Rapid hiv testing in the city of los angeles

RAPID HIV TESTING IN THE CITY OF LOS ANGELES ADDRESSING LEGISLATIVE, REGULATORY AND STRUCTURAL CHANGES NECESSARY TO INCREASE THE NUMBER OF RESIDENTS WHO ARE AWARE OF THEIR HIV STATUS

Karen Parker and Lindsey Zwicker UCLA School of Public Affairs, Department of Public Policy Applied Policy Project April 2009

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This report was prepared in partial fulfillment of the requirements for the Master in Public Policy degree in the Department of Public Policy at the University of California, Los Angeles. It was prepared at the direction of the Department of Public Policy and of Steven Simon, City of Los Angeles AIDS Coordinator, as a policy client. The views expressed herein are those of the authors and not necessarily those of the Department, the UCLA School of Public Affairs, UCLA as an institution, or the City of Los Angeles AIDS Coordinator.

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TABLE OF CONTENTS

Executive Summary

i

Introduction

1

Purpose of Analysis

5

Methodology

6

Background

7

Problem Identification

14

Criteria for Selecting Policy Solutions

23

Policy Options and Identified Solutions

24

Recommendations

30

Appendices Appendix A: Appendix B: Appendix C: Appendix D: Appendix E: Appendix F: Appendix G:

Glossary Political Flow Chart Los Angeles County Commission on HIV Health Services Membership Roster Testing Initiative Budget (Redacted) Cities, Communities, and Service Planning Areas Assembly Bill 221 Interviews

References

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EXECUTIVE SUMMARY Mayor Antonio Villaraigosa recently launched the City of Los Angeles HIV Testing Initiative - an endeavor to increase the availability and accessibility of HIV screening so that one million individuals in Los Angeles know their HIV status by 2011. This important public health intervention targets the estimated 7,500 Angelinos living with HIV who are unaware that they are infected and therefore precluded from obtaining life-prolonging medical treatment and social welfare services that could reduce their likelihood of transmitting the infection to other individuals.

The City of Los Angeles AIDS Coordinator’s Office has requested assistance and advice for implementing one of five strategic components to the City of Los Angeles HIV Testing Initiative: addressing legislative, regulatory, and structural changes needed to facilitate increased HIV testing.

This report initially sought to identify regulatory, legislative, and structural impediments to increasing the number of HIV screening tests performed in the City of Los Angeles. In the process of identifying such barriers we unearthed a disturbing discrepancy: an alarming number of people who test positive during HIV screening tests do not submit to confirmatory tests – a prerequisite for commencing medical treatments.

Los Angeles County data reveal that 32% of people who test positive for HIV at government-funded rapid testing sites do not submit a specimen for confirmatory testing. Out of the 68% who do submit a specimen, 50% do not return for the confirmatory results.

In response to this discovery, we recommend that our client redirect focus away from strategies to increase the absolute number of screening tests administered, and towards strategies to resolve the screening-toconfirmatory testing discrepancy. Merely increasing the provision of screening tests, without addressing the salient issue of the testing discrepancy could potentially undermine the very purpose of screening for HIV – to inform infected individuals of their HIV status so that they can receive proper medical care and curb risky behaviors that can lead to further transmission. We therefore contend that our client can achieve The City of Los Angeles HIV Testing Initiative’s ultimate goal – increase the number of people who know their HIV status – by pursuing the following recommendations: 



  

Reframe the issue: meet the stated goal of increasing the number of people who are aware of their HIV status by redirecting the focus away from strategies to increase the provision of screening tests, and towards the issue of people who fail to submit to confirmatory tests and do not get linked to life-saving, behavior-altering treatment and care.

Raise provider awareness: draw attention to the discrepancies in testing submission among community based organizations that provide rapid HIV testing in the City of Los Angeles. Encourage leaders to implement procedural adjustments to help decrease the number of HIV positive people who do not submit to confirmatory testing.

Decrease providers’ overreliance on oral-swab testing: fund phlebotomy training for staff members of community based organizations. Using funds from the City of Los Angeles HIV Testing Initiative, create a grant, subsidy or loan program to help offset the costs of limited phlebotomy certification.

Increase Director-level participation in the Los Angeles County HIV Prevention Planning Committee: work with the group that is federally mandated to conduct evidence-based research on prevention strategies in Los Angeles and influence county-wide change.

Support AB221: lobby Los Angeles-area legislators who sit on critical sub-committees and members of the California Nurses Association who wield political power and currently oppose legislation.

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INTRODUCTION HIV/AIDS: AN OVERVIEW The Acquired Immune Deficiency Syndrome (AIDS) and its source, the Human Immunodeficiency Virus (HIV), have been a part of the American lexicon since the early 1980s, when the virus first appeared in the gay communities of New York, San Francisco, and Los Angeles. In the nearly 30 years that have passed since initial outbreak, HIV/AIDS has become a prominent fixture in our nation’s agenda. Resources have been mobilized to combat both the virus and its attendant social stigma. Sophisticated surveillance systems and testing strategies work to track the disease and identify infected individuals who need care while advocacy groups continue to fight for resources in efforts to combat discrimination and expand treatment provision.

HIV is a retrovirus that affects the human immune system by infecting and then destroying CD4+ T lymphocytes (often called Helper T Cells) – white blood cells that regulate and control the human immune response. HIV can be transmitted through the exchange of blood, semen, vaginal fluids, or breast milk.1 Without treatment, the HIV virus continues to kill the CD4+ T lymphocytes until there are not enough cells to fight other infections.2 A healthy, HIV-negative person typically has between 800-1200 CD4+ T lymphocytes per cubic milliliter of blood. In infected individuals, the virus is reclassified as AIDS when the number of CD4+ lymphocytes falls below a certain level (usually around 200), rendering the individual exceedingly vulnerable to infection.3 In the absence of treatment, it takes an average of nine to ten years for HIV to destroy enough CD4+ lymphocytes for an individual to be classified as an AIDS patient. Once this occurs, infected individuals have an estimated 9 months of survival.4 People do not die of AIDS; they die of an opportunistic infection and the body’s inability to mount an effective immune response.

Although the HIV/AIDS pandemic runs rampant in many parts of the world, it is generally confined to certain segments of the population in the U.S. Following a peak of 130,000 new HIV infections per year in the mid-1980s, the Centers for Disease Control and Prevention (CDC) now estimates HIV incidence at approximately 40,000 new cases per year.5 A disproportionate number of those transmission incidents

The Centers for Disease Control and Prevention, “HIV/AIDS: Basic Information,” Department of Health and Human Services, http://www.cdc.gov/hiv/topics/basic/index.htmNo. transmission (accessed March 15, 2009).

2 Judie B. Alimonti, et al., “Mechanisms of CD4+ T lymphocyte Cell Death in Human Immunodeficiency Virus Infection and AIDS,” Journal of General Virology 84 (2003): 1649 – 50.

3 National Institute of Allergy and Infectious Diseases, “More on How HIV Causes AIDS, National Institutes of Health, http://www3.niaid.nih.gov/topics/HIVAIDS/Understanding/howhiv.htm (accessed March 10, 2009.

4 D. Morgan, et al., “HIV-1 infection in rural Africa: is there a difference in median time to AIDS and survival compared with that in industrialized countries?” AIDS 16(4) (2002): 597.

5 The CDC reports an estimated 509,681 people currently living with HIV/AIDS in the 33 states that participated in the federal surveillance program. The Centers for Disease Control and Prevention, “Basic Statistics,” Department of Health and Human Services, http://www.cdc.gov/HIV/topics/surveillance/basic.htm. (accessed March 11, 2009).

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represent infections among men who have sex with men,6 Black men and women, and Hispanic men and women.7 Exhibit 18 Transmission categories of adults and adolescents with HIV/AIDS diagnosed during 2006

Race/ethnicity of persons (including children) with HIV/AIDS diagnosed during 2006

There is no cure for the disease. However, since the advent of highly active antiretroviral therapy (HAART) in 1995, an HIV diagnosis is no longer an immediate death sentence.9 HAART dramatically improves survival rates among infected individuals and has effectively rendered HIV infection a chronic, manageable disease for those who are diagnosed early and maintain a strict drug regimen. Patients who begin a HAART regimen can extend their lives by an average of four to six years. The higher a CD4 cell count, the greater the benefits of HAART.10 Thus, the earlier infected individuals begin treatment, the greater their chances of long term survival.

The benefits of early detection and the immediate introduction of HAART drug regimen are not limited to patients. HAART dramatically reduces the viral load in an infected person and minimizes the risk of

Not all individuals who engage in sexual activity with same-sex partners identify as “gay” or “bisexual.” Thus, we refer to risk categories by behavior, rather than identity.

7 The Centers for Disease Control and Prevention, “HIV/AIDS in the United States,” Department of Health and Human Services, http://www.cdc.gov/hiv/resources/factsheets/us.htm. (accessed March 11, 2009).

8 Ibid.

9 Bernard M. Branson, et al., “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings,” CDC MMWR 55, no. 14 (2006), http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.

10 JT King Jr, et al., “Long-term HIV/AIDS Survival Estimation in the Highly Active antiretroviral Therapy Era,” Medical DecisionMaking 23(1), January-February, 2003: 9. The State of California Department of Public Health AIDS Drug Assistance Program (ADAP) provides HIV/AIDS drugs to people who cannot otherwise afford them.

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transmission to uninfected sexual partners.11 Early detection and the immediate introduction of a treatment regimen is therefore a public health matter.

HIV/AIDS: THE IMPORTANCE OF TESTING With an estimated one out of four HIV-positive Americans unaware of their infection, increased opportunities for testing are critical. Rapid HIV antibody tests provide new opportunities to improving access to testing in both clinical and non-clinical settings and increasing the number of people who learn their results.12 - Centers for Disease Control and Prevention A recent CDC study suggests that 24-27% of HIV positive individuals in the United States are unaware of their HIV status.13 Infected individuals who are unaware of their status not only fail to benefit from lifeprolonging medicinal treatments, but often continue to engage in risky behaviors through which the virus may to spread to others.14 Early testing is vital, both as a form of treatment and of prevention. Knowledge of one’s HIV status can dramatically affect risky behavior. A longitudinal study conducted from 1988 to 2003 explored the behavioral outcomes of HIV positive individuals before and after they became aware of their HIV status.

The results of the study revealed a 68% decrease in unprotected intercourse among HIV positive individuals who were aware of their status relative to HIV positive individuals who were unaware of their status.15 Study subjects expressed a desire to alter their behavior in order to avoid transmitting the infection to uninfected partners or in order to avoid further exposure to the infection.16 Until recently, HIV screening was primarily comprised drawing a human blood sample for laboratory analysis. Results could be determined in about one to two weeks. As a result of this waiting period, a high number of testers – including those who tested positive – failed to return to testing sites to receive their results. This phenomenon undermined the very benefit of HIV testing – to inform individuals of their HIV status so that they can avail of effective, life-prolonging treatment.

In 2003, the U.S. Food and Drug Administration (FDA) approved the first generation of “rapid HIV tests,” which could process human specimens (oral fluid or blood) and yield results within 20 to 40 minutes. The benefits of rapid testing for increasing HIV status awareness are twofold: 1) they can be administered in non-clinical settings, thereby increasing access to underserved and uninsured populations; and 2) the nearly complete removal of a waiting period means almost every individual who submits to a rapid HIV test learns

King, 10.

The Centers for Disease Control and Prevention, “Rapid HIV Testing,” Department of Health and Human Services, http://www.cdc.gov/Hiv/topics/testing/rapid/index.htm.

13 The Centers for Disease Control and Prevention, “Basic Statistics,” Department of Health and Human Services, http://www.cdc.gov/HIV/topics/surveillance/basic.htm.

14 Centers for Disease Control and Prevention, “HIV Testing,” Department of Health and Human Services, http://www.cdc.gov/hiv/topics/testing/index.htm.

15 Gary Marks, et al., “Meta-Analysis of High-Risk Sexual Behavior in Persons Aware and Unaware They are Infected With HIV in the United States: Implications for HIV Prevention Programs,” Journal of Acquired Immune Deficiency Syndrome 39 (2005): 1.

16 Marks, 5.

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his or her diagnosis.17 CDC aggressively promotes this exciting testing technology and its potential to expand the number of people who know their HIV status and to increase infected individuals’ linkage to care.

