WRHI Annual Review by Linda Williams

Wits Reproductive Health & HIV Institute

ANNUAL REVIEW

2010-2011 | www.wrhi.ac.za

Vision To tackle Africaâ&#x20AC;&#x2122;s health challenges through science and innovation.

Mission As an internationally renowned African academic Institute and an agent of social change, our mission is to lead the way in the field of HIV, sexual & reproductive health and related conditions, and to be recognised for: Outstanding pioneering research Responsive technical support and quality innovative services Evidence-based policy development and advocacy Teaching and capacity-building Partnership with communities and stakeholders Commitment to our staff and creating a sustainable institute

Table of contents Foreword from the Executive Director �� 4 Message from the Dean of the Faculty of Health Sciences �� 6 Message from Wits Health Consortium �� 6 Provincial and Clinical Health Programmes �� 7 Overview �� 7 Background �� 8 District-based health systems strengthening �� 8 Programmes �� 10 Monitoring & Evaluation (M&E) �� 17 Research Programmes �� 18 Clinical research on new diagnostics and treatment in children �� 18 Clinical research on HIV treatment in adults �� 20 Clinical research on new diagnostics, vaccines and microbicides in adults �� 20 Research operations department �� 30 Community Programmes �� 32 Youth-friendly Services Project �� 32 Women at Risk (Sex Worker Project) �� 33 Men & HIV Project �� 33 Mobile Clinical Outreach Service �� 34 Community Care Centre �� 34 Fit for Life, Fit for Work �� 35 Paediatric, Adolescent & Caregiver Support �� 35 Hillbrow Health Precinct (HHP) �� 36 Background �� 36 Shandukani �� 36 Highlights for 2011 �� 37 WRHI Training Department �� 38 Overview of WRHI’s Training Department �� 38 External training �� 39 Internal training �� 40 Strategy and Development Department (SDD) �� 41 Introduction �� 41 Grants & Development �� 41 Strategy & Communications �� 41 Operations Department �� 43 Epidemiology and Biostatistics Department �� 44 Overview of the Epidemiology and Biostatistics Department �� 44 Study conceptualisation and design �� 44 Data analysis and publications �� 44 Data management support �� 44 Capacity-building �� 45 WRHI Leadership �� 46 Our Staff �� 49 Financial Review �� 50 WRHI Publications �� 51 WRHI Conference Presentations and Posters �� 53 WRHI Donors �� 56 A Brief History … �� 57 Abbreviations and Acronyms �� 58

ANNUAL REVIEW 2010-2011

Foreword from the Executive Director The Wits Reproductive Health and HIV Institute (WRHI) is one of the largest research institutes of the University of the Witwatersrand and part of the Faculty of Health Sciences. Established in 1994 as the Reproductive Health Research Unit (RHRU), the Institute was formed on 1 October 2010 through a merger with Enhancing Children’s HIV Outcomes (ECHO). Institute status was awarded by the University of the Witwatersrand in recognition of WRHI’s outstanding portfolio of research. In the same year, the RHRU’s KwaZulu-Natal operation was established as MatCH (Maternal, Adolescent and Child Health), housed in the Wits Health Consortium. From our beginnings 18 years ago we broadened our original portfolio focussing on sexual and reproductive health to include HIV research and health service provision, and later expanded further into a wider range of infectious diseases including sexually transmitted infections, tuberculosis and opportunistic infections. Today, WRHI has an extensive portfolio

embracing research, programmatic support, training, policy development, health systems strengthening and technical assistance at national and international level, becoming one of the largest organisations of its kind in Africa. The international standing of the Institute is reflected by its status as a World Health Organization Collaborating Centre for the Reproductive Health and Research Division of WHO. The Institute works with Government at a national, provincial and district level and has offices in Johannesburg, Ekurhuleni, Klerksdorp, Mafikeng, Emgwenya (formerly Waterval Boven, Mpumalanga) and Middelburg. Key research sites include Yeoville, Hillbrow, Emgwenya and Harriet Shezi Clinic at Baragwanath Hospital. We are proud to be a lead PEPFAR partner in these districts, building capacity and providing technical expertise in a health system under extreme pressure. WRHI conducts a broad range of research in the fields of infectious diseases (including HIV) and sexual, reproductive and maternal and child health. A special focus of this work is on strategies to prevent the acquisition, transmission or progression of HIV and other sexually transmitted infections. In 2010, with funding from the Dutch government, the WRHI established a dedicated specialised research site, the WRHI Research Centre in Hillbrow. This site has the capacity to recruit and retain hundreds of study participants on a monthly basis. The Research Centre is fully equipped to handle multiple research projects simultaneously. You can read more about our current studies in the ‘Research’ section of this review.

Helen Rees > Executive Director, WRHI

WRHI has always enjoyed positive relationships with the respective communities in which it works. All WRHI trials are supported by a strong social science programme that focuses on the social context of trial participants and their communities. Community Programmes work directly with vulnerable and marginalised groups within the

Wits Reproductive Health & HIV Institute

5 Johannesburg inner city, delivering health care, psychosocial support and education in a two-way engagement process that helps to inform our programmatic approach. Our head office is based in the Hillbrow Health Precinct, a unique collaboration of healthcare service providers formed by a partnership between the WRHI, the City of Johannesburg, Gauteng Department of Health, the private sector and the University of the Witwatersrand. Standing at the intersection of urban regeneration and community-based health care, the Hillbrow Health Precinct is a beacon of inspiration in the urban development landscape and a model of cooperation that is sure to see others follow in its footsteps.

