002 special session on children held by the UN has also sparked Congressional interest in these issues. In 2008, USAID was directed to develop an integrated five-year strategy to address issues concerning MNCH.244, 242 The Obama Administration continued this trend with the launch of the Global Health Initiative, which has a particular focus on maternal health and takes a “women- and girl-centered approach� to global health.247 In 2008, USAID chose 30 priority countries to receive the majority of maternal and child health resources; these countries account for at least 50 percent of infant, child, and maternal deaths worldwide.244 Additional criteria used to select the countries include: governmental commitment to cooperate with the USAID mission; an existing USAID mission with adequate capacity; possibility of interaction with other U.S. programs, such as PEPFAR, PMI or Title II Food Aid; and an opportunity to leverage USAID resources with other funding possibilities, such as grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria or the GAVI Alliance.244 The priority countries do not fully overlap with the countries that UNICEF identifies as having the highest maternal and infant mortality rates, particularly in Africa. The overlapping countries are Kenya, Democratic Republic of Congo, Congo, Liberia, Nigeria, Rwanda and Malawi.

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Among U.S. policyU.S. family planning and reproductive health policy The cornerstone of U.S. policy on FP/RH has remained a commitment to international family planning programs, based on principles of volunteerism and informed choice, that give participants access to information on all major methods of birth control.248 The United States has supported international family planning assistance since the mid 1960s.249 In 1994, the U.S. was part of the ICPD Program of Action negotiations, which emphasized linkages between population and development, and established commitments for meeting reproductive health needs.

makers, FP/RH assistance has become a source of substantial controversy on two issues: the use of federal funds to perform or promote abortions abroad and how to deal with evidence of coercion in some foreign national

Among U.S. policy-makers, FP/RH assistance has family planning programs, become a source of substantial controversy on two especially in China. issues: the use of federal funds to perform or promote abortions abroad and how to deal with evidence of coercion in some foreign national family planning programs, especially in China. Currently, USAID provides a large array of services to aid women’s health including family planning, counseling and post-abortion services. Although USAID recognizes that unsafe abortion is a public health risk, USAID programs do not support or provide abortion services.250 Of the 56 countries receiving USAID assistance, 35 permit abortion without restriction as to reason or limit services to cases of fetal impairment, protection of a woman’s physical or mental health or socio-economic hardship.251

The Global Gag Rule The subject of abortion—including abortion education, legal abortion services or the provision of referrals for abortion services—continues to be a very sensitive issue in U.S. politics and funding decisions. The Foreign Assistance Act of 1961 (22 U.S.C. 2151b(f)(1)) prohibited non-governmental organizations (NGOs) that receive federal funds from using those funds “to pay for the performance of abortions as a method of family planning, or to motivate or coerce any person to practice abortions.”252 In August 1984, President Reagan directed USAID to expand this limitation and withhold USAID funds from NGOs that use non-USAID funds to engage in a wide range of activities, including providing advice, counseling, or information regarding abortion, or lobbying a foreign government to legalize or make abortion available. This mandate, known as ‘The Mexico City Policy’ or the Global Gag Rule, was in effect from 1985 until 1993, when it was rescinded by President Clinton. President George W. Bush reinstated the policy and subsequently extended it to voluntary population planning assistance provided by the Department of State.252 In 2009, President Obama revoked both the 2001 and 2003 Presidential Memoranda and waived the conditions for all USAID grants.252 United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 71

The Global Gag Rule restricted a basic right The Global Gag Rule restricted a basic right to speech and the right to make informed health decisions and to speech and the right harmed the health and lives of poor women by making it more difficult to obtain access to family planning to make informed health services. Poor women were disproportionately affected by this policy, as they often lack the resources to obtain decisions and harms a safe abortion and the restrictions often reduced other the health and lives of services.253 For example, in 2002, the Global Gag Rule resulted in the end of all shipments of USAID-donated poor women by making contraceptives to 16 countries and to leading family planning agencies in another 13 countries. In Kenya, it more difficult to obtain two leading health NGOs closed five clinics, cut up to one-third of their staff and reduced services in their access to family planning remaining clinics. One of the shuttered clinics had served a crowded slum neighborhood of Nairobi since services.