HIV/AIDS IN THE CITY OF LOS ANGELES The City of Los Angeles has the second highest number of infected residents in the United States.18 According to a 2005 study, an estimated 30,000 people are living with HIV/AIDS in the City of Los Angeles.19 Close to a quarter of all people living with the disease are not aware of their HIV status, suggesting that nearly 7,500 Angelinos are currently living with HIV/AIDS and unaware of their status.20 Social groups that bear a disproportionate burden of HIV/AIDS (Blacks, Latinos, and men who have sex with men) constitute a large portion of the City’s population. Out of approximately 3.84 million residents, Blacks make up 11.2% of the population and Hispanics, 46.5%.21 Although it is difficult to determine an accurate number of men who have sex with men, the Los Angeles metropolitan area is home to two large, vibrant, gay-identified communities: West Hollywood and Long Beach. The Los Angeles metropolitan area ranks second in the nation for its size of the openly gay, lesbian, bisexual and transgender population – 442,211 people.22 City of Los Angeles Testing Initiative On December 1, 2007, Mayor Antonio Villaraigosa launched the pilot phase of the City of Los Angeles HIV Testing Initiative, an effort to increase the availability and accessibility of HIV screening in order for one million individuals in Los Angeles to know their HIV status by 2011.

The City of Los Angeles HIV Testing Initiative is currently being implemented through the following five core strategies: 1. Increasing private-sector implementation of the Centers for Disease Control and Prevention (CDC) guidance on routine, clinical, HIV testing; 2. Increasing testing at special community-based events, sporting events, concerts, and institutions of higher learning; 3. Coordinating with local, state, and national faith based testing initiatives; 4. Expanding public school HIV/STD testing; and 5. Addressing the legislative, regulatory, and structural changes needed to facilitate increased HIV testing.

In Los Angeles County testing sites, 96.9% of people who submit to a rapid test receive their results, as compared to 71% of people who submit to a traditional test. See Exhibit 6.6.

18 AIDS Coordinator’s Office, “City HIV/AIDS Statistics,” City of Los Angeles AIDS Coordinator’s Office, http://www.lacityaids.org/hiv_stats.htm (accessed March 17, 2009).

19 AIDS Coordinator’s Office.

20 “Late Versus Early Testing of HIV: 16 Sites, United States, 2000-2003,” CDC MMWR 55, no. 14 (2006), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5225a2.htm. (accessed February 8, 2009).

21 U.S. Census Bureau, “State and County QuickFacts: Los Angeles (City), California,” http://quickfacts.census.gov/qfd/states/06/0644000.html, Accessed February 6, 2009.

22 Gary J. Gates, “Same-sex Couples and the Gay, Lesbian, Bisexual Population: New Estimates from the American Community Survey,” Williams Institute Study (October 2006), 1.

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PURPOSE OF ANALYSIS The objective of our analysis is to determine to what extent California-specific rules and regulations inhibit the ability of the City of Los Angeles to render one million residents aware of their status by 2011 and to recommend actions to mitigate their effects.

Rapid HIV testing is heavily regulated in the state of California. In the interests of public health and patient quality assurance, the California Department of Public Health (CDPH) imposes strict oversight and high standards of professionalism in the administration of rapid HIV tests. Our client, the City of Los Angeles AIDS Coordinator’s Office, maintains that the expansion of HIV testing in the City of Los Angeles is inhibited by unnecessary CDPH regulation and oversight.

Per our client’s request, we examined state-imposed certification requirements for non-clinical testing sites that provide rapid HIV testing. However, in the course of our examination of federal, state, and countylevel laws and regulations, we determined that increasing the provision of screening tests is not the most efficient way to facilitate HIV status awareness. Within the City of Los Angles, a high percentage of people who test positive during a rapid HIV screening test fail to submit to a confirmatory test – a mandatory step towards linkage to care for infected individuals. Therefore, this report explores solutions to this grave phenomenon and surmountable obstacles to implementing our proposed solutions. We explore impediments to expansion of screening tests primarily to convince our client of their intractable nature and the challenges that are likely to arise if continuing to pursue this direction.

Our goal is to recommend tenable and feasible policy options, given our client’s resources, jurisdiction, and external political and structural constraints. We analyze data and policy options with constant focus on the City of Los Angeles HIV Testing Initiative’s underlying objective: to increase the number of people who know their HIV status. Thus, we redirect our client’s a priori identified impediments to reaching this objective.

Our analysis of rapid HIV testing practices informs our conclusion that other impediments warrant serious consideration.

This report will not address issues of insurance coverage for testing, counseling models, or the routinization of screening in primary care settings. We will restrict our discussion to the roles of public entities and government agencies and their impact on rapid testing provision in publicly- funded testing sites. This report will not address demand for HIV tests or voluntary testing behaviors – critical components in increasing the number of people who test for and become aware of their HIV status. Strategies one through four of the City of Los Angeles HIV Testing Initiative address these issues. Therefore, they remain outside the scope of our assigned task.

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METHODOLOGY HIV/AIDS is an international public health priority. An elaborate network of regulation, research, funding, and political interests in protecting both the patient and society at large govern HIV/AIDS policy machinations. In order to determine the extent to which California-specific rules and regulations inhibit the expansion of the number of individuals who are aware of their HIV status, we must first ascertain the existence of the problem that our client had initially identified and second, uncover tenable policy solutions.

The recommendations in this report stem from three distinct examinations: 1) an evaluation of the supply and demand of HIV testing in the City of Los Angeles in order to determine whether the demand for rapid testing outstrips the City’s supply of rapid tests; 2) an investigation of the regulatory landscape in California in order to determine why the regulations were established, if they should be altered, and how and why they could be changed; and 3) an understanding of rules and regulations and their impact on service provision and utilization.

Epidemiologic Data The CDC, the State of California Department of Public Health, and County of Los Angeles Department of Public Health maintain extensive databases on HIV/AIDS epidemiologic surveillance. This report relies on the following information sources for local epidemiologic data: The County of Los Angeles Office of AIDS Programs and Policy HIV Counseling and Testing Annual Reports, 2007 Los Angeles County Department of Public Health Key Indicators of Health Survey, The County of Los Angeles HIV Prevention Plan 20092013, 2007 Los Angeles Coordinated Needs Assessment, and the January 2009 County of Los Angeles HIV Epidemiology Program Semi-Annual Surveillance Summary.

Interviews We conducted interviews with policy makers, program administrators, service providers, academics and physicians. Over a period of 10 weeks, we conducted 14 interviews with representatives from the following organizations: County of Los Angeles Office of AIDS Policy and Programs; California Department of Public Health, Division of Laboratory Field Services; The Center for HIV Identification, Prevention, and Treatment Services; David Geffen School of Medicine at UCLA; AIDS Healthcare Foundation; AIDS Project Los Angeles; Women Alive; Minority AIDS Project; San Francisco AIDS Foundation; San Francisco Department of Public Health HIV/AIDS Epidemiology Section.

Literature Review An extensive literature review was performed to gain baseline knowledge about the evolution of HIV/AIDS science, policy, and technological advancements in prevention, testing and treatment.

Limitations The administration of rapid HIV testing is extraordinarily political. Multiple stakeholders compete for the limited resources and revenue streams that finance testing. Due to the complex network of relationships and the agency for which this report was produced, our access to certain types of documentation, information, and opinions may have been limited. As a result, our conclusions and recommendations may be slanted towards the position of the agencies with which we had the most interaction.

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BACKGROUND HIV TESTING METHODS Two types of tests are necessary to diagnose someone with HIV (by testing for the presence of HIV antibodies in a human specimen): screening tests and confirmatory tests. Screening tests are highly sensitive (resulting in few false negatives), cheaper, easier to administer and generally well suited for testing large numbers of people. Screening tests are slightly less specific than confirmatory tests (resulting in a higher proportion of false positives); therefore, a screening test that returns a positive result is always followed with a confirmatory test before an individual is deemed HIV positive and eligible for treatment.

Traditional Testing Methods The traditional method of testing comprises drawing blood from a patient. Enzyme-linked immunosorbent assay (ELISA) – the traditional testing method used to detect the presence of HIV antibodies – has high sensitivity (100%) and specificity (99.9%).23 With traditional, blood-drawn ELISA tests, results are generally not available for one to two weeks after initial testing, thus requiring testers to return to the test administrator in order to learn their diagnosis.

If an ELISA test returns a negative result, other tests are not usually needed.24 If antibodies to HIV are present (a “positive” test outcome), a confirmatory test is used to rule out the possibility of false positive.

Testers who receive a positive ELISA test are told that they are “preliminarily positive” and must submit to a confirmatory, blood-drawn, test (either Western blot or immunofluoresence assay) in order to confirm their HIV-positive status . The confirmatory blood test results typically take about a week to process. An infected individual is not eligible for HAART treatment until he or she is confirmed positive by a Western blot test.

Rapid Testing Methods Rapid HIV tests come in two forms: oral swab and finger-prick. Human saliva or a drop of blood from a finger prick can be used to test for HIV antibodies. Results can be read visually and are ready in 20 to 40 minutes.25 Like the traditional ELISA tests defined above, rapid HIV tests are screening tests that require confirmation if antibodies are present. Thus, patients must submit to a confirmatory test before they are considered HIV positive and eligible for treatment.26

Federal Drug Administration, “Assay for the Detection of Antibodies to Human Immunodeficiency VirusType 1, Including Group O (HIV-1 + “O”) and/or Type 2 (HIV-2),” ADVIA Centaur Assay Manual. 2006. http://www.fda.gov/cber/pmalabel/P050030LB.pdf (accessed March 6, 2009).

24 “Human Immunodeficiency Virus (HIV) Test,” WebMD, (March 1, 2007), http://www.webmd.com/hiv-aids/humanimmunodeficiency-virus-hiv-test (accessed March 13, 2009).

25 Ibid.

26 Jeffrey L. Greenwald, et al., “A Rapid Review of Rapid HIV Antibody Tests,” Current Infectious Disease Reports 8 (2006): 125.

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Exhibit 2

Although the CDC and FDA have determined that accuracy levels for both rapid oral-swab and rapid finger-prick tests are acceptable for wide-spread provision, finger-prick rapid tests have slightly higher specificity.27 However, both federal agencies continue to advocate for rapid oral swab testing methods because the likelihood of false positive results is extremely low and the conventional testing algorithm requires that all positive tests are confirmed by the highly specific Western blot test. Furthermore, patients have a strong preference for submitting oral fluid over blood specimens, and at the macro-level, this type of test may increase the overall number of people who are willing to submit to a screening test. 28 Federal Requirements In 1988, Congress enacted the Clinical Laboratory Improvement Amendments (CLIA) to set “quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.”29 Under CLIA, any facility that examines human specimens for the purposes of diagnosing or treating disease must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain certification to perform diagnostic testing on human specimens. 30 The Centers for Disease Control and Prevention, “OraQuick Rapid HIV Test for Oral Fluid – Frequently Asked Questions,” Department of Health and Human Services, http://www.cdc.gov/Hiv/topics/testing/resources/qa/oralfluidqandafin.htmhttp://www.cdc.gov/Hiv/topics/testing/resources /qa/oralfluidqandafin.htm (accessed March 15, 2009).

28 Personal interview with Dr. Raphael Landovitz, January 26, 2009.

29 “Regulatory Oversight of Laboratory Testing Clinical Laboratory Improvement Amendments (CLIA)” (CDC Consultation on Rapid HIV Testing September 10-11, 2002), http://www.cdc.gov/hiv/topics/testing/resources/reports/pdf/CLIA_Background.pdf (accessed March 15, 2009): 3, citing DHHS, Office of the Inspector General. Enrollment and Certification Processes in the Clinical Laboratory Improvement Amendments Program. August 2001. Report OEI-05-00-00251. Available at: http://www.hhh.gov/oigoei.

27

The Centers for Disease Control and Prevention, “CLIA Certificate of Waiver Fact Sheet,” Department of Health and Human Services, http://www.cdc.gov/hiv/topics/testing/resources/factsheets/roltCLIA.htm (accessed March 15, 2009).

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The FDA categorizes all testing methods by their level of complexity: “high complexity, moderate complexity, provider-performed microscopy procedures, and waived.” 31 Each category of testing method has a distinct set of certification requirements that increase in stringency as complexity of testing method increases. This report assesses certification requirements for “waived” tests as both forms of rapid HIV tests, finger-prick and oral-swab, fall under this category.