Since inception WRHI has played a key role in influencing the reproductive health and HIV agenda at national level. Our strategies and activities are aligned with key priority areas at policy level and we actively engage Government and key stakeholders in policy discussions which are grounded in the rigours of scientific enquiry and evidence. The growth in scope and stature of the Institute has attracted a cadre of senior academics and health practitioners whose expertise spans the reproductive health, HIV, infectious diseases and social science fields, several of whom have national and international standing. In 2011, numerous staff across the Institute received a range of awards in recognition of their outstanding work. Selected major awards include: ›› Heath Clarke Lectureship at the London School of Hygiene and Tropical Medicine awarded to Prof Helen Rees

Helen with colleagues

our programmes. To meet the needs of an increasingly complex organisation, we have created new departments such as Strategy & Development and Research Operations, and strengthened the capacity of existing departments such as Training and Operations.

›› Desmond Kegakilwe was appointed Deputy Chair of RUDASA

WRHI has grown from nine people in 1994 to 600 in 2011. Our reach and influence extend beyond South Africa and we have become a globally recognised role player in HIV and sexual and reproductive health. We are now involved in multi-national research consortia and consulted by donors, policy-makers and the scientific community as experts in our field. We see ourselves as a proud African institution, committed to improving the health of South Africans and Africans through science, partnerships and advocacy.

›› Dr Thesla Palanee was appointed Co-Chair of the MTN-020 study of dapivirine gel effectiveness

Professor Helen Rees

With nearly 600 people employed, spanning four provinces, we have developed an efficient, responsive structure that enables us to provide the necessary institutional support and leadership to

Executive Director, WRHI

›› A European and Developing Countries Clinical Trials Partnership (EDCTP) Senior Fellowship awarded to Dr Sinead Delany-Moretlwe ›› The Wits University prestigious AJ Orenstein Memorial Lecture 2011 was delivered by Prof Francois Venter ›› The Faculty of Health Sciences prestigious lecture was delivered by Prof Helen Rees

ANNUAL REVIEW 2010-2011

Message from the Dean of the Faculty of Health Sciences The University of the Witwatersrand is known for its excellence and innovation in the health sciences. Much of our research attracts international attention and renown. Therefore it is a source of particular pride when we are able to confer the prestigious status of academic institute on a research entity. The RHRU and ECHO demonstrated, through their dedication and pioneering work in the field of reproductive health and HIV research, with both adults and children, that their newly merged organisation was worthy of this accolade. The formation of the Wits Reproductive Health & HIV Institute represents a major contribution to the research agenda of both South Africa and the African region. Furthermore, the technical support provided to the South African Government by the WRHI is consistent with the university’s principles of civic and community engagement for the betterment of all our citizens. The inspirational leadership shown by Professor Helen Rees and her colleagues is at the heart of the WRHI’s success and the Faculty is proud of the scale and scope of work undertaken by the many programmes within the Institute,

the impact of which is felt far beyond our shores. It is no exaggeration to say that many lives have been saved and improved as a result of the tireless work of WRHI staff. The field of health sciences is one of constant change and adaptation. In the field of HIV, where only 10 years ago effective antiretroviral treatment was beyond the reach of most people living with the virus in our country, researchers are now seriously investigating biomedical prevention technologies that offer real hope of stopping the epidemic in its tracks. The WRHI is at the forefront of many of these exciting initiatives. We wish Professor Rees and her team well as they face the future. Ahmed A Wadee Professor of Immunology Dean, Faculty of Health Sciences

Message from Wits Health Consortium Wits Health Consortium (Pty) Limited (WHC) is a wholly owned Company of the University of the Witwatersrand, Johannesburg under the Faculty of Health Sciences. WHC provides the Faculty with a legal framework within which to operate the research and other activities necessary to support its academic objectives. WHC comprises a number of syndicates, or research sites, which operate as divisions within WHC for administrative purposes whilst coming under the academic control of an appropriate Faculty department. The syndicates are managed independently within WHC, with discrete management structures determined by the syndicate directors. The Wits Reproductive Health & HIV Institute – WRHI – is our largest syndicate with a turnover of more than R300 million in 2011. The calibre of research conducted at WRHI has attracted worldwide attention and academic partnerships have been formed with global institutions. Directors and senior researchers regularly speak at international conferences. WRHI works closely with Government to strengthen the health system and a number

of senior staff are key players in national policy-making fora. WHC is tremendously proud of the achievements of WRHI and is pleased to be associated with such high-calibre, committed researchers and health care practitioners. We congratulate WRHI on the successful merger of RHRU and ECHO and the formation of the Institute. Alf Farrell

CEO, Wits Health Consortium

Wits Reproductive Health & HIV Institute

Provincial and Clinical Health Programmes Overview The Provincial and Clinical Health Programmes are provided through the District Approach to Systems in Health (DASH) in three provinces supported by WRHI. The aim of this programme is to improve delivery of quality health services for HIV and related conditions through a health systems strengthening approach. The programme includes: HIV prevention interventions through behavioural and biological technologies; appropriate, targeted HIV and TB case-finding through HIV counselling and testing and TB screening and testing; TB and HIV integration; appropriate management of HIV-positive adults and children, including the prevention and treatment of opportunistic infections, antiretroviral delivery and prevention of vertical transmission; and primary health care support thereby reducing HIV associated mortality and morbidity.