1984, providing sexually transmitted infection (STI) screening and treatment, family planning, pre- and post-natal obstetric services, and well-baby care. In Peru, USAID officials pressured an organization to withdraw from a campaign supporting emergency contraception (EC), even though EC helps prevent unwanted pregnancies and is not an abortifacient.254 A study of Ethiopia, Kenya, Peru and Uganda noted that the Global Gag Rule has had negative health effects.255 In all of the four countries, unsafe abortion is one of the major causes of death among women of reproductive age. In Ethiopia, unsafe abortion is the second leading cause of death for women of reproductive age. In Kenya and Uganda, unsafe abortions cause 40 and 33 percent of maternal mortality, respectively. The report indicated that the Global Gag Rule made discussion, debate or events related to unsafe abortion taboo, because NGOs The Global Gag Rule fear that the mention of abortion would result in their loss of funding from USAID. The policy and loss of has made discussion, funding also had an effect on family planning, HIV/ AIDS and emergency contraception services provided debate or events related by numerous NGOs.

to unsafe abortion taboo, because NGOs fear that the mention of abortion will result in their loss of

Although the Global Gag Rule was lifted by President Obama by an administrative order, it could be reinstated by a future president. In 2010, Senator Lautenberg offered an amendment to the current FY 2011 Senate Appropriations Bill to repeal the Global Gag Rule permanently, but this did not pass in Congress.

funding from USAID. 72 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

Kemp-Kasten Amendment Another obstacle to funding family planning and reproductive health services came with the introduction of The Kemp-Kasten Amendment in 1985. Kemp-Kasten was enacted through a United States Appropriations Act that included foreign operations. The provision prohibits foreign aid to any organization that the administration determines is involved in coercive abortion or involuntary sterilization. This statute had a particularly strong impact on the United Nations Population Fund, which is the major provider of family planning and reproductive services worldwide and is supported by major donors and countries globally.

Between 1985 and 2008, this amendment was used as the grounds for denying funding to UNFPA, claiming that it supported China’s coercive population control program. Throughout most of the Clinton Administration, Congress and the Administration fought over UNFPA funding, but it was only for FY 99 that all funding for UNFPA was blocked. In 2002, when President Bush was elected, the Kemp-Kasten Amendment was again invoked and UNFPA funding was denied. In 2008, President Bush took the amendment a step further, applying the amendment to Marie Stopes International (MSI), a UK-based NGO that provides family planning globally, because the organization worked with UNFPA in China. MSI does not receive U.S. funding, yet President Bush issued a directive through USAID prohibiting all African governments from distributing U.S.-donated contraceptives to the organization.

During the years when the U.S. did not contribute to UNFPA, other donors stepped up their commitments to meet the needs of the organization. However, UNFPA officials estimate that the US$34 million withheld by the U.S. would have prevented 2 million unwanted pregnancies, nearly 800,000 induced abortions, 4,700 maternal deaths, nearly 60,000 cases of maternal illness or disability, and 77,000 infant and child deaths.256 The Obama Administration waived the amendment and restored funding to UNFPA in 2009.257 However, as with the Global Gag Rule, a future president could invoke the provisions of Kemp-Kasten.

Integration of services Although USAID funded research in the 1980s and early 1990s to identify major causes of neonatal deaths, efforts to decrease neonatal mortality have had less success than programs geared toward slightly older children—most gains made in child survival were realized among infants and children between the ages of 1 month and 5 years.233 In part, neonatal mortality has declined more slowly than under-five mortality because interventions focused on addressing causes of death among the latter population (e.g., via vaccination, oral rehydration and bednet distribution campaigns) rather than neonatal causes of death.233 In 2001, USAID launched a new newborn survival strategy.233, 244, 257 The gap in neonatal interventions is being addressed through an emphasis on the use of skilled birth attendants at delivery, provision of antenatal care, essential care for all newborns, infection detection and treatment, and special care for low-birth weight newborns.233 In 2008, USAID launched the Maternal and Child Health Integrated Program (MCHIP).

MCHIP focuses on evidence-based interventions from pre-pregnancy to age five, and on linking United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 73

Although USAID funded communities, first-level facilities, and hospitals.