Diagnostic tests are categorized as “waived” if they are (a) approved by FDA for home use or (b) determined to have an insignificant risk of erroneous result, including those that “are so simple and accurate as to render the likelihood of erroneous results negligible, or the Secretary has determined pose no reasonable risk of harm to the patient if performed incorrectly.”32 In 2003, the FDA granted waived status to rapid HIV tests due to their ease of use and high degrees of accuracy.33 Because they are classified as waived, rapid HIV tests can be administered in both clinical and non-clinical testing sites. Non-clinical testing sites must apply for a CLIA certificate of waiver or contract with an existing laboratory that is already certified in order to conduct rapid HIV tests.

In order to qualify for waived certification, testing facilities must certify to the rapid HIV test manufacturer that they agree to comply with a set of FDA requirements:    

Sale of HIV tests is restricted to clinical laboratories (any agency that performs rapid HIV tests is considered a clinical laboratory, and must have a CLIA certificate of waiver) A quality assurance plan (QA) for rapid HIV testing must be in place Staff have been trained to perform the test using manufacturer's instructions Clients will receive a “Subject Information” pamphlet before the test is given and receive appropriate information when results are provided34

Federal regulation provides that once the simple registration process is complete, a testing provider has the right to purchase CLIA-waived testing systems and perform rapid HIV tests. The fee for a Certificate of waiver is $150 and must be renewed every two years.35

Regulatory Oversight of Laboratory Testing, 3-4.

Regulatory Oversight of Laboratory Testing: 4; 42 CFR §493.17 (2001).

33 OraQuick Rapid HIV Test for Oral Fluid – Frequently Asked Questions.

34 CLIA Certificate of Waiver Fact Sheet.

35 Telephone interview with Donna McCallum, February 6,2009.

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THE BUREAUCRATIC STRUCTURE OF HIV/AIDS POLICY AND GOVERNMENT FUNDED SERVICE PROVISION [Refer to Political Flow Chart: Appendix B] United States Department of Health and Human Services At the federal level, the CDC, a division of the Federal Department of Health and Human Services, leads the national response to the HIV/AIDS epidemic. The CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention creates policy directives for surveillance and prevention strategies on the federal, state, and local levels.

The CDC works in partnership with the FDA, which is responsible for the “review and oversight function in areas related to drugs, biologics and medical devices for the prevention and treatment of HIV/AIDS, and AIDS-related conditions.”36 California Department of Public Health Pursuant to California Health and Safety Code §131019, the California Department of Public Health Office of AIDS (State OA) is responsible for facilitating HIV/AIDS programs, services, and activities at the state level.37 Composted of three branches (HIV/AIDS Epidemiology, HIV Care, and HIV Education and Prevention Services) and two sections (AIDS Drug Assistance Program and Administration), State OA has an annual operating budget of approximately $429 million.38 In addition to the State OA, the California Department of Public Health Laboratory Field Services Division (State LFS) regulates HIV/AIDS policy. State LFS maintains standards of quality and professionalism in laboratories through education, proficiency testing, licensing, examination, and inspection of labs and personnel.39 Most notably, State LFS oversees the regulation of HIV testing services by promulgating laboratory standards and personnel qualifications.

County of Los Angeles Public Health Department In California, county-level Health Jurisdictions (commonly referred to as county “health departments”) manage programs designed to promote public health.40 Since 1985, the Los Angeles Department of Public Health has maintained two departments dedicated to HIV/AIDS research, policy, and programming: The HIV Epidemiology Department (County EPI), which is responsible for the collection, analysis, and dissemination of HIV/AIDS-related data, and the Office of AIDS Programs and Policy (County OAPP),

U.S. Food and Drug Administration, “FDA’s Role in HIV/AIDS,” http://www.fda.gov/oashi/aids/fdarole.html (accessed March 17, 2009).

37 California Department of Public Health (CDPH), Office of AIDS, http://www.cdph.ca.gov/programs/aids/Pages/Default.aspx (accessed January 25, 2009).

38 CDPH, 3-YR Expenditures and Positions (Summary of Program Requirements) http://www.ebudget.ca.gov/pdf/GovernorsBudget/4000/4265.pdf (accessed February 20, 2009) 39 CDPH, Laboratory Field Services, http://www.cdph.ca.gov/programs/lfs/Pages/default.aspx (accessed January 20, 2009).

40 There are exceptions to this rule. Two cities within the County of Los Angeles, Long Beach and Pasadena, have created and operate independent departments of public health.

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which is accountable for the coordination of care and treatment services for people living with HIV and AIDS. 41 With an annual operating budget of nearly $84 million, and a staff of over 200, County OAPP coordinates all county-level HIV/AIDS planning and prevention activities, including oversight of two primary HIV/AIDS planning bodies within the County:42  

Los Angeles County Commission on HIV Health Services (Commission). Passed into ordinance by the County of Los Angeles Board of Supervisors in 1995, the Commission is charged with priority setting and allocation of HIV/AIDS-related care and treatment services in the County of Los Angeles.43 Los Angeles County HIV Prevention Planning Committee (PPC). Federally mandated by the CDC, the PPC was established in 2000 to oversee the direction of HIV prevention activities (including testing) within the County.44 The PPC is responsible, among other things, for assessment of the needs of highrisk populations, ongoing review of available resources, analysis of service gaps, and the prioritization of prevention needs.45 The PPC has recently published the County of Los Angeles HIV Prevention Plan 2009-2013, which serves as a guide to prevention and program services within the County.46

Both the Commission and the PPC are composed of representatives from government, community based organizations (CBOs), advocacy groups, and health care providers. Members are selected to represent demographic groups affected by the epidemic [Los Angeles County Commission on HIV Health Services Membership Roster: Appendix C]. 47 Funding for Rapid HIV Testing in the County of Los Angeles Publically-funded HIV testing sites primarily serve people who are most likely to submit to testing outside of traditional provider networks. In Los Angeles County, the County OAPP coordinates a county-wide network of strategically-placed, free, and low-cost HIV testing sites to reach the poor and uninsured: social groups with statistically lower testing rates than that of the general population.48

County of Los Angeles Office of AIDS Programs and Policies (Brochure), http://publichealth.lacounty.gov/aids/docs/OAPPBrochure.pdf (accessed February 16, 2009).

42 Ibid.

43 Ibid.

44 County of Los Angeles Department of Public Health, Office of AIDS Programs and Policy, Los Angeles County Prevention Plan 2009-2013, http://publichealth.lacounty.gov/aids/PPC/Prevention%20Plan%2009/TableofContents.pdf (accessed March 16, 2009): 1-5.

45 OAPP, Overview of the PPC, http://publichealth.lacounty.gov/aids/hivplancomm.htm (accessed February 28, 2009).

46 The 2009-2013 Plan was a participatory process, led by the PPC and OAPP. Participants Based on recommendations by the Counseling and Testing Work Group (a subcommittee of the PPC), the Los Angeles County Prevention Plan 2009-2013 has prioritized the following prevention efforts: outreach to high risk individuals; target testing models that produce higher positivity rates; and increase testing in medical care settings. The report does not identify or prioritize the creation of additional testing locations.

47 We made several requests to County OAPP to obtain an official roster for the PPC. We did not receive one. After reviewing meeting minutes for the last year we conclude that the City of Los Angeles AIDS Coordinator’s Office is not an active participant.

48 Oscar Grusky, et al., "ZIP code correlates of HIV-testing: A Multi-level Analysis,” AIDS and Behavior 10(5) (2006): 581.

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County OAPP and partner organizations operate testing centers in storefronts, mobile units, jails, drug treatment facilities, courthouses, and special testing events, and provide free and reduced fee testing in clinical settings (county and community clinics and family planning clinics).49 In between 2000-2006, the County OAPP provider network of free HIV tests in non-clinical settings discovered over 5300 new positive cases.50 The County OAPP administers State OA and CDC funding streams towards the majority of free and reduced- cost rapid testing sites in the City of Los Angeles.51 Health Jurisdictions (i.e. County OAPP as part of the County of Los Angeles Department of Public Health) and CBOs (via their Health Jurisdiction) contract with State OA to provide free and reduced fee HIV testing services.52 The state budgets a certain amount every year ($10.4 million in FY0753) to reimburse testing agencies for test kits and to fund a Fee-ForService reimbursement program. 54 The State OA purchases rapid test kits from test manufacturers at reduced rates and distributes the tests – at no cost – to Health Jurisdictions throughout the state. 55 56 County OAPP then distributes the free tests to the CBOs in the County of Los Angeles and is responsible for facilitating Fee-For-Service payments between State OA and the test providers.

Within the County of Los Angeles, County OAPP uses CDC funds to administer a Fee-For-Service-Plus and Cost Reimbursement programs, which provide additional funding to local CBOs. In FY08, County OAPP allocated $5.03 million from CDC funding to operate the Fee-For-Service-Plus reimbursement scheme.57 City of Los Angeles AIDS Coordinator’s Office Although the County of Los Angeles has jurisdiction over health-related issues, the City of Los Angeles officially pledged its support for HIV/AIDS programming in the mid 1980s with the creation of the AIDS Coordinator’s Office, administration of federally-funded housing programs for HIV-positive residents, development of an official City AIDS policy, workforce training programs for City employees, planning We made multiple requests for a comprehensive list of OAPP and non-OAPP funded testing sites in Los Angeles County. Our requests went unheeded.

50 Constance Chavers, “HIV Counseling and Testing 2005-2006 Data,” OAPP (PowerPoint Presentation, 2006), http://publichealth.lacounty.gov/aids/reports/PPC%20HCT%20Data%20Presentation%20Oct%204%2007.pdf (accessed February 19, 2009).

51 Agencies that provide free or reduced fee HIV tests, and are not designated as OA-funded sites are not entitled to free test kits nor Fee-For-Service or Fee-For-Service-Plus reimbursement from OAPP. Personal interview with Mario Perez, February 3, 2009.

52 To become eligible for OAPP funds, provider agencies first apply for a CLIA waiver, via LFS, and meet state and federal requirements. Personal with Sophia Rumanes, March 5, 2009.

53 Personal interview with Mario Perez, February 3, 2009.

54 Fee-for-service is a program to offset the staffing and administrative costs of HIV testing by reimbursing CBOs (via OAPP) for each test administered.

55 Interview with Kevin Farrell, February 23, 2009.

56 Both oral and finger stick tests retail for approximately $17.50/test kit. State OA pays approximately $9.50/test kit. Telephone interview with Kevin Farrell, January 23, 2009.

57 Interview with Mario Perez, February 3, 2009.

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forums for communities affected by the epidemic, and engagement of the City’s legal resources to tackle discrimination and social-welfare issues. 58 Located within the City of Los Angeles Department on Disability, the AIDS Coordinator’s Office (our client) maintains a full time staff of five and continues to be a leader in HIV/AIDS policy for the City of Los Angeles, relying on innovative and emerging research to better target programs to the populations in greatest need of prevention services.59 Current trends in HIV/AIDS research stress the importance of knowing one’s HIV status and the AIDS Coordinator’s Office is actively engaged in a city-wide campaign entitled “Get Tested” to encourage testing, treatment, and low risk behavior60 The City of Los Angeles HIV Testing Initiative, is one component of the “Get Tested” campaign.

Currently, the AIDS Coordinator’s Office operates on an annual budget of approximately $500,00061 from the City of Los Angeles General Fund and oversees $1.6 million in state and federal grants for policy and prevention programs.62,63 The City of Los Angeles HIV Testing Initiative has been allocated an operating budget of $797,415.00 (Initiative Budget: Appendix D].

Policy on the HIV/AIDS Epidemic, 6.

Within the City of Los Angeles, sexual contact, especially male-to-male, remains the primary path of exposure to HIV infection.

The majority of new cases are being discovered in communities of color and infections among women are rapidly increasing. In addition to targeting these populations, the ACO directs resources towards the underserved communities and groups for whom prevention services are considered deficient: immigrants, homeless individuals, non-injection drug users, transgendered, and sex workers 60 http://www.lacityaids.org/what_we_do.htm 61 Budget for the Fiscal Year 2008-2009, City of Los Angeles, http://www.lacity.org/ctr/abu1/AdoptedBudget2008-09.pdf (accessed February 23, 2009): 193.

62 Email communication with Ricky Rosales, February 7, 2009.

63 Organizations currently receiving funding from the City of Los Angeles Aids Coordinator include: AIDS Healthcare Foundation, AIDS Project Los Angeles, Asian Pacific AIDS Intervention Team, Asian American Drug Abuse Program, Inc., Bienestar Human Services, Inc., Children’s Hospital Los Angeles, Clean Needles Now, Common Ground, East Los Angeles Women's Center, Homeless Health Care Los Angeles, Los Angeles Gay & Lesbian Center, Reach LA, Tarzana Treatment Centers, Women Alive Coalition.