Objectives of the Provincial and Clinical Health Programmes To strengthen the capacity of the Department of Health and Social Development (DHSD) to reach the targets set out by the National Service Delivery Agreement – thereby increasing life expectancy, decreasing maternal and child mortality, combating HIV and AIDS and TB, decreasing the burden of disease from tuberculosis and strengthening the effectiveness of the health system. These objectives will be attained through: ›› Providing technical input to DHSD decision-makers to strengthen national, provincial, district and local health strategic plans. ›› Strengthening capacity of the DHSD staff to: ›› Facilitate evidence-guided management of health systems through appropriate monitoring, evaluation and reporting practices ›› Provide quality care for HIV and related conditions to adults, children, adolescents and pregnant women ›› Decrease TB transmission in communities by improving case-finding, diagnosis, infection control, treatment and cure rates ›› Understand and implement evidence-guided practices through the use of quality improvement methodology

›› Improve the outcomes and decrease mortality of HIV-positive women and their children by implementing all four prongs of the PMTCT programme ›› Expanding the existing knowledge base at the national, provincial, district and local level to ensure sustainability and scale-up of proposed interventions. ›› Encouraging a culture of learning by disseminating experiences and learning from others. ›› Conducting operational research to identify barriers to care or explore new ways of service delivery to improve health outcomes.

ANNUAL REVIEW 2010-2011

Health Programmes

›› Understand and implement HIV prevention strategies including but not limited to different models of HIV counselling and testing, medical male circumcision, post-exposure prophylaxis, prevention of vertical transmission (PMTCT)

8 Background WRHI has worked in partnership with the Department of Health (DoH) in the formulation of policy and delivery of HIV and sexual reproductive health services for many years at a national, provincial and district level. With WRHI staff spanning academic, clinical and the policy environment as well as having staff working within local metropolitan, district and provincial health facilities we have been well placed to support the National Department of Health (NDoH) strategically. For example, ongoing technical support is provided to the South African National AIDS Trust and the South African National AIDS Council (SANAC) Prevention, Treatment Care and Support, Monitoring and Evaluation and Research Technical Task Teams, as well as co-chairing the Programme Implementation Committee. WRHI has assisted in the development and writing of both the 20062010 and 2011-2015 National Strategic Plans for HIV, TB and STIs, as well as the current adult, paediatric and PMTCT HIV guidelines. WRHI has actively contributed to the development and implementation of the National Core Standards. In addition, we have been involved in the revision of the Contraception

Policy, formulating the new TB and HIV integration framework, and Primary Health Re-engineering policies. WRHI also provides technical support to the NDoH relating to disclosure and adolescent bio-psychosocial needs in healthcare. As a result of WRHI’s expertise in quality improvement, a WRHI senior member of staff, and expert in health systems strengthening and quality improvement, has been seconded to the Office of the Director General (NDoH) to assist with the implementation of the National Core Standards, and provide technical assistance with quality improvement across the provinces. Through working with the National Advisory Group on Immunisation (NAGI), WRHI supports the NDoH’s vaccine policies and provides technical support to the HPV vaccine strategy. WRHI also contributes to the National Data Advisory Committee. In terms of provincial and district coverage, WRHI has supported North West and Gauteng Province for many years and has recently initiated a programme to support Mpumalanga Province.

District-based health systems strengthening A structured approach

Health Programmes

Health Systems Strengthening (HSS) cuts across all programmatic areas. The main objective of the DASH programme is to strengthen the capacity and external stakeholders and facilitate evidence-based management of health systems through the use of practical quality improvement methodologies. Provision of quality improvement support and oversight through content knowledge, expertise, strategy and tools is also advocated. The Minister of Health’s Negotiated Service Delivery Agreement (NSDA) for the health sector emphasises the need for district health systems strengthening and quality improvement. To this end, WRHI has revised and updated one of its core quality improvement tools, the HIV Standards. The revised document (Quality of care Assessment Tool) reflects national priorities related to health systems strengthening. Since October

2010, WRHI’s District Quality Improvement teams have assessed 30 facilities using this tool. The results were shared with the facilities, and have been used as a framework to develop action plans to address gaps and improve services. WRHI has been actively involved in supporting the development

clinic reception

Wits Reproductive Health & HIV Institute

9 PROFILE OF PROVINCES Table 1 North West Province is a largely rural province with high HIV prevalence rates. WRHI supports three of four districts including Dr Kenneth Kaunda (DKK), Ngaka Modiri Molema (NMM) and Ruth Mopati (RSM) districts. These three districts have an estimated population of 2, 152 676 as shown in Table 1.

Districts

Gauteng Province is the most densely populated province in South Africa. WRHI supports three urban sub-districts including Ekurhuleni East (EESD), Ekurhuleni South (ESSD) and Region F (CoJ) sub-districts, with a combined population estimate of around three million. Owing to the highly mobile nature, in particular of people living within COJ, the exact population is difficult to predict but population estimates are shown in Table 1.

HIV prevalence

DKK

812 993

35.2%

NMM

871 228

28.2%

RSM

468 455

28.15%

Sub-districts

Population

HIV prevalence

Ekurhuleni East

993Â 157

27.8%

1,088 808

29.6%

800Â 000

30%

Population

HIV prevalence

Emakhazeni

48,503

24.8%

Steve Tshwete

160,252

33.4%

Ekurhuleni South Region F (CoJ)

Sub-districts

Health Programmes

Mpumalanga Province: In July 2011 WRHI initiated discussions with Emakhazeni District to support the district through the DASH programme. Through the PEPFAR realignment process, WRHI was allocated Emakhazeni sub-district, and together with the Foundation for Professional Development (FPD), Steve Tshwete sub-district the populations of which are shown in Table 1. WRHI started with a rapid assessment of the sub-districts and a team started working in October 2011.