MCHIP also promotes and supports the integration of family planning, malaria, and HIV/AIDS activities within MNCH programs, as appropriate. USAID is trying to close the gap between evidence and its policies; it remains to be seen how the integration process will work in reality.

research in the 1980s and early 1990s to identify major causes of neonatal deaths, efforts

to decrease neonatal Integration of HIV/AIDS services with MNCH and FP/ RH services can prevent mother-to-child transmission mortality have had less of the virus, as well as provide needed counseling and medication to HIV-positive mothers and children.258 success than programs The newly established Global Health Initiative is trying to eliminate this separation through the Implementation geared toward slightly of the Global Health Initiative Consultation Document, older children. which lays the groundwork for RH/FP, MNCH and HIV integration within U.S. programming.259 A new PEPFAR five-year strategy also clearly outlines the integration of HIV/AIDS and the rest of U.S. health assistance, stating that “PEPFAR will be carefully and purposefully integrated with other health and development programs.”260 Yet to be defined is how the GHI targets and woman-centered approach will be integrated within the existing PEPFAR structure. A positive step forward is PEPFAR’s new indicators on genderbased violence and the role of family planning: “new indicators and budget codes to ensure GHI’s women- and girl-centered approach may help to ensure the tracking of these crucial integrated health services.”261

Conclusion Globally and in the U.S., there is political will to address maternal, newborn and child health issues and to reduce mortality. The U.S. has a comprehensive set of interventions to address these areas and new policies and strategies, including the Global Health Initiative. These policies incorporate women- and girl-centered approaches and the integration of care across the continuum from pre-pregnancy through the post-partum period and into childhood. Further, integrated care is encouraged across the vertical programming structure—incorporating MNCH with HIV/AIDS, malaria and other disease-specific interventions. Despite global and U.S. political and financial commitments, funding will not be adequate to fully address global MNCH needs.

A second gap is the relative neglect of neonatal services. Maternal and child health interventions have been addressed to a greater degree, but newborns have not seen the same level of commitment.

Although neonatal health is not a separate budget account and is not addressed through wholly separate interventions, new programming is drawing attention to these needs. Evaluation is necessary

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Despite global and U.S. to determine whether these policy and practice changes result in improvement on the ground.

political and financial commitments, funding

Less clear is U.S. commitment to reproductive health will not be adequate and family planning. Although there are promising signs that integrated programming will enable FP/ to fully address global RH programs to be delivered without encumbrance, the extent to which this will happen remains to be MNCH needs. seen. Funding shortfalls are also problematic for FP/ RH services—some of this may be mitigated by the integration of programs, though evidence is needed to demonstrate this outcome clearly.

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Key Findings and Recommendations

O

ver the past decade, U.S. global health policies have had tremendously positive outcomes —millions of people have

benefitted from HIV/AIDS, malaria, TB, maternal and child health and reproductive health services, and health care providers have received the training they need. The billions of dollars spent to implement global health policies and programs have been used to develop or reinforce the public health infrastructure of many countries and to draw attention to the need for improvements in water and sanitation, access to education, and empowerment of women and girls.

However, there are some weaknesses in U.S policies and their implementation.

Lack of agreement on goals and objectives Given that there are numerous stakeholders in global health, there are also disagreements about what course of action should be taken to address the diagnostic, prevention and treatment needs of people living in developing countries. The lack of a unified approach results in disparity between programs and disjointed service delivery.

The most at-risk populations living with HIV/AIDS experience stigma and discrimination because of their HIV status and their status in society, resulting in a reluctance to seek preventive, counseling and treatment services.

The relative lack of focus on TB is of particular concern, as multi- and extensively drug resistant strains of the bacteria are propagated in increasing numbers of countries.

PMI needs to offer more guidance on counterfeit and substandard drugs, antenatal care access for women seeking IPTp, ITN use and replacement, and use of IPTi for infants, in accordance with WHO guidelines.

The Global Health Initiative has incorporated women- and girl-centered approaches and the integration of care across the continuum from pre-pregnancy through the post-partum period and into childhood. Assessment is needed to determine whether the policy guidance is adequate to improve conditions for these populations.