58 59

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PROBLEM IDENTIFICATION The City of Los Angeles Testing Initiative’s objective is to in increase the availability and accessibility of HIV screening in order for one million individuals in Los Angeles to become aware of their HIV status. The fifth component of the Testing Initiative, and the focus of this report, addresses legislative, regulatory and structural changes necessary to facilitate increased HIV testing.

After investigating the supply and demand of HIV testing in the City of Los Angeles and the impact of state- imposed regulations on the supply of rapid HIV testing, we conclude that facilitating an increase in HIV testing is not the most efficient way to reach the Initiative’s ultimate goal: to make one million individuals aware of their status. This conclusion is based on the following findings:  

 

A developed and well-funded testing infrastructure in Los Angeles already exists and at least one million residents have recently been tested for HIV.64 Our investigation revealed an issue that is more critical to HIV status awareness than initial screening expansion: a phenomenon we have termed “slippage.” An alarming number of people who test positive during a rapid HIV test do not submit to confirmatory testing. Los Angeles County data reveals that 32% of people who test positive for HIV at County OAPP funded sites (using rapid testing technology) do not submit a specimen for confirmatory testing. Out of the 68% who do submit a specimen, 50% do not return for the confirmatory results. The purpose of screening is to make people aware of their HIV status and the purpose of making people aware of their status is to immediately link infected individuals to care and to counsel behavior change.

Comparable metropolitan areas have implemented a new testing protocol into publicly-funded testing sites that has effectively decreased slippage and increased linkage to care.

California’s unique phlebotomy regulations inhibit rapid testing sites from training phlebotomists and prevent providers in the City of Los Angeles from capitalizing on this latest evolution in HIV testing.

SUPPLY AND DEMAND OF HIV TESTING IN THE CITY OF LOS ANGELES Los Angeles County is divided into eight Service Planning Areas (SPA), five of which lie, in whole or in part, in City of Los Angeles’ jurisdiction – SPAs 2, 4, 5, 6, and 8 (see Map of Cities, Communities, and Service Planning Areas: Appendix E).65 Where appropriate, data from all eight SPAs have been included in this report because people may travel outside of their area of residence to access HIV testing services. As a result, this section’s epidemiologic data will include results from SPAs outside of the City of Los Angeles (SPAs 1,3, and 7).

According to the County’s January 2009 HIV/AIDS surveillance report, there are 41,803 people living with HIV or AIDS in Los Angeles County.66 County EPI estimates that out of this total, 16,000 people living with HIV or AIDS are unaware of their status.67 According to a 2007 LA County Health survey, over

Getting people into testing has been identified as a major impediment to making people aware of their status. Because the first four goals of the Testing Initiative address this issue we will restrict our analysis to the supply side of HIV testing.

65 The City of Los Angeles does not maintain its own epidemiologic data; the information presented in this section is extrapolated from data collected and analyzed by the Los Angeles County Department of Public Health.

66 County of Los Angeles HIV Epidemiology Program Semi-Annual Surveillance Summary January 2009, 1.

672009-2013 Prevention Plan.

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2,216,000 county residents (30.5% percent of the population) had been tested for HIV in the two years preceding the study (Exhibit 3).68 Exhibit 3 Percent of Adults (18+ years old) tested for HIV in the past two years [LA County Health Survey, 200769] SPA Percent 95% CI Estimated Number 1 28.4% 22.8 – 34.1 66,000 2 26.8% 23.7 – 29.9 410,000 3 23.4% 20.4 – 26.4 315, 000 4 36.9% 32.8 – 41.0 337, 000 5 22.3% 17.5 – 27.2 112,000 6 46.3% 41.1 – 51.5 308,000 7 32.1% 27.7 – 36.4 304,000 8 32.2% 28.1 – 36.2 365,000 Total 30.5% 29.0 – 32.0 2, 216, 000 Nearly 52% of HIV tests that took place in the two years prior to the 2007 Los Angeles County Health survey were administered during routine medical checkups (Exhibit 4). County or community clinic and family planning clinics constitute the second and third most frequently cited providers of HIV tests, respectively (Exhibit 4).70 Exhibit 4 Location of most recent HIV test during the past 2 years among adults (18+years) [Los Angeles County Health Survey 2007] Location for HIV Test Percent 95% CI Estimated Number Family Planning Clinic 16% 13.8-18.1 350,000 Private MD office, lab, or HMO 51.9% 48.9-54.9 1,137,000 County or community clinic 21.8% 19.3-24.3 478,000 Van/mobile testing unit 2.8% 1.7-3.8 61,000 Home 1.45 .8-2.1 31,000 Other 5.8% 4.4-7.3 128,000

This statement represents the most up-to-date figures and is used by the County of Los Angeles for planning purposes. The results of the 2007 study have not yet been published and were obtained by request to the Department of Health Assessment and Epidemiology.

69 Estimates are based on self-reported data by a random sample of 7,200 Los Angeles County adults, representative of the adult population in Los Angeles County. The 95% confidence intervals (CI) represent the variability in the estimate due to sampling; the actual prevalence in the population, 95 out of 100 times sampled, would fall within the range provided.

70 Estimates are based on self-reported data by a random sample of 7,200 Los Angeles County adults, representative of the adult population in Los Angeles County. The 95% confidence intervals (CI) represent the variability in the estimate due to sampling; the actual prevalence in the population, 95 out of 100 times sampled, would fall within the range provided.

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Eighty percent of adults (18+ years) in Los Angeles County have a regular source of health care and have had a routine check-up within the last two years.71 This information indicates that nearly 20% of Los Angeles County residents do not have regular access to the most commonly identified HIV testing location – private doctor’s office, lab, or HMO. County OAPP-funded testing sites throughout the County that offer free and low cost HIV testing target and serve communities of individuals who are unlikely to have a regular access to primary medical care.

Since 2006, County OAPP and AIDS Project Los Angeles have maintained a comprehensive service directory to assist consumers in accessing 135 testing sites (Exhibit 5).72 In 2007, 33, 367 County OAPP-funded tests were performed (See Exhibit 5 for a breakdown of County OAPP-funded tests by SPA). The number of testing sites and providers in each SPA correlate with the number of people living with HIV/AIDS (PLWHA) within each area (Exhibit 5). Recent LA County Department of Health surveys estimate that 85% of adults know that free HIV testing is available.73 Exhibit 5 Provision of free or subsidized HIV testing in Los Angeles County in 2007 SPA No. Sites with Mobile No. No. of OAPP HIV+ free/subsidized testing providers funded tests diagnoses79 74 75 76 77 78 HIV testing units total performed , 1 8 No 7 486 ≤5 2 22 Yes 13 3,752 28 3 15 No 12 3,216 23 4 40 Yes 24 17,456 285 5 10 Yes 10 879 ≤5 6 11 Yes 10 4,209 45 7 11 Yes 8 1,911 38 8 18 Yes 17 1,458 26 Total 135 N/A overlap 33,367 ≤455

PLWA80 233 2,786 1,471 7,893 1,139 2,167 1,379 4,006 21,858

According to Mario Perez, Director of County OAPP, this system of free and low-cost HIV testing services is not currently operating at capacity – the supply of testing services actually exceeds the demand. Kevin Farrell, Executive Director of the Center for HIV Identification, Prevention and Treatment Services (CHIPTS) and former Chief of HIV Education and Prevention in the State OA, has corroborated this Note: there is not a wide variation among SPAs. Personal interview with Kyle Baker, February 3, 2009.

73 County of Los Angeles, Public Health, “Knowledge and Perceptions of HIV/AIDS in Los Angeles County,” LA Health (December 2007), http://www.lapublichealth.org/ha/reports/HIV%20Brief%20-%20Final%20Draft.pdf (accessed January 20, 2009).

74 AIDS Project Los Angeles, HIVLA.org, http://www.hivla.org/search.cfm (accessed April 22, 2009) 75 Ibid.

76 Ibid.

77 Does not include tests provided in doctors offices or non-OAPP funded sites.

78 2007 Data (extrapolated from 2007 HIV Counseling and Testing Annual Report).

79 2007 Data (extrapolated from 2007 HIV Counseling and Testing Annual Report).

80 2009-2013 Prevention Plan, page 34 Table 208.

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notion. Assessing ways to increase testing supplies when community demands for HIV testing services fall short of the existing supply is an inefficient use of public resources. We therefore redirect our focus to a more targeted mode of increasing individuals’ knowledge of their HIV status on the supply side of HIV testing.

DISPARITY IN THE NUMBER OF PEOPLE WHO TEST POSITIVE IN SCREENING TESTS BUT DO NOT SUBMIT TO CONFIRMATORY TESTS As reported earlier, in the course of our analysis, we found that a high level of slippage occurs between individuals who test preliminarily positive during rapid tests and those who submit to a confirmatory test.

Because individuals must have a confirmatory positive test in order to get linked to treatment, the size of slippage undermines the very purpose of screening – to get individuals to learn their HIV status so they can get appropriate medical treatment. Although increasing the supply of rapid testing – and resolving regulatory, structural, and legislative impediments – constitutes a logical method for increasing the absolute numbers of individuals who know their HIV status, the disparity in individuals who test positive and individuals who follow-up on a positive test warrants serious attention.

As the Summary Data from Exhibit 6 suggest, approximately 32% of County OAPP-funded testers who are preliminarily positive do not submit to a confirmatory test. Further, only 50% of individuals who test positive during a confirmatory test receive their results. The disparity between people who test preliminarily positive and people who submit to confirmatory tests warrants a caveat: the size of slippage reflected in the County’s testing data might be falsely inflated because some individuals who test preliminarily positive at a County OAPP-funded site might seek confirmatory tests from their private primary care physicians.

Therefore, a number of testers who submit to County OAPP-funded rapid tests would be included in County data on rapid testers but would be missing from County data on County OAPP-funded confirmatory tests, falsely decreasing the number of positive testers who fail to submit for a confirmatory test. However, the reported number of preliminarily positive testers who do not submit to confirmatory tests is startling, nonetheless.

Exhibit 6

Summary Testing Data from Los Angeles County OAPP-funded Sites, 200781 Characteristic Number of HIV Tests Number of New Positive Tests Disclosure of All Test Results Disclosure of New (Initial) Positive Results Submitted specimen for laboratory based confirmatory testing Received confirmed positive result (following submission)

All Tests

Rapid HIV Tests N % 22,298 66.8% 353 78.3% 20,929 93.9% 342 96.9%

Conventional HIV Tests N % 11,069 33.2% 98 21.7% 8,934 80.7% 70 71.4%

N 33,367 451 29,863 412

% 100% 1.35% 89.5%

-

-

240

68%

-

-

-

120

50%82

-

-

http://publichealth.lacounty.gov/aids/reports/HCTCY2007ReportFinal.pdf, p. 5 NOTE: The County reports this as 50% but in actuality only 34% of new positives initially diagnosed with a rapid HIV test received confirmed positive results (120/353).

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Given these results at this stage in our problem identification, the issue of “slippage” emerges as our investigation’s most appropriate focus. In light of the facts that 1) our data do not support a deficiency in supply, relative to the demand for testing; 2) our data indicate that at least one million people in the City of Los Angeles have recently been screened for HIV; and 3) a large percentage of people who have been screened for HIV do not submit to confirmatory testing, we determine that increasing the provision of HIV screening tests is not the best way for the Testing Initiative to meet its ultimate goal of making one million people aware of their HIV status. Therefore, decreasing the number of people who fail to follow up on a screening test constitute the crux of our report’s purpose.

A Promising Solution to Slippage The CDC and the U.S. Military HIV Research Program recently conducted studies in which rapid fingerprick tests were used to confirm positive rapid oral-fluid tests. 83 Rather than referring preliminarily positive patients to a laboratory for a confirmatory Western blot test (after which patients wait about one week for their confirmed results), providers followed up positive rapid oral-swab tests with rapid finger-prick tests.

The CDC and US Military studies revealed that this new “rapid testing algorithm” (RTA) has an accuracy rate comparable to that of the conventional testing algorithm (positive oral swab test, followed up with a Western blot test).84 Unlike the conventional testing algorithm, testers can receive confirmation of their status and get linked to care within about an hour of arriving at a testing center. According to the CDC study, twenty-eight false-positive tests were resolved with RTA intervention sites within one hour and 100 % of the positive RTA testers were immediately linked to care without waiting the requisite week to obtain confirmatory Western blot test results.