Population

ANNUAL REVIEW 2010-2011

10 of the National Core Standards (NDoH – Office of Standards Compliance). The WRHI Head of Health Systems Strengthening and Quality Improvement, Winnie Moleko, has been seconded to the NDoH to assist with the implementation and scale-up of the national core standards and to provide provincial support for quality improvement interventions. WRHI teams are currently providing support to facilities in terms of using the National Core Standards as a tool for assessment and quality improvement. The district team’s primary role is to provide technical support to implement appropriate quality improvement methodologies, and encourage a culture of ongoing improvement. The

Institute for Health Improvement (IHI) has provided ongoing support for improvement initiatives across the districts in Gauteng and North West WRHI-supported sites.

Technical teams WRHI’s health DASH programmes work towards the provision of quality health services for HIV and related conditions in the three provinces through an ongoing process of quality improvement and health systems strengthening. There are two components to this approach: the Provincial Health Programmes which provide district quality improvement and the Clinical Health Programmes which provide technical and clinical support.

DASH Quality Improvement teams ›› Provincial/district support consists of WRHI quality improvement teams in each sub-district who report to a WRHI district manager. ›› The sub-district teams are composed of the following quality improvement mentors: ›› A monitoring and evaluation mentor based at the district health information system (HIS) office to work in alignment with district health information system (DHIS) team to improve data collection, review and report collation from DHIS ›› A regional mentor (Health Systems Mentor) who manages overall processes and the sub-district team ›› A clinical mentor who supports nurse initiation of antiretroviral therapy, adult and paediatric HIV care, PMTCT programmes and TB services ›› A prevention mentor who supports HIV counselling and testing (HCT); provider-initiated counselling and testing (PICT); TB/HIV integration; link to medical male circumcision (MMC); post-exposure prophylaxis, especially supporting sexual assault; and improving psychosocial response to patients ›› A data mentor who supports data quality, reviews indicators and directs DHIS mentoring ›› The district teams are headed by provincial managers ›› All districts are supported by technical teams: Technical teams consist of technical specialists in specific fields of HIV including paediatrics, adults, tuberculosis, maternal health, monitoring and evaluation, health systems strengthening, and prevention and counselling. Technical teams ensure ongoing high level expertise within the different technical areas and support districts to ensure that a good understanding of the different areas is maintained. They ensure that the latest national policies and guidelines are distributed, understood and implemented through district and sub-district teams. They support the development of training and IEC materials and implement research projects to understand barriers to effective implementation of optimal patient care.

Partnerships with DoH These teams integrate into the provincial, district and sub-district teams of the DoH. Work plans are shared to ensure alignment with those of the DoH, and WRHI is represented at district and provincial meetings to facilitate ongoing communication between respective structures.

Health Programmes

WRHI quality improvement teams visit facilities together with DoH district co-ordinators, and conduct quality improvement

assessments. There is an ongoing focus on the transfer of skills. WRHI teams work with the facility and sub-district management to address identified gaps, using methods such as training, mentoring, improvement of health systems, improvement of data systems, etc. Where additional support is required, the technical teams provide specialist assistance. The technical teams assist in designing and implementing training programmes, in developing quality improvement tools, mentorship, clinical assessments and in managing specialised clinics.

Programmes Prevention & access to care HIV counselling and testing: In response to the call by the Minister of Health to test 15 million people for HIV in South Africa, WRHI, in partnership with the DoH and other partners,

embarked on HIV Counselling and Testing (HCT) campaigns in Gauteng and North West Province. In addition to the campaigns, WRHI used mobile vans (one in North West and three in Gauteng) to extend HCT to those who could not readily access health services or be reached through the campaigns. The target

Wits Reproductive Health & HIV Institute

In addition to the HCT campaigns, WRHI conducted trainings on Provider-Initiated Counselling and Testing (PICT) in order to increase the number of patients tested. The PICT training includes a module dealing with the understanding, recognition and management of burnout, a contributing factor to stress and attitude problems in the healthcare setting. Counsellors are trained to offer quality counselling (including counselling for different age groups e.g. adults, adolescents and children; mental health; disclosure; adherence; and pre/post-test counselling). Debriefing sessions are held for all counsellors in facilities supported by WRHI to improve attitudes and staff wellness. District co-ordinators and managers are also trained to enable them to support counsellers during their supervision visits.

Quality Improvement interventions â&#x20AC;&#x201C; an example: WRHI, in partnership with DoH and other partners, has also been involved in supporting the collation of quality HCT data. An unexplained shortfall in reaching HCT targets resulted in WRHI conducting site visits to identify gaps in the data collection process. A backlog was identified due to a shortage of data capturers at sub-district level. Data capturers from WRHI were deployed to assist with this process, thereby improving both the system and the HCT statistics. The M&E Quality Improvement Mentors based at district offices have assisted in strengthening data management more generally.

Youth-friendly services: There has been emphasis on improving youth-friendly service provision in the areas in which WRHI works, and attempts are made to include it in the quality improvement package, with specific focus on HIVpositive young people. WRHI, in partnership with loveLife, will train service providers in Region F on youth-friendly services in 2012. (See Section 6: Community Programmes)

Tuberculosis The DASH TB intervention has involved the following strategies to improve TB outcomes and impact on the TB epidemic at community level:

TB prevention activities TB infection control: WRHI has conducted TB infection control baselines and assessments in all the facilities we support. The assessments were done using the WRHI TB Infection Control Assessment Tool as well as the DoH District Rapid Assessment tool (Drat). This was done with the participation of facility managers and sub-district managers. Action plans were drawn up and facilities assisted to address the gaps identified. From the second assessment, facilities had improved from an average of 37% to 57% compliance to the tool in both Gauteng and North West facilities, and facilities continue to improve in this respect.