Global Health Council position: unified strategy for action. Global health stakeholders should develop and implement the generally agreed-upon goals in a coordinated manner to achieve universal access to needed diagnostic, prevention and treatment services. For some issues, such as HIV/AIDS, this unified approach has been developed and requires implementation; for other issues, such as MNCH, strategies, goals and objectives need to be developed.

Lack of attention to public health One problem of global health policies and program is that public health principles and findings 76 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

are not always used as a foundation—rather, ideology and political expedience underlie some U.S. policies.

The retention of the anti-prostitution pledge in the PEPFAR legislation limits the ability to deliver services to this at-risk population. These men, women and in some cases, children need not only treatment services, but also access to prevention and screening tools.

PEPFAR has struggled with finding the right balance between the need for treatment and the need for prevention. Treatment efforts alone cannot stem or reverse the pandemic; robust prevention programming is essential. However, sustaining those already receiving ARVs and adding to their ranks the people whose CD4+ count indicates their need for medication are also essential.

The epidemiology of tuberculosis is known, drug regimes to treat TB have improved and there are diagnostic and preventive measures available at relatively low cost. However, TB and its co-infection with HIV remain a health threat in many parts of the world.

The relative neglect of neonatal services is of concern. Although neonatal health is not a separate budget account or addressed through wholly separate interventions, new programming needs to draw attention to the unique needs during the first month of life.

Global Health Council position: address disease burden. Global health policy and practice should reflect the disease burden in each country and address health systems strengthening, the underlying causes of illness and death, and the needs of poor or marginalized populations. This requires monitoring and evaluation of programs, surveillance to determine epidemiologic patterns and a comprehensive system that can address maternal and child health, reproductive health, HIV/AIDS and other infectious diseases, and chronic or non-communicable diseases.

Lack of national government authority and opportunity With PEPFAR II and GHI, there is a greater opportunity than in the past to enable national governments to take the lead in and responsibility for establishing health programming that reflects the country’s burden of disease. This requires several components, including establishment of national health plans, coordination of stakeholders and routine assessment to ensure that output and outcome targets are met.

Although PEPFAR, GHI, other U.S. policies and other international donors call for the development of national health plans and country-led operational plans, their effectiveness has not been well established. Some of these plans were only recently developed and may not be fully implemented; assessment is needed.

More concrete and useful data should be collected and shared, e.g., malaria program performance should be assessed on ITN use rather than procurement and distribution.

Monitoring and evaluation should look at how to improve existing programs, metrics and guidelines.

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Global Health Council position: country-led plans. National governments need to have the authority and opportunity, in partnership with other stakeholders (including NGOs, communities, and the private sector), to develop and implement national health plans. These plans need to reflect the unique burden of disease in that country, existing health systems structures and capacity of the country to respond to public health problems. These plans will also hold national governments accountable for implementing policies and programs that meet the health needs of the population.

Funding gaps The gap between global need and available resources is large and growing. Developing countries are forced to deal with this reality at a global level and at a national level.

The gap between those needing HIV/AIDS treatment and those receiving it will likely increase, as global funding levels off and more people are eligible for treatment under the new WHO guidelines that recommend starting treatment earlier in the course of the disease. The now chronic nature of the disease and the need for ongoing treatment highlight the concern over sustained funding.

Sustained HIV/AIDS funding at adequate levels is essential; the current scenario of flat funding has hampered treatment programs and prevention efforts in PEPFAR countries.

Increased funding for TB is needed to integrate cotrimoxazole and isoniazid preventative therapy with other health interventions (in particular with HIV/AIDS) and to scale up treatment efforts and the development of better tools.

Funding shortfalls are problematic for FP/RH services—some of this may be mitigated by the integration of programs, though evidence is needed to demonstrate this outcome clearly.

Integrated care is encouraged across the vertical programming structure—incorporating MNCH with HIV/AIDS, malaria and other disease-specific interventions. However, this requires a stable and sustainable infrastructure, which may be expensive. Although PEPFAR and other policies include some funding for health systems strengthening, there are relatively few funds specifically to integrate or to build health systems.