The RTA’s reliability and relatively fast turnaround time constitute a viable solution to slippage. The San Francisco Department of Health (SFDH) has implemented RTA into practice in all SFDH-funded testing sites by dedicating funding for training limited phlebotomists to staff each site.85 These policies have reduced the number of positive testers who fail to submit to a Western blot test and who subsequently fail to get linked to medical care in San Francisco County.86 Integration of RTA into practice in Los Angeles County is an obvious solution to the high level of slippage.

However, strict California regulations on finger-prick testing and many Los Angeles-area testing agencies’ inability to comply with these regulations and conduct finger-prick tests effectively preclude Los Angeles rapid testing sites from reducing slippage through integration of RTA practices. Unlike SFDH, LA County OAPP lacks the money necessary to fund limited phlebotomy training for staff members at all County J. Rurangirwa, et. al., “Impact of a Rapid HIV Testing Algorithm on Receipt of HIV Testing and Referral to Medical Care” (PowerPoint presentation presented at American Public Health Association, 136th Annual Meeting and Exposition October 28, 2008).

84 The U.S. Military HIV Research Program conducted a recent study in military testing sites. The study examined the reliability of RTA in designated military testing sites against the traditional algorithm in designated control sites. All Rapid Test combinations yielded 100% sensitivity and specificity compared with EIA/Western blot. Thirteen samples with discordant results were correctly resolved by the algorithm design (best of three). The accuracy of combinations of HIV Rapid Tests used in a parallel algorithm is comparable to that of EIA/Western blot. The study concluded that these Rapid devices could be used in civil military emergencies or in prevention and counseling clinics to provide rapid and accurate HIV diagnosis. E. Calero1, et al., “Rapid HIV-1 Diagnostic Algorithms for Use in HIV Infection Screening,” The US Military HIV Research Program, Henry M. Jackson Foundation for the Advancement of Military Medicine 3091. September, 2006.

85 Telephone interview with Terry Dowling, March 6, 2009.

86 Ibid.

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OAPP-funded testing sites.87 Thus, state policies that mandate strict training requirements for administering finger prick tests affect publicly funded testing practices differently in Los Angeles and San Francisco Counties.

Exhibit 7

STATE OF CALIFORNIA REGULATION OF RAPID HIV TESTING The State of California, via State Office of AIDS (State OA) and Lab Field Services (LFS), imposes regulations and requirements for rapid HIV test provision at the agency and individual provider level, in addition to CDC- and FDA-imposed regulations.88 Agency level: All agencies within the state must first register with LFS and operate under the administration of a Licensed Clinical Laboratory Director, in addition to fulfilling federally-mandated quality assurance and registration requirements. Clinical Laboratory Directors are responsible for the operation and administration of the laboratory, hiring personnel, and reporting test results. The Director must be accessible, but not necessarily on site during testing. Clinical Laboratory Director must be in possession of an advanced degree (MS, DO, or MD), a certain number of years of experience, and must pass a LFSadministered examination. 89

Personal interview with Sophia Rumanes, March 5, 2009.

Ibid.

89 CDPH Laboratory Field Services, Information/Instructions for Clinical Laboratory Director Licensure. http://www.cdph.ca.gov/programs/lfs/Pages/LaboratoryDirectors.aspx (accessed April 22, 2009).

87 88

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Provider level: In order to receive State OA/County OAPP funds (free rapid test kits, Fee-For-Service, and FeeFor-Service, and Cost-Reimbursement), all rapid testing administrators of waived HIV tests must: 1) Be counselors in good standing, or other health care personnel qualified to conduct CLIA-waived testing under BPC 1206.5; and 2) Have successfully completed State OA-provided training in conducting the rapid HIV test. This training includes instruction on operation of the test kit, universal precautions, selected quality assurance procedures, and a proficiency exam for test kit operations.90 At the onset of this project, our client indentified these state-imposed CLIA waiver requirements as barriers to rapid testing expansion; however, many agencies that provide CLIA waived tests can sub-contract with certified laboratories that have a Clinical Laboratory Director who is willing to assume oversight responsibility for the testing site and its test providers. 91 Assembly Bill 1442: Clinical Laboratories In 2007, the AIDS Coordinator’s Office actively supported State Assembly bill AB 1442, which took aim at the state’s CLIA waiver requirements. Sponsored by Assembly member Mike Feuer, AB 1442 sought to alter state-imposed requirements for obtaining CLIA waived status so that rapid testing sites must simply comply with CDC’s lenient guidelines and bypass LFS oversight and registration requirements. The bill passed through both houses of state legislature before Governor Schwarzenegger ultimately vetoed it.92 Although the Governor’s office expressed agreement with the bill’s objective, it preferred to accomplish it through regulation, rather than legislation.93 The State Office of AIDS (State OA) has not released an official position on this bill; however, it was not listed as an official supporter or detractor. Advocates for this bill sought to reduce an 18-month backlog in LFS certification when the rapid testing was first introduced. Over the past year, this backlog has subsided, thus rendering registration with LFS a minor inconvenience with a 30-day waiting period, rather than complete impediment to rapid test provision94.

Limited Phlebotomy Certification Although the state recognizes both rapid oral-swab and rapid finger-prick tests as waived under CLIA, it imposes additional requirements for finger-prick test providers, pursuant to Administrative Code title 17, section 1034. In order to perform rapid finger prick tests, providers must possess limited phlebotomy certification. Aspiring limited phlebotomists must complete a LFS-approved course in limited phlebotomy training. These courses range in price from $265 to $1000, not including expenses for books and supplies.95 CDPH, Office of AIDS, CLIA-Waived Rapid HIV Testing, http://www.stdhivtraining.org/resource.php?id=191 (accessed March 9, 2009).

91 When rapid testing was first introduced, the County of Los Angeles offered the opportunity for agencies to sub-contract under the OAPP Clinical Laboratory Director in order to take advantages of the rapid testing technology. The County has since weaned agencies off of their CLIA waiver and facilitates inter-agency subcontracting.

92 To this date, the regulation has not been forthcoming and we were unable to determine where it stood in the process.

93 San Francisco, AIDS Foundation, Update on Key HIV/AIDS Bills, http://www.sfaf.org/default.aspx?pid=1376&region=1&language=1 (accessed March 14, 2009).

94 Telephone interview with Courtney Mulhearn-Pearson, February 26, 2009; Personal interview with Sophia Rumanes, March 5, 2009.

95 State of California-Health and Human Services Agency, California Department of Public Health, Laboratory Field Services Licensing and Certification, https://secure.cps.ca.gov/cltreg/pt_faq.asp (accessed March 1, 2009).

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Upon completion of the training course, technicians must sit for a qualifying exam and then pay $54 to apply for LFS certification. Certification must be renewed every two years by paying another application fee and completing six hours of continuing education with a LFS-approved training program.96 Throughout our interviews, we found a general consensus that the aforementioned phlebotomy certification requirements are prohibitive to testing providers, particularly to small, poorly-funded organizations that target communities with the highest rates of prevalence and risk. Many organizations only provide oralswab testing in order to avoid the high cost of hiring, training and staffing certified limited phlebotomists to perform finger prick tests. In 2008, 20,026 oral fluid tests and 3,170 finger prick tests were administered at County OAPP testing sites (Exhibit 8).97 During that same year, over 155 County OAPP testing sites administered only oral fluid tests.98 Exhibit 8 Rapid Testing Specimen Type (Oral vs. Finger-prick) by Testing Site SPA, Calendar Year 200899 Service Planning Area Oral Swab Finger-prick SPA 1 77 0 SPA 2 1178 491 SPA 3 2938 11 SPA 4 12329 1629 SPA 5 91 0 SPA 6 680 804 SPA 7 2179 163 SPA 8 554 72 Total 20026 3170 The considerable number County OAPP-funded testing sites that only provide rapid oral swab tests reflects many sites’ inability to maintain a phlebotomist on staff to administer the rapid finger prick tests. Thus, a considerable number of County OAPP-funded sites are ill-equipped to practice RTA – a viable solution to slippage.

Assembly Bill 221: An act to amend Section 120917 of the Health and Safety Code, relating to public health On February 4, 2009, Assembly Member Portantino introduced AB 221 to California State Legislature (Text of legislation: Appendix F). The bill proposes to amend section 120917 of the Health and Safety Code so that an HIV counselor, who is trained in compliance with the Department of Public Health’s training requirements and who works under a licensed physician, would be exempt from the phlebotomist

California Department of Public Health, Laboratory Field Services, “Phlebotomy Certification: Frequently Asked Questions,” http://www.cdph.ca.gov/programs/lfs/Documents/Phlebotomy%20FAQ071106.pdf (accessed March 1, 2009).

97 HIV Counseling and Testing Data, HIV Resources Information Systems (HIRS), Jan through Dec 2008.

98 Ibid. As noted earlier in the report, County OAPP provides funding for 135 testing sites. (Exhibit 5). The number 155 includes temporary testing sites (community health fairs, special events, etc.) as well as permanent testing locations.

99 County of Los Angeles HIV Counseling and Testing Data, HIV Resource Information System, Jan through Dec 2008.

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certification requirements for rapid finger-prick testing.100 Proponents of the legislation assert that as technology changes and HIV testing methods evolve, regulation must keep pace in the interests of public health. 101 Current regulations concerning phlebotomy regulations inhibit the widespread adaptation of the RTA. The time and monetary costs of achieving and maintaining phlebotomy certification cause test administrators to over-rely on oral fluid testing.102 The California Nurses Association – AB 221’s most politically influential opponent – has expressed concern that loosening phlebotomy regulations will diminish professional standards.103 On March 31, 2009, the Subcommittee on Business and Professions passed this bill and re-referred it to the Sub-committee on Health.

On April 21, 2009, the bill was re-introduced to the Sub-committee on Health, where it is currently languishing. If it passes both sub-committees, the California state legislature will vote on AB 221 in September 2009.

Personnel operating the test kit must also be qualified to conduct necessary sample collection, either by virtue of their scope of work, or via phlebotomy certification. TO conduct finger sticks, personnel are required to be certified as Limited Phlebotomy Technicians (LPT); Venipuncture requires certification as a Certified Phlebotomy Technician 1.

101 To date, San Francisco AIDS Foundation and AIDS Healthcare Foundation 102 Courtney Mulhearn-Pearson, Podcast, San Francisco AIDS Foundation, http://ga4.org/sfaf/noticedescription.tcl?newsletter_id=30964987 (accessed February 22, 2009).

103 Telephone Interview with Israel Nevis, March 6, 2009.

100

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CRITERIA FOR SELECTING POLICY SOLUTIONS Given the political hotbed that is the HIV testing environment, the limited funding available for screening within the County, and California’s uniquely stringent regulations and health and professional codes that govern provider activity, it is important to consider three major factors when evaluating policy solutions for increasing the number of people who are aware of their HIV status: 1) the political feasibility of a solution; 2) structural feasibility; and 3) technical feasibility.

Political feasibility: Navigation of complex political relationships The expansion of rapid HIV testing is extraordinarily political – resources and revenue streams that finance testing are limited and there are multiple stakeholders, oftentimes with competing interests. Governmental and community-based agencies at the city, county, and state levels have developed an intricate system of allegiances in the fight for funding and the pursuit of agendas.

In nearly all of our interviews with policy-makers and agency leaders, Lab Field Services (LFS) was identified as a politically influential entity within California Department of Health (CDPH). LFS maintains a strong interest in protecting patients’ quality of care and ensuring provider compliance with mandated standards of testing and counseling.104 Therefore, any potential solution must conciliate state-level agencies – such as LFS – that possess the capacity to influence legislation and regulation in order to be politically feasible.

For purposes of this report, we will measure the political feasibility of each proposed policy option against our client’s ability to collaborate with other members of the HIV policy-making community, forge and maintain alliances with key political players and policy makers, and influence key decision maker’s amenability towards facilitating a given policy change.

Structural feasibility: Navigation of External Constraints The AIDS Coordinator’s Office’s limited jurisdiction, public funding streams, budgets, and legislative constraints at the County, State, and Federal levels restrict changes to rapid HIV testing systems in the City of Los Angeles. This criterion evaluates our client’s ability to navigate bureaucratic constraints and to implement changes based on the AIDS Coordinator’s Office’s jurisdiction and available resources.

Technical feasibility: Navigation of Internal Constraints The AIDS Coordinator’s Office operates on a relatively small operating budget and staff. Similarly, the CBOs that our client seeks to assist in expanding rapid testing provision possess limited resources and funds. This criterion evaluates our client’s and CBOs’ abilities to institute changes in policies and practices that are reasonable, given these technical constrains.