Medical male circumcision: WRHI has been involved in training counsellors to include a discussion on MMC during counselling. Counsellors also support clients who have undergone MMC when they come to the clinics for a seven-day post-circumcision check-up. There are several high volume sites (Hillbrow CHC, and in NMM district), and WRHI works in partnership with the Johannesburg Metro District Management to identify ways to provide further support to these sites in 2012. Sexual assault: WRHI has focussed on the area of sexual assault over the past year. The intervention aims to improve the management of sexual assault, working in close partnership with local and provincial government. Issues dealt with include staff attitudes, psycho-social counselling, dealing with adults, adolescents and children, clinical management (including post-exposure prophylaxis), and monitoring and evaluation. WRHI has conducted specially designed training for doctors, nurses and counsellors respectively. This work has been developed in Gauteng and will be expanded to North West and Mpumalanga in 2012.

ANNUAL REVIEW 2010-2011

counting out ARVs prior to dispensing

specimens ready for lab

Health Programmes

for HCT in Johannesburgâ&#x20AC;&#x2122;s Region F was 90 905 and 99.7% was reached after one year in this sub-district. WRHI supported the HCT campaign in Ekurhuleni South and Ekurhuleni East. Although the targets were not reached, over 120Â 000 people were tested in these sub-districts. WRHI supported three sub-districts within the North West Province, where 1 269 people were tested.

12 INH prophylaxis: Evaluation of IPT figures, provision of training and material to monitor adherence and completion of IPT. In both the North West and Gauteng supported sites the isoniazid prophylaxis uptake has improved although uptake is still below 50% and the teams are working hard to improve this. Screening of persons for TB to detect early disease (Intensified case-finding): Review of adherence to TB screening in facilities.

TB case-finding improvement TB case-finding is being supported through: ›› Roll-out of the new National TB Guidelines. ›› Quality improvement through the implementation and compliance to the TB programme guidelines. ›› Facility-based review of TB indicators, with facility mapping to identify facilities that require assistance (Primary Health Care; Community Health Clinics and hospitals). ›› Exploring strategies to improve TB case-finding: ›› Evaluation of a tool for community health workers to use

in home visits to TB clients. This simple, easy to use tool (Ask, Answer, Advise) is being piloted to facilitate homebased TB screening, HIV counselling, home TB infection control and general health assessment. Case-finding rates and user/receiver acceptability are being assessed. ›› Evaluation of paper slips for enhanced case-finding of contacts of TB cases in Region F is being conducted. All TB cases (new and prevalent) are to be given a ‘business card’ slip to pass on to their contacts inviting them to attend clinic for evaluation if symptomatic with cough, loss of weight or night sweats. The number of slips given out is recorded. The number of TB suspects returning with slips and the number of TB cases diagnosed amongst those suspects is recorded using the modified TB case register.

TB and HIV integration HIV and TB fuel each other’s epidemics and it is vital that TB patients are screened for HIV and initiated onto ART and for HIV-infected patients to be screened for TB. WRHI has been working with facilities to encourage the integration of TB and HIV services. This has included training. There have been significant improvements, for example: in Ekurhuleni East we have seen an increase in TB cure rate to 88% which is above the target of 85%. This is largely due to the collaboration of partners working together in Ekurhuleni. WRHI has developed an HIV/TB facility-based integration manual in close collaboration with Médecins Sans Frontières (MSF) and NDoH. An important focal point has been NIMART training, emphasising ART for TB patients. A high proportion of HIV patients are screened for TB in Region F. We also see a high proportion of TB patients tested for HIV (Figure 1).

Management of complex tuberculosis patients With the assistance of WRHI’s Technical Team, the Charlotte Maxeke Academic Johannesburg Hospital (CMJAH) provides appropriate HIV and TB referral support to primary care clinics in the area. WRHI assists in the provision of specialist support for patients with complex and/or co-morbid conditions. These sites have become major centres for clinical teaching.

Health Programmes

Strategies to improve TB detection and diagnosis Tuberculosis diagnosis has a low sensitivity and takes time for culture results to become available. New molecular diagnostic tests have become available with the potential to provide point-of-care diagnosis. WRHI is currently evaluating the use of the Gene Xpert MTB/Rif machine at point of care in Region F of City of Johannesburg Primary Health Care facilities, with a pragmatic comparison between both individual and TB programme indicators. Of the 14 PHC facilities in Region F,

Wits Reproductive Health & HIV Institute

13 seven are able to host the machine. The TB Case Investigation Register has been adapted to assist with the measure of outcomes, and includes additional parameters so that the benefit of using the Xpert MTB/Rif can be quantified between those facilities using the machine, and those remaining with laboratory-based testing, be it conventional or Xpert.