Global Health Council position: increased investments are needed. Despite the increase in U.S. government funding for global health, higher investments are needed to expand prevention and treatment services, particularly to at-risk populations. Funding for HIV/AIDS, malaria and TB needs to balance diagnostics, prevention and treatment. Investment in maternal, newborn, child and reproductive health must increase substantially to achieve MDG 4 and 5. Investment priorities should track countries most in need.

Lack of partnership and support disbursements Donor agencies and organizations have had mixed results when coordinating efforts on the development and harmonization of metrics, reporting requirements, funding mechanisms and 78 / United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011

funding priorities. In addition, transparency in decision making would be helpful in assessing how partners are working together and how disbursements compare to committed funds.

Transparency is needed in PEPFAR-funded programs to accurately record program impact —in terms of both outputs (e.g., number of people receiving ARVs) and outcomes (e.g., improved health for people living with HIV). This transparency has improved in past years, but greater information is needed to assess programs.

Monitoring and evaluation of PEPFAR-funded programs are needed to determine how well they are responding to country needs and whether interventions are meeting their targets of delivering care and improving health outcomes.

PMI programs should nonetheless continue to release monitoring and evaluation information to assess program impact.

PMI-funded programs need to provide information on how funding allocations are made.

U.S. commitment to reproductive health and family planning is promising, but it is unclear whether services will be delivered without encumbrance.

Global Health Council position: continue to build effective partnerships and shared commitments.

International stakeholders need to work together to establish effective partnerships and greater harmonization of programmatic and funding efforts. This collaboration promotes holistic and integrated strategies, systems and interventions. In addition, it is essential that donors meet and sustain their commitments, lest countries be unable to sustain health programs and systems.

Recommendations Promote integrated programs where possible—combine maternal, newborn, child and reproductive health services, as well as programs on HIV/AIDS, malaria programs and other infectious diseases. Integrate sexual and reproductive health services and counseling into HIV prevention, care and treatment interventions.

Implement a global plan of action to reach universal access for prevention, particularly for HIV/AIDS—for every person who receives ARV treatment, two become infected with HIV; gains in treatment cannot be sustained without greater attention to prevention. Scale up programs on male circumcision and concurrent partnering, especially in East and Southern Africa. Promote treatment as a means of prevention (i.e., ARVs lower viral load, which reduces the risk of transmission).

Emphasize health systems—ensure that resources are available for optimum delivery of care and training of health care workers, including skilled birth attendants and community health workers. Stable and convenient health systems promote primary health care, which can reduce costs by encouraging early diagnosis and preventive services.

Promote a woman-centered approach to HIV reduction and control—adopt the UNAIDS Action Framework for addressing women, girls, gender equality and HIV; work toward 80 United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 79

percent coverage of PMTCT programs. Use the Obama Administration’s GHI framing of a woman- and girl-centered approach to global health activities.

Establish standard metrics, methodologies and data collection efforts— ensure that monitoring and evaluation data, operations and implementation research measures, and health outcome information are systematically collected. Epidemiological assessments are needed to document each country’s burden of disease and target services (based on the evidence) to those most in need.

Increase investments for research—promote new vaccines, microbicides and medications, which are needed in all areas of global health. In particular, improved diagnostic and treatment options are needed for childhood diseases and conditions, e.g., child-focused HIV/AIDS treatment lags behind adult-oriented interventions, putting children at unnecessary risk. Program monitoring and evaluation, and operations and impact research are needed to improve interventions.

Deliver health services in an equitable manner—distribute care so that those most in need have access to services, particularly families with incomes in the lowest quintile and those in rural areas. Provide services to populations at high risk of HIV and STI infection (e.g., commercial sex workers, injecting drug users, men who have sex with men) to stem the spread of these diseases, and reduce the stigma associated with these vulnerable groups.

Promote national authority—enable countries to determine strategies for achieving MDGs 4, 5 and 6. Use the Three Ones Principle (one country plan, one coordinating mechanism and one monitoring and evaluation strategy) to frame the national health policies. These country-led national plans can focus on the country’s disease burden, use the approaches that are most cost-effective and efficient for the country, and expand community-based coverage to complement facility-based services.

Harmonize and increase funding from all sources—coordinate resources at the national level; streamline the evaluation and reporting processes to avoid duplication of effort and reduce administrative burden. Increase funding to meet the global need estimates, including those for the strengthening of health systems and integrated programming.