104

Personal interview with Kevin Farrell, February 13, 2009.

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POLICY OPTIONS In this section, we propose two policy options to assist The City of Los Angeles AIDS Coordinator’s Office in realizing the City of Los Angeles HIV Testing Initiative’s stated goal of increasing the number of people who are aware of their HIV status. We identify a number of possible solutions (identified solutions) as means of implementing each policy option and then evaluate the solutions’ likelihood of success according to their political, structural, and technical feasibility.

In Policy Option No. 1 we explore ways to increase rapid HIV test provision. Although we ultimately advocate against pursing strategies to increase general screening (we do not believe it is the most effective way to meet the Initiative’s goal of getting one million people to know their HIV status), we evaluate possible solutions to regulatory impediments, per our client’s request.

In Policy Option No. 2 we explore ways to decrease the number of people who test preliminarily positive for HIV and fail to follow-up with confirmatory tests. By focusing on this issue, we believe that the AIDS Coordinator’s Office can more effectively advance the Testing Initiative’s goal of increasing the total number of people who are aware of their HIV status and fulfill the unstated objective of linking infected individuals to treatment and care.

POLICY OPTION No. 1: INCREASE THE NUMBER OF PEOPLE WHO ARE AWARE OF THEIR HIV STATUS BY INCREASING THE NUMBER OF HIV SCREENING TESTS PERFORMED Identified Solution No. 1: Work for change at the legislative level and reintroduce legislation that would remove LFS’s oversight of rapid HIV testing.

Political feasibility The history and fate of AB 1442 suggests that further legislation on this issue will unlikely survive LFS’s strong interest in maintaining oversight and control over each testing site’s quality assurance and general compliance with state-imposed counseling and testing regulations. Although the CDPH has officially expressed no position on this issue, the history of AB 1442 indicates policy makers’ resistance to implementing binding legislation on issues concerning HIV testing standards and practices. We therefore recommend against expending further time and resources on legislative action that would remove public health oversight from a state-level entity as politically powerful as LFS. Although it has been suggested that State OA is in the process of altering regulations that dictate the cumbersome CLIA waiver process, there is no public record to indicate that this change is imminent.

Additionally, our interviews with policy makers and CBOs indicate that this is not a general concern in the HIV/AIDS community.

Structural and Technical feasibility This identified solution is structurally and technically feasible in the sense that anyone has the right to pursue change via the legislative process; however, we recommend our client redirect focus away from attempting to change CLIA waiver regulation and legislation, due to insurmountable political constraints.

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Identified Solution No. 2: Hire a Licensed Laboratory Director and obtain a CLIA waiver under which CBOs can sub-contract.

AIDS Coordinator’s Office can avoid contending with the potentially steadfast legislative process and slowmoving regulation by hiring a medical director and applying for the City’s own CLIA waiver under which CBOs could sub-contract. This would allow new testing agencies to bypass the CLIA certification process that LFS mandates and avoid the high costs of maintaining a Licensed Laboratory Director.

Political feasibility This policy option, unlike Solution 1, is politically feasible because it would not disrupt the status quo and it does not affect State OA and LFS oversight.

Structural feasibility This policy option is structurally feasible because it would not require our client to overstep jurisdictional boundaries.

Technical feasibility This policy option may or may not be technically feasible due to the costs associated with the creation of a new position within the AIDS Coordinator’s Office (that of a Certified Laboratory Director). If this is an option that our client still wishes to pursue, we recommend conducting a cost-benefit analysis of the associated costs to the AIDS Coordinator’s Office and the savings to the CBOs. POLICY OPTION No. 2: INCREASE THE NUMBER OF PEOPLE WHO ARE AWARE OF THEIR HIV STATUS BY DECREASING THE NUMBER OF PEOPLE WHO TEST POSITIVE FOR HIV DURING SCREENING TESTS AND FAIL TO FOLLOW-UP WITH CONFIRMATORY TESTS Identified Solution No. 1: Support Regulatory and Legislative Action to Amend Phlebotomy Requirements for Rapid Finger-Prick Testing Assembly Bill 221, An act to amend Section 120917 of the Health and Safety Code, relating to public health, presents a useful vehicle for facilitating meaningful change at the regulatory level.

Although the CDC has not released official guidelines on the Rapid Testing Algorithm (RTA), the CDCfunded study in California and subsequent reports suggest that recommendations for the new algorithm are imminent. Testing sites that lack the resources to certify phlebotomists will be unable to integrate RTA into their practice. Therefore, Lab Field Services’ certification requirements must be altered so that California testing sites will be able to comply with forthcoming CDC guidelines.

Although a change in phlebotomy certification requirements is necessary for many current testing sites to implement RTA without incurring excessive monetary and time costs, legislative action is slow-moving and unlikely to translate into practice in time with CDC guidelines on new testing strategies. As previously Page | 29

discussed, AB 221’s passage through Sub-committees on Health and Business and Professions is essential for the bill to reach the floor for vote in September. In total, seven Assembly members serve constituencies in the Los Angeles area, each of whom possesses stake in the bill’s future.

The Assembly subcommittee on Health has four (out of 19) members who represent districts in the Los Angeles area: Hector De la Torre (50th District), Isadore Hall (52nd District), Edward Hernandez (57th District), and Bonnie Lowenthal (54th District).105 Their positions on this issue are unknown at this time.

The California Nurses Association (CNA) – an influential political force in health policy – has asserted opposition to the bill.106 According to the most recently published legislative analysis of AB 221, “CNA argues [the] bill erodes the minimal protections and certification that assure protection from blood borne diseases, and the 20 hours of training and 25 skin punctures are a small price to pay to assure safety and accuracy in testing.”107 The CNA, an affiliate of the AFL-CIO, currently represents more than 80,000 registered nurses at more than 170 facilities.108 Their support, or at least their avoidance of stringent opposition, is integral to AB 221’s success.

The CNA is made up of board member representation, divided by regions throughout the state. California Region 6 comprises ten hospitals and medical centers in the Los Angeles area: California Hospital Medical Center, Centinela Hospital Medical Center, Daniel Freeman Marina, Good Samaritan, Midway Hospital Medical Center, Mission and Community, Saint Vincent Medical Center, Santa Monica-UCLA Medical Center, USC University Hospital, USC Norris Cancer Hospital, and UCLA Medical Center.

SF AIDS Foundation and AIDS Healthcare Foundation, AB 221’s main supporters at the time of publication, are currently devising a strategy to secure the support of CNA. We recommend that our client join their campaign and actively lobby the Los Angeles-based members and attempt to ameliorate their concerns by addressing “the extent to which the current HIV counselor training covers infection control measures.”109 Political Feasibility This solution is politically feasible because AB 221 does not seek to remove California Department of Public Health (CDPH) (namely, Lab Field Services) oversight over quality assurance and professional standards. The bill’s language specifically exempts rapid HIV finger-prick test providers from phlebotomy requirements; it does not seek to remove the requirements for all forms of finger-prick tests. Positive testers would qualify for and get linked to treatment after the second rapid test, but would continue to submit to a Western blot test (after linkage to treatment, rather than waiting another week for the laboratory results). This practice would enable LFS to maintain at least partial oversight of testing activity and should therefore placate this influential government agency.

105 The

2009 subcommittee on Health: Jones (Chair), Fletcher (Vice Chair), Adams, Ammiano, Block, Carter, Conway, De La Torre, De León, Emmerson, Gaines, Hall, Hayashi, Hernandez, Lowenthal, Nava, Pérez, V.,Salas, and Strickland.

106 Telephone Interview with Israel Nevis, March 6, 2009; California Nurses Association, Legislative Advocacy, http://www.calnurses.org/legislative_advocacy/ (accessed on April 22, 2009) 107 AB221 Bill Analysis. http://www.assembly.ca.gov/acs/acsframeset2text.htm(accessed on April 22, 2009) 108 California Nurses Association, Facilities and Bargaining, http://www.calnurses.org/facilities-bargaining/ (accessed March 10, 2009).

109 AB221 Bill Analysis. At time of submission, we are not privy to the details of this strategy because they are currently in development.

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Structural Feasibility This solution meets the criteria for structural feasibility. Lobbying legislative bodies and special interest groups to effect legislative change lies within the AIDS Coordinator’s Office’s purview and does not require our client to overstep its jurisdiction.

Technical Feasibility This Solution also survives technical feasibility because it does not incur a high monetary cost to our client, nor does it include any immediate costs on the CBOs that the AIDS Coordinator’s Office seeks to assist. If AB 221 passes into law, the CBOs could potentially bear additional costs of training testing counselors to perform finger-prick testing. Currently, HIV test providers must undergo a CDPH-managed counselor training program.110 Because this bill seeks to integrate rapid finger-prick test training into the general HIV counselor training program, any indirect costs to our client and Los Angeles-based testing sites will be minimal However, these costs are marginal and would not greatly exceed current costs associated with training technicians to administer oral-swab test kits.

Identified Solution No. 2: Lobby for integration of a new rapid HIV testing policy in Los Angeles County In 2005, the San Francisco Department of Health (SFDH) implemented regulations that mandated all SFDH-supported testing sites to integrate RTA into practice. Over the past four years, SFDH-funded sites have practiced RTA and orchestrated positive testers’ direct linkage to treatment. We recommend that our client lobby for similar regulation in Los Angeles County for implementation in all County OAPP-funded sites.

Political feasibility Identified Solution No. 1 is politically feasible, but only if the AIDS Coordinator’s Office increases involvement in the Los Angeles County HIV Prevention Planning Committee (PPC), the local planning body that is federally mandated to effect this type of policy change. If our client can increase its influence within the PPC, it could gain entre into county-level regulatory and policy-making bodies. As was discussed earlier, the PPC oversees the direction of HIV prevention activities (including testing) within the County.

Given PPC’s mandate to assess available resources, analyze service gaps, and evaluate prevention needs, the AIDS Coordinator’s Office could successfully advocate for County OAPP’s adoption of a RTA policy by winning over this politically powerful regulatory body.

Under this solution, Lab Field Services would not have to relinquish its oversight of confirmatory Western blot tests. San Francisco testing agencies continue to forward positive testers’ blood and oral fluid specimens for confirmation by a Western blot test after a the administration of a confirmatory finger prick test. Although testers are deemed positive and linked to care immediately after a second positive rapid test, routinely performing Western blot tests after linkage facilitates LFS’ continued oversight. So long as a Los Angeles County policy provides for a similar protocol, a county-wide RTA policy could both reduce HIV counselor training requires four days of basic training, a two-day advanced training three months later, and one day of continuing training each year. AB 221 Bill Analysis.

110

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slippage and reconcile conflicting political interests (by satisfying LFS’ strong interests in maintaining quality control).

Structural feasibility The PPC comprises representatives from government, CBOs, advocacy groups, and health care providers who are selected to represent a wide variety of demographic groups affected by the epidemic. The AIDS Coordinator’s Office is a government agency and maintains close ties to community organizers and small CBOs throughout the city. The AIDS Coordinator’s (the Director of the AIDS Coordinator’s Office) enlistment in this committee is therefore appropriate and necessary to expand its scope of representation.

Technical feasibility Although this solution is technically feasible, Policy Option No.2 is not technically feasible for most CBOs operating County OAPP-funded sites while strict requirements for limited phlebotomy certification remain in force.

Oral-swab and finger-prick tests cost the same; however, under current phlebotomy regulations, the administrative costs associated with finger-prick tests are much higher than those associated with oral swab tests. Without changes in phlebotomy certification requirements for rapid finger-prick tests, this solution would incur a host of insurmountable costs on many testing agencies.

Under RTA, positive oral-swab tests are immediately confirmed with a rapid finger-prick test. The substantial time and monetary costs ancillary to training limited phlebotomists render the introduction of RTA into practice prohibitively expensive for most sites that only perform oral tests and budget for staff salary and training costs accordingly.

Identified Solution No. 3: Alert CBOs in the City of Los Angeles to the problem of slippage, increase the awareness of cutting-edge rapid testing practices, and prepare organizations to meet coming advancements in HIV testing.

In the short term – before the advent of a County OAPP-imposed RTA policy and changes to phlebotomy regulations– our client can achieve its goal of making one million people aware of their status by working with local CBOs to help to reduce the number of people who fail to submit for confirmatory testing or return for Western blot test results.