Adult and paediatric care and treatment In order to increase the number of patients on appropriate and effective antiretroviral therapy (ART) whilst reducing loss to follow-up from pre-ART and ART care, WRHI, through its district technical support teams, has undertaken the following activities:

NIMART (Nurse Initiated Management of Antiretroviral Therapy) A NIMART mentoring framework was developed by WRHI in October 2010, which looked at all the requirements for supporting the NIMART process introduced by the DoH in April 2010. This framework was introduced into all facilities supported by WRHI. Facility managers were trained on the WRHI NIMART framework and facilities were then assessed in preparation for delivering NIMART. NIMART training was provided to nurses identified by facility managers. All trained nurses receive ongoing mentoring from WRHI, and in-service training is provided to reinforce the training and to ensure the provision of quality care. NIMART TRAINING – Total nurses trained in 2011 (Total = 607) COJ – 100 NMM – 257 Ekurhuleni – 37 RSM – 126 Dr. KK – 87 Figure 1: TB indicators, JHB Metro District Q1-Q4 2011 100

100%

95%

Q1 Q2

Q3 70%

Q4 Target

60 50% 40

0 % TB cases tested for HIV (ETR) per quarter

% TB cases HIV+ per quarter

% HIV + TB % HIV + TB % TB cases cases with cases initiated with contact CD4 per on ART per tracing done quarter (ETR) quarter (ETR) (new)

% HIV + cases % HIV+ cases % HIV+ cases screened for found to have without TB TB (DHIS) TB disease symptoms started on IPT (DHIS)

ANNUAL REVIEW 2010-2011

In Region F (City of Johannesburg), all 14 PHC facilities initiate adult patients, and three of these also initiate paediatric patients through NIMART. The number of patients initiated per quarter at these facilities has increased from 137 in the first quarter to 708 in the fourth quarter in 2011. Based on HCT figures, the clinics are approaching the DoH target of an 80% initiation rate. In Ekurhuleni, 31 facilities initiate adult patients on ART and seven initiate both adult and paediatric

Health Programmes

›› ›› ›› ›› ››

14 patients. In Dr. Kenneth Kaunda 35 facilities initiate adult patients and seven initiate paediatric patients; only three facilities in the district are not yet initiating ART. In Ngaka Modiri Molema, 47 facilities (80%) are initiating ART. In the sub-district of Ratlou, all facilities are initiating ART. In RSM, 175 patients were initiated on ART through NIMART up until the end of quarter three.

Specialist ART care and treatment The Adult Care and Treatment Technical Team also assists with consultation of patients at specialist ART sites in Region F. ART research projects A number of research projects have been undertaken. A study determining whether providing immediate CD4 cell count results at HIV testing would improve ART initiation was published in the Journal of Acquired Immune Deficiency Syndrome (JAIDS). This was also presented at IAS and the 5th Interest Workshop. Another study on the impact of CD4 cell count delivery by SMS on retention in care has been completed. A poster on this was presented at SAAIDS. Further, three posters have been presented on various aspects of NIMART at South African AIDS Conference.

Paediatric technical team The WRHI Paediatric Technical team provides support and mentorship to districts for paediatric care. This includes

workshops for nurses and doctors; in-service training and mentoring; and responding to specific requests to assist with the management of problem cases. Support is also provided to the district-based quality improvement mentors in downreferring/transferring children from hospitals to clinics, in the hope that this will capacitate clinic staff and increase their confidence in initiating children. Decentralising care for the management of paediatrics also serves to decongest the hospitals so that they can increase focus on more specialist care. In addition the paediatric team supports training of the graduate entry medical programme (GEMP) 1, 3 and 4 students attending University of Witwatersrand with lectures, preparation and marking of examination papers and on-site training with the Harriet Shezi Children’s Clinic team. The team also supports the Continuing Professional Development (CPD) Programme at Chris Hani Baragwanath Academic Hospital with scheduled lectures at the paediatric department meetings.

Harriet Shezi Children’s Clinic Harriet Shezi Children’s Clinic focuses on paediatric, preadolescent and adolescent HIV services encompassing disease management, psychosocial support groups and counselling. From October 2010 until December 2011, there were 18 898 visits to the clinic with 635 of these being first visits. To date 4 135 children have been initiated onto ART at the children’s clinic. A process of down-referral to PHCs is in place, in step with the trend towards decentralised care to free the clinic to manage more complex patients. The re-organisation of the clinic to allow dedicated days for pre-adolescents and adolescents has been very successful in improving psychosocial services at the clinic. Topics and issues that are more suited to the different age groups can be discussed on the appropriate days. (0-12 years for the pre-adolescents and 13 years and above for adolescents). The attendance at both weekly support groups has been steadily growing. Each month between 20-30 youth attend the support group on Thursdays.

Health Programmes

Masakhane weekend support groups:

patients wait to be seen at Harriet Shezi Clinic

The Masakhane weekend support groups help consolidate and allow further discussions around varying themes ranging from safe sex, sexuality, adherence, hygiene and self-respect to effective study techniques for exams, to name but a few. Masakhane is held fortnightly on Saturdays with an average attendance of about 30 adolescents. The majority of participants are from Soweto but a few come from Orange Farm, Natalspruit and some are from places of safety. Most participants are in early adolescence, with an equal number of males and females. Two camps were held during the year and covered a broad range of self-help topics such as self-defence. Subsequent reports from adolescents have shown integration of these skills into their daily lives.

Wits Reproductive Health & HIV Institute

15 An average of 1 000 counselling sessions are held monthly at the clinic. Defaulters remain a challenge in the clinic. However, the monthly defaulter rate has dropped from about 6% at the start of the reporting period to 4% at the end. Part of the role of the counsellors is to follow up on these defaulters and bring them back into care. We have only had one loss to follow-up in the year. Harriet Shezi Childrenâ&#x20AC;&#x2122;s Clinic provides the base for several operational and clinical research activities. The clinic is a research site of the NIH-funded IMPAACT clinical trials network. There are currently eight clinical trials being conducted at the clinic. In addition there are a number of investigator-driven trials, including a study exploring the issue of immune reconstitution in children. (See Section 5.)

counselling room

Maternal health The aim of this programme is to strengthen the capacity of DoH staff to improve health outcomes and decrease the mortality of HIV-positive women and their children by implementing all four prongs of the PMTCT programme. These are: (i) Primary prevention of HIV, especially among pregnant women and young people (ii) Prevention of unintended pregnancies among HIV-positive women (iii) Prevention of HIV transmission from HIV-positive women to their children (iv) Treatment, care and support to HIV-positive women and their families.