Hold governments to their international agreement commitments—both developing country governments, who need to increase domestic health expenditures, and donor governments who should meet their targets. In addition, stakeholders need to be accountable for results and ensure that countries and programs demonstrate that the resources spent can be linked to the results achieved.

Encourage inclusive partnerships and evidence-based programming—promote sustained commitment and collaboration in prioritizing and investing in global health diseases and conditions. In addition, effective partnerships (bringing together both public and private actors) can increase cost-effectiveness in service delivery by ensuring that all stakeholders are working toward a common goal.

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Conclusion In global health, it is important to focus on both the positive—what has already been accomplished —and to highlight remaining challenges, which indicate obstacles to achieving health and wellbeing for all. The U.S. Government and its partners have achieved remarkable successes in the fight to improve public health in developing countries and emerging markets around the world, with the potential to accomplish even more.

PEPFAR, PMI and related programs on maternal and child health, are now incorporated in the U.S. Global Health Initiative. The strengths of PEPFAR, PMI and U.S. policies on maternal and child health have been noted in this and other reports, as well as by OGAC and USAID, the principal agencies that administer these policies and programs. Yet, to identify the courses of action needed, it is important to identify policy and program gaps and point to opportunities for improvement.

Alignment of practices with policies and policies with available research promotes better programmatic outcomes, more efficient use of available resources and ultimately, better health for the world’s poorest people.

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Abbreviations ABC

Abstinence, be faithful, use condoms

MC

Male circumcision

ACT

Artemisinin-based combination therapy

MCHIP

Maternal and Child Health Integrated Program

AIDS

Acquired immune deficiency syndrome

MDG

Millennium Development Goal

ANC

Antenatal clinic

MDR TB

Multi-drug resistant tuberculosis

ARV

Antiretroviral drug

M&E

Monitoring & evaluation

BCG

Bacille Calmette-Guerin

MNCRH

Maternal, newborn, child and reproductive health

CDC

Centers for Disease Control and Prevention

MSM

Men who have sex with men

COPs

Country operational plans

NGO

Non-governmental organization

CSW

Commercial sex worker

NIH

National Institutes of Health

DDT

Dichlorodiphenyltrichloroethane

NTD

Neglected tropical disease

DOTS

Directly observed treatment, short course

OGAC

Office of Global AIDS Coordinator

DST

Diagnostic testing for drug susceptibility

ODA

Official Development Assistance

EC

Emergency contraception

ORT

Oral rehydration therapy

FGM

Female genital mutilation

PEPFAR

President’s Emergency Plan for AIDS Relief

FP/RH

Family planning / reproductive health

PLWHA

People living with HIV/AIDS

GHI

Global Health Initiative

PMI

President’s Malaria Initiative

GLC

Green Light Committee

PMNCH

Partnership for Maternal, Newborn & Child Health

HAART

Highly active antiretroviral therapy

PMTCT

Prevention of mother-to-child transmission

HBMF

Home-based management of fever

PPH

Postpartum hemorrhage

HHS

Department of Health and Human Services

RBM

Roll Back Malaria

HIV

Human immunodeficiency virus

R&D

Research & development

HLTF

High level task force

RDT

Rapid diagnostics testing

HVCT

HIV voluntary counseling and testing

SP

Sulfadoxine-pyrimethamine

ICPD

International Conference on Population and Development

SSA

Sub-Saharan Africa

IDU

Injection drug user

STI

Sexually transmitted infection

IPT

Isoniazid preventive therapy

TB

Tuberculosis

IPTp

Intermittent preventative treatment, pregnancy

UNAIDS

Joint United Nations Program on HIV/AIDS

IPTi

Intermittent preventative treatment for infants

UNFPA

United Nations Population Fund

IRS

Indoor residual spraying

UNICEF

United Nations Children’s Fund

ITN

Insecticide-treated bednet

USAID

U.S. Agency for International Development

LLIN

Long-lasting insecticide-treated nets

WHO

World Health Organization

MARPS

Most-at-risk-populations

XDR TB

Extensively drug resistant tuberculosis

United States Global Health Policies: Gaps and Opportunities for Improvement, January, 2011 / 91

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