The AIDS Coordinator’s Office allocates funding to 14 CBOs that provide HIV testing services in the City of Los Angeles and can influence their testing practices. We propose the following strategies to both increase awareness of cutting edge RTA practices and to prepare organizations to meet coming advancements in HIV testing: 

Simply make providers aware of the slippage phenomenon. In several of our interviews, policy makers and service providers in Los Angeles were shocked when presented with the figures in Exhibit 6.

Providing CBOs with this information can allow them to make procedural adjustments within their own organizations to help decrease the number of HIV positive people who do not submit to confirmatory testing.

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

Decrease the overreliance on oral-swab testing by funding phlebotomy training for CBO staff members.

The high time and monetary costs of limited phlebotomy training, coupled with high staff turnover rates in many CBOs, prevent many testing agencies from paying for staff members to get certified as limited phlebotomists111 Using funds from the Testing Initiative, the AIDS Coordinator’s Office can create a grant, subsidy or loan program to help offset the costs of Limited Phlebotomy Certification. This strategy would 1) assist testing sites in keeping pace with RTA protocols in the event that the County implements a new rapid testing policy before AB 221’s passage and 2) help to wean providers off of relying upon the slightly less specific rapid oral swab test

Due to these recommendations’ relative simplicity and the AIDS Coordinator’s personal and fiscal relationships with CBOs in the City of Los Angeles, we believe that this solution meets all of the criteria for political, structural, and technical feasibility.

Nicea Brown at Minority AIDS Project explained that HIV test administrators are low-skilled, low-paying positions with high amount of turnover. Because the agency relies exclusively on oral swab testing, there is no incentive for them to hire Licensed Limited Phlebotomists.

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RECOMMENDATIONS This investigation initially sought to identify regulatory, legislative, and structural impediments to increasing the number of HIV screening tests performed in the City of Los Angeles. In the process of identifying such barriers we concluded the following:   

A developed and well-funded testing infrastructure in Los Angeles already exists and at least one million residents have recently been tested for HIV.112 Our investigation revealed an issue that is more critical to HIV status awareness than initial screening expansion: a phenomenon we have termed “slippage.”

Comparable metropolitan areas have implemented a new testing protocol into publicly-funded testing sites that has effectively decreased slippage and increased linkage to care and California’s unique phlebotomy regulations inhibit rapid testing sites from training phlebotomists and prevent providers in the City of Los Angeles from capitalizing on this latest evolution in HIV testing.

In response to these discoveries, we recommend that our client redirect focus away from strategies to increase the absolute amount of screening tests administered, and towards strategies for resolving the screening-to-confirmatory testing discrepancy. Although concerns for insufficient supply of testing provision and tangible regulatory roadblocks to increasing supply have merit, these concerns lack the evidence-based support necessary to pass political, structural and legislative muster. Furthermore, merely increasing the provision of screening tests, without addressing the salient issue of the testing discrepancy, is potentially inefficacious and could undermine the very purpose of screening for HIV- the immediate linkage of infected individuals to care. We therefore recommend the following to achieve The City of Los Angeles HIV Testing Initiative’s ultimate goals – to increase the number of people who are aware of their HIV status, ensure the provision of effective treatment regimen, decrease in spread of the disease, and ultimately, protection of the public health : 

Reframe the issue: meet the stated goal of increasing the number of people who are aware of their HIV status by redirecting the focus away from strategies to increase the provision of screening tests, and towards the issue of people who fail to submit to confirmatory tests and do not get linked to life-saving, behavior-altering treatment and care.



Increase Director-level participation in the Los Angeles County HIV Prevention Planning Committee: work with the group that is federally mandated to conduct evidence-based research on prevention strategies in Los Angeles and influence county-wide change. o Utilize the idea of slippage to effectively lobby for integration of RTA into County policy following regulatory change at the State level.



Support AB221: lobby Los Angeles-area legislators who sit on critical sub-committees and members of the California Nurses Association who wield political power and currently oppose legislation.

Getting people into testing has been identified as a major impediment to making people aware of their status. Because the first four goals of the Testing Initiative address this issue we will restrict our analysis to the supply side of HIV testing.

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We also recommend strategies that our client can pursue in the short term to both increase the awareness AND prepare organizations to meet the coming evolution in HIV testing: 

Raise provider awareness: draw attention to the discrepancies in testing submission among community based organizations that provide rapid HIV testing in the City of Los Angeles. Encourage leaders to implement procedural adjustments to help decrease the number of HIV positive people who do not submit to confirmatory testing.



Decrease providers’ overreliance on oral-swab testing: fund phlebotomy training for staff members of community based organizations. Using funds from the City of Los Angeles HIV Testing Initiative, create a grant, subsidy or loan program to help offset the costs of limited phlebotomy certification.

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APPENDIX A: GLOSSARY AB ACO AIDS CBO CDBG CDC CDPH CLIA CLIA waiver CMS CNA COMISSION COUNTY EPI COUNTY OAPP ELISA FDA HAART HIV HIV/AIDS HMO MD PLWA PLWHA PPC QA RTA SFDH Slippage SPA STATE LFS STATE OA STD TB

Assembly Bill City of Los Angeles AIDS Coordinator’s Office Acquired Immune Deficiency Syndrome Community Based Organization Community Development Block Grant Centers for Disease Control and Prevention California Department of Public Health Clinical Laboratory Improvements Amendments Clinical Laboratory Improvements Amendments Certificate of Waiver Federal Centers for Medicare & Medicaid Services California Nurses Association Los Angeles County Commission on HIV Health Services County of Los Angeles HIV Epidemiology Department County of Los Angeles Office of AIDS Programs and Policy Enzyme-Linked ImmunoSorbent Assay United States Food and Drug Administration Highly Active Antiretroviral Therapy Human Immunodeficiency Virus Used when distinction among the progression of disease is not relevant Health Maintenance Organization Medical Doctor People living with AIDS People living with HIV or AIDS Los Angeles County HIV Prevention Planning Committee Quality Assurance Rapid Testing Algorithm San Francisco Department of Public Health People who test positive during an HIV screening test and do not submit to confirmatory testing County of Los Angeles Service Planning Area California Department of Public Health Laboratory Field Services California Department of Public Health Office of AIDS Sexually Transmitted Disease Tuberculosis

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APPENDIX B: POLITICS OF HIV FLOW CHART

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APPENDIX C: LOS ANGELES COUNTY COMMISSION ON HIV HEALTH SERVICES MEMBERSHIP ROSTER

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APPENDIX D: TESTING INITIATIVE BUDGET (REDACTED)

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APPENDIX E: CITIES, COMMUNITIES, AND SERVICE PLANNING AREAS

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APPENDIX F: ASSEMBLY BILL 221 BILL NUMBER: AB 221 BILL TEXT INTRODUCED BY

INTRODUCED

Assembly Member Portantino FEBRUARY 4, 2009

An act to amend Section 120917 of the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL'S DIGEST AB 221, as introduced, Portantino. HIV testing: skin punctures.

Existing law permits the Office of AIDS in the State Department of Public Health to participate in a rapid HIV test research program conducted with the federal Centers for Disease Control and Prevention. Under this program, HIV counselors trained by the Office of AIDS in the State Department of Public Health may perform skin punctures for purposes of withdrawing blood for test purposes, if the HIV counselor meets prescribed requirements. One of these requirements is that the HIV counselor must hold a valid certification as a phlebotomist technician by the State Department of Public Health.

This bill would exempt an HIV counselor who is trained by prescribed personnel and in accordance with training requirements established by the department, and who works under a licensed physician and surgeon, from the requirement that he or she hold a valid certification as a phlebotomist technician.

Vote: majority. Appropriation: no. Fiscal committee: yes.

State-mandated local program: no.

THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. The Legislature finds and declares all of the following: (a) The United States Centers for Disease Control and Prevention estimates that HIV incidence is 40 percent higher than previously thought. (b) The Office of AIDS in the State Department of Public Health estimates that between 30,000 and 40,000 Californians are unaware that they are HIV-positive and, therefore, are not receiving appropriate HIV treatment and are possibly jeopardizing their own health, and that of their sex partners and intravenous drug-using partners. (c) It is therefore in the interest of the people of the State of California to take steps to ensure that people have greater access to HIV testing.

SEC. 2. Section 120917 of the Health and Safety Code is amended to read: 120917. (a) The department, through its Office of AIDS and the authorized agents of the office, may participate in a rapid human immunodeficiency virus test research program conducted with the

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federal Centers for Disease Control and Prevention, involving innovative HIV testing and counseling programs. Under the rapid HIV test research program, as authorized by this section, the department may do the following: (1) Perform and report clinical test results using a rapid HIV test for diagnosis, prior to test approval by the federal Food and Drug Administration (FDA). However, test performance and reporting shall only be done to the extent allowed under that device's investigational approval by the FDA and pursuant to a California Health and Human Services Agency Institutional Review Board-approved research protocol.

(2) Use a second independent HIV test to confirm initially reactive test results to the extent allowed under the investigational approval by the FDA. All rapid tests shall be confirmed using technology approved by the federal Food and Drug Administration. If the results from this confirmatory testing differ from the results of the rapid test, the subject shall be notified. No subject shall participate in the research protocol who does not provide appropriate contact information. (b) An HIV counselor who is trained by the Office of AIDS and working in an HIV counseling and testing site funded by the department through a local health jurisdiction, or its agents, may do all of the following: (1) Perform any HIV test that is classified as waived under the federal Clinical Laboratory Improvement Act (CLIA) (42 U.S.C. Sec. 263a and following) if all of the following conditions exist: (A) The performance of the HIV test meets the requirements of CLIA and , subject to subparagraph (B), Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code.

(B) Notwithstanding Section 1246 of the Business and Professions Code, an HIV counselor may perform skin punctures for the purpose of withdrawing blood for HIV testing, upon specific authorization from a licensed physician and surgeon, provided that the person meets both of the following requirements: (i) He or she works under the direction of a licensed physician and surgeon. (ii) He or she has been trained in accordance with training requirements established by the department, by a licensed physician and surgeon, or by a licensed clinical laboratory scientist or bioanalyst in the proper procedures to be employed when conducting the skin puncture, and has a statement signed by the instructing physician and surgeon, scientist, or bioanalyst that the training has been successfully completed.

(B) (C) The person performing the HIV test meets the requirements for the performance of waived laboratory testing pursuant to subdivision (a) of Section 1206.5 of the Business and Professions Code. For purposes of this subdivision and subdivision (a) of Section 1206.5 of the Business and Professions Code, an HIV counselor trained by the Office of AIDS shall be "other health care personnel providing direct patient care" as referred to in paragraph (12) of subdivision (a) of Section 1206.5 of the Business and Professions Code.

(C) (D) The patient is informed that the preliminary result of the test is indicative of the likelihood of HIV infection and

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that the result must be confirmed by an additional more specific test, or, if approved by the federal Food and Drug Administration for that purpose, a second different rapid HIV test. Nothing in this subdivision shall be construed to allow an HIV counselor trained by the Office of AIDS to perform any HIV test that is not classified as waived under the CLIA. (2) Notwithstanding Sections 1246.5 and 2053 of the Business and Professions Code, order and report HIV test results from tests performed pursuant to paragraph (1) to patients without authorization from a licensed health care professional or his or her authorized representative. Patients with indeterminate or positive test results from tests performed pursuant to paragraph (1) shall be referred to a licensed health care provider whose scope of practice includes the authority to refer patients for laboratory testing for further evaluation. (c) Notwithstanding any other provision of law, an HIV counselor acting in accordance with this section who successfully completes the HIV counselor training shall be deemed to have demonstrated sufficient literacy and comprehension to advance to the limited phlebotomy technician training and may substitute successful completion of the HIV counselor curriculum for the requirement for a high school diploma or General Education Development (GED) equivalent for a limited phlebotomy technician, as defined in Section 1029.116 of Title 17 of the California Code of Regulations pursuant to Section 1246 of the Business and Professions Code. (d) An HIV counselor who meets the requirements of this section with respect to performing any HIV test that is classified as waived under the CLIA may not perform any other test unless that person meets the statutory and regulatory requirements for performing that other test.

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APPENDIX G: INTERVIEWS

Baker, Kyle. Director of Government Relations, County of Los Angeles Office of AIDS Programs and Policy, Los Angeles CA. Personal interview with Karen Parker and Lindsey Zwicker in Los Angeles, February 3, 2009.

Berry, Nicaea. Program Coordinator, Minority AIDS Project, Los Angeles, CA. Telephone interview with Karen Parker, March 6, 2009 Broadus, Carrie. Executive Director, Women Alive Coalition, Los Angeles, CA. Personal Interview with Lindsey Zwicker in Los Angeles, February 26, 2009 Curtis, Phil. Director, Government Affairs, AIDS Project Los Angeles, CA. Telephone interview with Lindsey Zwicker, February 26, 2009.