A lay counsellor operates the geneXpert machine

Support for the revision and implementation of the PMTCT guidelines (2010): WRHI supported the NDoH in the development of the revised NDoH PMTCT guidelines. Based on the new guidelines, WRHI assisted in the development of training material in collaboration with other PEPFAR partners, and provided training and mentorship to DoH staff on the implementation thereof. All facilities within the five districts WRHI supports are implementing the new guidelines. NIMART: WRHI has provided support to a number of facilities to initiate NIMART within antenatal clinics. In this regard, we have seen a reduction in HIV transmission across all provinces in which we work, which was verified by the MRC survey showing Gautengâ&#x20AC;&#x2122;s mother-to-child HIV transmission at six weeks to be 2.3% and North West to be 4.5%, as figure 2 illustrates overleaf. It has also been shown that HIV-associated maternal mortality has reduced within the inner city of Johannesburg, highlighting the benefits of integrated HIV and maternal programmes.

A counsellor explains the ins and outs of ART to a client

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HIV counselling and testing of pregnant women: Testing pregnant women for HIV remains high in North West, Gauteng and Mpumalanga. However, only 35% of women report before 20 weeks of gestation. The team continues to engage facilities and clients in addressing late access to antenatal care. Some of the reasons mentioned by clients for attending services after 20 weeks gestation include the booking systems, working, not knowing that they are pregnant early in pregnancy as well as waiting times.

checking babyâ&#x20AC;&#x2122;s heart rate

16 Figure 2: Early infant diagnosis of HIV in NMM District, North West Province, 2011 600

Total PCR test 2mo+

Total PCR test <2mo

500 4%

Estimated infants exposed

3% 300 2%

200

100

PCR positive rate

Number of PCRs

400

PCR positive rate <2mo

HIV testing uptake is good, ranging from 88-95%, although the target is 100%. We intend supporting the districts in the next year to approach this target. A focal point is the improvement of data collection and reporting to the DHIS, supported by mentorship for relevant staff. The DASH team is involved in quality improvement site visits and methodology to improve the gaps in the PMTCT programme. The elimination of mother-to-child transmission has been prioritised by the North West Department of Health, and to this end, WRHI’s North West team, particularly NMM district, has been extensively involved in the development of the North West Provincial Department of Health’s EMTCT (Elimination of Mother to Child Transmission) framework.

Health Programmes

Fertility management for HIV-positive women: The maternal health team has identified that contraceptive provision for HIVpositive pregnant women is sub-optimal. Strategies are being evaluated to improve integration of family planning services into HIV services. Additionally WRHI staff have played an active role in the revision and updating of the National Contraceptive Policy. The new policy should be implemented in 2012. There has been a lack of information on how to manage HIVaffected couples who wish to conceive on how to conceive and minimise HIV transmission to their partner and infant. The Maternal Health team facilitated the development of pre-conception guidelines for HIV-affected couples which were published through the HIV Clinician’s Society in 2011. The Maternal Health team has also assisted in the development of guidelines on reducing mother-to-child HIV transmission when invasive obstetric procedures need to be performed. Supporting paediatric care

Wits Reproductive Health & HIV Institute

17 Monitoring & Evaluation (M&E) Monitoring & Evaluation (M&E) activities and support are cross-cutting across WRHIâ&#x20AC;&#x2122;s programmes and teams.

M&E Portfolios The team has four main portfolios:

last year, support was provided to set up the database and analyse data for the HSS baseline assessments. Support was also provided to non-DASH teams for data collection, management, cleaning and other research-related activities.

Other M&E activities

The monitoring & reporting portfolio obtains monthly output data from the M&E mentors in the district and uses it for reporting to various stakeholders. The sources of data are the individual ART initiation site records and the DHIS. The data quality portfolio aims to improve the quality of data from the facility up to the relevant districts in all the areas that the DASH team supports. The team provides technical support and training to the sub-district- and district-based data quality and M&E mentors to ensure appropriate knowledge and skills sharing between WRHI and the DoH counterparts. In the last year WRHI has trained and mentored the DASH M&E and data mentors to conduct comprehensive baseline Data Quality Assessments (DQAs) in the various facilities in the DASH-supported districts. To date, the mentors have assessed 84% of facilities in NMM; 41% in DKK; 43% in RSM; 9% in Ekurhuleni; and 58% in Region F. The local teams plan to complete all the baseline assessments by end of quarter one 2012. Informal feedback to the individual facilities has been ongoing, along with relevant capacity-building activities as identified by the assessments. However, formal reports will be provided to the districts once all the sites have been assessed. This is planned for quarter two 2012.

In addition to the above portfolio activities, highlights of M&Eâ&#x20AC;&#x2122;s varied activities include: Mobile health (mHealth) project: The M&E team participated in the implementation of a new mobile health (mHealth) project funded by Vodacom and USAID. The team piloted three mHealth projects: pre-ART CD4 collection, ART adherence reminders and appointment reminders at Esselen clinic (in Hillbrow, Johannesburg), and is planning to roll out these initiatives to other WRHI-supported sites in Gauteng, North West and Mpumalanga provinces. The M&E team provides support to other mHealth projects where required. M&E training for Gauteng Department of Health (GDoH): WRHI received a request from the GDoH in quarter two 2011 to provide PMTCT-related M&E training to Gauteng facility managers and other staff. Five sets of three-day trainings each were provided in 2011, with over 80 participants. In-service support to WRHI: the M&E team provides ongoing support to other projects within WRHI. The M&E team has developed numerous reports for internal and external use, submitted abstracts and presented at various conferences, and has been published in Journal of AIDS.