Dowling, Teri. Manager, HIV Counseling, Testing and Linkage Unit, San Francisco Department of Public Health AIDS Office, HIV Prevention Section, San Francisco, CA. Telephone interview with Karen Parker, March 6, 2009.

Engeran, Whitney. Director, Public Health Division for AIDS Healthcare Foundation, Los Angeles, CA. Personal Interview with Karen Parker and Lindsey Zwicker in Los Angeles, December 14, 2009.

Farrell, Kevin. Executive Director, Center for HIV Identification, Prevention and Treatment Services, Los Angeles, CA. Telephone Interview with Karen Parker and Lindsey Zwicker, January 23, 2009. Personal Interview with Karen Parker and Lindsey Zwicker in Los Angeles, February 13, 2009.

Landovitz, Raphael. Assistant Professor, Division of Infectious Diseases, Center for Clinical AIDS Research & Education University of California, Los Angeles. Personal interview with Karen Parker and Lindsey Zwicker in Los Angeles, January 26, 2009 McCallum, Donna. CLIA Laboratory Inspections, California Department of Health, Laboratory Field Services. Los Angeles, CA. Telephone interview with Lindsey Zwicker, February 6, 2009.

Mulhearn-Pearson, Courtney. Policy and Legislative Associate, San Francisco AIDS Foundation, San Francisco, CA. Telephone interview with Lindsey Zwicker, February 26, 2009.

Nevis, Israel. Director of Policy, HIV Prevention Section, San Francisco Department of Public Health.

Telephone interview with Karen Parker, March 6, 2009.

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Noledo, Ruell. Manager, State and Local Affairs, AIDS Project Los Angeles, CA. Telephone interview with Karen Parker and Lindsey Zwicker, December 16, 2009.

Perez, Mario. Director, County of Los Angeles Office of AIDS Programs and Policy, Los Angeles CA. Personal interview with Karen Parker and Lindsey Zwicker in Los Angeles, February 3, 2009.

Rosales, Ricky. Deputy City AIDS Coordinator, City of Los Angeles AIDS Coordinator’s Office.

Personal Interview with Karen Parker and Lindsey Zwicker, December 18, 2009. Email communication with Karen Parker and Lindsey Zwicker, February 10, 2009.

Rumanes, Sophia. Acting Director of Prevention Services, County of Los Angeles Office of AIDS Programs and Policy, Los Angeles CA. Personal interview with Lindsey Zwicker in Los Angeles, March 5, 2009.

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REFERENCES Alimonti, Judie B., et al. 2003. “Mechanisms of CD4+ T lymphocyte cell Death in Human Immunodeficiency Virus Infection and AIDS,” Journal of General Virology 84. 2003.

Branson, Bernard M. et al., “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings,” CDC MMWR 55, no. 14. 2006. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm (accessed February 3, 2009).

Calero1, E., et al., “Rapid HIV-1 Diagnostic Algorithms for Use in HIV Infection Screening,” The US Military HIV Research Program, Henry M. Jackson Foundation for the Advancement of Military Medicine 3091. September, 2006.

California Department of Public Health, 3-YR Expenditures and Positions (Summary of Program Requirements) http://www.ebudget.ca.gov/pdf/GovernorsBudget/4000/4265.pdf (accessed February 20, 2009) California Department of Public Health, Office of AIDS, CLIA-Waived Rapid HIV Testing, http://www.stdhivtraining.org/resource.php?id=191 (accessed March 9, 2009).

California Department of Public Health, Laboratory Field Services, http://www.cdph.ca.gov/programs/lfs/Pages/default.aspx (accessed January 20, 2009).

California Department of Public Health, Laboratory Field Services, “Phlebotomy Certification: Frequently Asked Questions,” http://www.cdph.ca.gov/programs/lfs/Documents/Phlebotomy%20FAQ071106.pdf (accessed March 1, 2009).

California Department of Public Health, Laboratory Field Services, Licensing and Certification, https://secure.cps.ca.gov/cltreg/pt_faq.asp (accessed March 1, 2009).

California Department of Public Health, Office of AIDS, http://www.cdph.ca.gov/programs/aids/Pages/Default.aspx (accessed January 25, 2009).

California Nurses Association, Facilities and Bargaining, http://www.calnurses.org/facilitiesbargaining/ (accessed March 10, 2009).

The Centers for Disease Control and Prevention, “CLIA Certificate of Waiver Fact Sheet,” http://www.cdc.gov/hiv/topics/testing/resources/factsheets/roltCLIA.htm (accessed March 15, 2009).

The Centers for Disease Control and Prevention, “HIV/AIDS: Basic Information,” Department of Health and Human Services, http://www.cdc.gov/hiv/topics/basic/index.htm#transmission (accessed March 15, 2009).

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The Centers for Disease Control and Prevention, “HIV/AIDSBasic Statistics,” Department of Health and Human Services, http://www.cdc.gov/HIV/topics/surveillance/basic.htm (accessed March 11, 2009).

The Centers for Disease Control and Prevention, “HIV/AIDS in the United States,” Department of Health and Human Services, http://www.cdc.gov/hiv/resources/factsheets/us.htm. (accessed March 11, 2009).

The Centers for Disease Control and Prevention, “HIV Testing,” Department of Health and Human Services, http://www.cdc.gov/hiv/topics/testing/index.htm. (accessed March 11, 2009).

The Centers for Disease Control and Prevention, “OraQuick Rapid HIV Test for Oral Fluid – Frequently Asked Questions,” Department of Health and Human Services, http://www.cdc.gov/Hiv/topics/testing/resources/qa/oralfluidqandafin.htmhttp://www.cdc.gov/Hiv/to pics/testing/resources/qa/oralfluidqandafin.htm (accessed March 15, 2009).

The Centers for Disease Control and Prevention, “Rapid HIV Testing,” Department of Health and Human Services, http://www.cdc.gov/Hiv/topics/testing/rapid/index.htm. (accessed February 3, 2009).

The Centers for Disease Control and Prevention, “Regulatory Oversight of Laboratory Testing Clinical Laboratory Improvement Amendments (CLIA),” CDC Consultation on Rapid HIV Testing September 10-11, 2002, http://www.cdc.gov/hiv/topics/testing/resources/reports/pdf/CLIA_Background.pdf (accessed March 15, 2009) Chavers, Constance, “HIV Counseling and Testing 2005-2006 Data,” OAPP PowerPoint Presentation, 2006, http://publichealth.lacounty.gov/aids/reports/PPC%20HCT%20Data%20Presentation%20 Oct%204%2007.pdf (accessed February 19, 2009).

City of Los Angeles AIDS Coordinator’s Office, “City HIV/AIDS Statistics,” http://www.lacityaids.org/hiv_stats.htm (accessed March 17, 2009).

City of Los Angeles AIDS Coordinator’s Office, “City HIV/AIDS Statistics,” Budget for the Fiscal Year 2008-2009. http://www.lacity.org/ctr/abu1/AdoptedBudget2008-09.pdf (accessed February 23, 2009).

City of Los Angeles, Policy on the HIV/AIDS Epidemic, Adopted by the Los Angeles City Council, October 16, 1990, http://www.lacityaids.org/documents/1990_policy.pdf (accessed March 9, 2009).

Committee Hearing on AB 1442, Senate Committee on Business, Professions, and Economic Development, June 6, 2007, http://info.sen.ca.gov/pub/07-08/bill/asm/ab_14011450/ab_1442_cfa_20070710_094846_sen_comm.html (accessed January 10, 2009).

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County of Los Angeles Public Health, “Knowledge and Perceptions of HIV/AIDS in Los Angeles County,” LA Health (December 2007), http://www.lapublichealth.org/ha/reports/HIV%20Brief%20-%20Final%20Draft.pdf (accessed January 20, 2009).

County of Los Angeles Public Health, HIV Epidemiology Program, HIV/AIDS Semi-Annual Surveillance Summary January 2009: Cases Reported as of December 31, 2008.

County of Los Angeles Public Health, Office of AIDS Programs and Policy, Los Angeles County Prevention Plan 2009-2013, http://publichealth.lacounty.gov/aids/PPC/Prevention%20Plan%2009/TableofContents.pd (accessed March 16, 2009).

f

County of Los Angeles Public Health, Office of AIDS Programs and Policies, Brochure, http://publichealth.lacounty.gov/aids/docs/OAPPBrochure.pdf (accessed February 16, 2009) County of Los Angeles Public Health, Office of AIDS Programs and Policy, HIV Counseling and Testing Annual Report (2007), http://publichealth.lacounty.gov/aids/reports/HCTCY2007ReportFinal.pdf (accessed January 26, 2009).

County of Los Angeles Public Health, Office of AIDS Programs and Policy, Overview of the PPC, http://publichealth.lacounty.gov/aids/hivplancomm.htm (accessed February 28, 2009).

County of Los Angles Public Health, Office of AIDS Programs and Policy, HIV Counseling and Testing Data, HIV Resources Information Systems (HIRS), Jan through Dec 2008. Unpublished, obtained via request.

County of Los Angeles Public Health, Office of Health Assessment and Epidemiology, 2007 Los Angeles County Health Survey. Unpublished, obtained via request.

Gates, Gary J., “Same-sex Couples and the Gay, Lesbian, Bisexual Population: New Estimates from the American Community Survey,” Williams Institute Study. October 2006.

Greenwald, Jeffrey L. et al., “A Rapid Review of Rapid HIV Antibody Tests,” Current Infectious Disease Reports 8. 2006.

Grusky, Oscar et al. 2006. "ZIP code correlates of HIV-testing: A Multi-level Analysis,” AIDS and Behavior 10(5).

King, JT, Jr, et al., “Long-term HIV/AIDS Survival Estimation in the Highly Active antiretroviral Therapy Era,” Medical Decision-Making 23(1), January-February, 2003: 921. “Late Versus Early Testing of HIV: 16 Sites, United States, 2000-2003,” CDC MMWR 55, no. 14 (2006), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5225a2.htm (accessed February 8, 2009).

Marks, Gary et al., “Meta-Analysis of High-Risk Sexual Behavior in Persons Aware and Unaware They are Infected With HIV in the United States: Implications for HIV Prevention Programs,” Journal of Acquired Immune Deficiency Syndrome 39. 2005.

Page | 48

Morgan, D., et al., “HIV-1 infection in rural Africa: is there a difference in median time to AIDS and survival compared with that in industrialized countries?” AIDS 16(4). 2002.

Mulhearn-Pearson, Courtney, Podcast, San Francisco AIDS Foundation, http://ga4.org/sfaf/notice-description.tcl?newsletter_id=30964987 (accessed February 22, 2009).

National Institute of Allergy and Infectious Diseases, “More on How HIV Causes AIDS, National Institutes of Health, http://www3.niaid.nih.gov/topics/HIVAIDS/Understanding/howhiv.htm (accessed March 10, 2009).

Rurangirwa, J., et. al., “Impact of a Rapid HIV Testing Algorithm on Receipt of HIV Testing and Referral to Medical Care.” PowerPoint presentation presented at American Public Health Association, 136th Annual Meeting and Exposition October 28, 2008.

San Francisco, AIDS Foundation, Update on Key HIV/AIDS Bills, http://www.sfaf.org/default.aspx?pid=1376&region=1&language=1 (accessed March 14, 2009).

U.S. Department of Commerce, Census Bureau, “State and County QuickFacts: Los Angeles (City), California,” http://quickfacts.census.gov/qfd/states/06/0644000.html (accessed February 6, 2009).

U.S. Department of Health and Human Services, Food and Drug Administration, “Assay for the Detection of Antibodies to Human Immunodeficiency VirusType 1, Including Group O (HIV-1 + “O”) and/or Type 2 (HIV-2),” ADVIA Centaur Assay Manual. 2006. http://www.fda.gov/cber/pmalabel/P050030LB.pdf (accessed March 6, 2009).

U.S. Department of Health and Human Services, Food and Drug Administration, “FDA’s Role in HIV/AIDS,” http://www.fda.gov/oashi/aids/fdarole.html (accessed March 17, 2009).

U.S. Department of Health and Human Services, Office of the Inspector General. Enrollment and Certification Processes in the Clinical Laboratory Improvement Amendments Program. August 2001.

Report OEI-05-00-00251. available at: http://www.hhs.gov/oigoei. (accessed February 27, 2009).

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