The Health Management Information System (HMIS) portfolio supports the implementation and day-to-day functioning of the patient management systems at select WRHI-supported sites. The systems currently implemented by WRHI are Therapy Edge (TE) patient information system and the I-DART pharmacy dispensing system. In quarter four, 2011, WRHI was allocated the Ekurhuleni South sub-district as part of the PEPFAR district alignment process. As a result of this, WRHI took over the support of sites that were previously supported by Right to Care. A few of the sites had TE at the time of hand over. The portfolio is now also providing technical support to the TE staff at these sites. The Operations Research portfolio conducts and provides support to DASH team members in conducting operations research activities including programme evaluations. In the

ANNUAL REVIEW 2010-2011

Just some of the obstacles our rural teams have to contend with!

Health Programmes

WRHI has been supporting the DoH with the implementation of the three-tier ART monitoring system mandated by NDoH. M&E and QI team members have been participating in both the provincial and district tier implementation teams. Two of the five WRHI M&E mentors were trained in October 2011 as master trainers to support the DoH to roll out the system in the WRHI-supported districts.

Research Programmes WRHI’s research portfolio is designed to contribute to global evidence and cutting-edge research as part of an international effort in response to the HIV epidemic. A broad research programme focuses on HIV and related diseases, and sexual and reproductive health, within the context of different population groups including children, adolescents, and adult men and women. Clinical research on new diagnostics and treatment in children WRHI’s Paediatric Clinical Research Team is located at Harriet Shezi Children’s Clinic, Chris Hani Baragwanath Hospital. The team conducts clinical trials of new drugs and treatment strategies to

guide the care and management of HIV-positive infants, children, and adolescents, with a particular interest in TB/HIV co-infected children. The team conducts investigator-driven clinical trials and network trials through participation in the International Maternal Paediatric Adolescent Aids Clinical Trials Group (IMPAACT). During 2011, the team at Harriet Shezi Children’s Clinic participated in four IMPAACT protocols and two investigator-led clinical trials, as summarised below:

IMPAACT Protocols at Harriet Shezi Children’s Clinic P1020a: Phase I/II, Open-Label, Pharmacokinetic and Safety Study of Atazanavir in Combination Regimens in Antiretroviral Therapy (ART)-Naïve and Experienced HIVInfected Infants, Children, and Adolescents

Research Programmes

›› P1060: Parallel, Randomised, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention Of Mother-To-Child HIV Transmission ›› P1066: A Phase I/II, Multicentre, Open-Label, Noncomparative Study of the International Maternal, Paediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (MK-0518) in HIV-1 Infected Children and Adolescents (4 weeks-19 years) ›› P1070: Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to <36 Months of Age

Investigator-led clinical trials at Harriet Shezi Children’s Clinic

WRHI research pharmacy

›› Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children receiving Concomitant Treatment with Lopinavir/ritonavir (see next page) ›› The concentrations of efavirenz in South African HIVinfected children with and without rifampicin-based TB treatment

Wits Reproductive Health & HIV Institute

19 The Paediatric Clinical Research team supported the launch of PROMISE, a large-scale and complex IMPAACT clinical trial evaluating multiple PMTCT strategies and regimens, under the leadership of Prof. Ashraf Coovadia at our satellite site at Rahima Moosa Mother and Child Hospital.

of follow-up. The THINK study, led by Prof Annelies van Rie (University of North Carolina) and Dr Harry Moultrie, and funded by the NIH, was launched in 2009. More than 350 children have been enrolled into the cohort to date. Enrolment is expected to be completed in early 2013.

The team has a well-earned reputation for safely and effectively conducting intensive phase I/II pharmacokinetic and safety trials of new antiretroviral agents in children and infants. Team members sit on IMPAACT’s International Resource, Pharmacy Resource, Quality Assurance Committees, and a protocol committee of a study of a novel NNRTI agent.

The THINK study aims to estimate the incidence of TBIRIS in a cohort of children initiating ART at Harriet Shezi Children’s Clinic and to unravel the immunopathogenesis of paediatric TB-IRIS. A nested case-control study is being conducted to investigate the immunopathogenesis of TBIRIS, with a focus on cytokine expression measurements, lymphocyte subset immunophenotyping and assessment of the role of regulatory T cells. In order to improve the diagnosis of TB-IRIS, the study is evaluating the predictive and diagnostic value of QuantiFERON Gold in-tube, an FDA-approved interferon gamma release assay.

TB, HIV, IRIS, Nutrition in Kids Study (THINK) In October 2011, the first children exited the TB, HIV, IRIS, Nutrition in Kids (THINK) study after completing two years

WRHI research pharmacist checks medication

THINK Sub-study: Dosing, Safety and Pharmacokinetics of Rifabutin in Children Receiving Concomitant Treatment with Lopinavir/Ritonavir A sub-study of the THINK protocol is assessing dosing, safety and pharmacokinetic profile of rifabutin, a rifamycin used in adults in the United States to overcome drug-drug interactions, when given concomitantly with lopinavir/ritonavirin in young children. HIV-associated tuberculosis is difficult to treat because of drugdrug interactions, particularly in children where a protease inhibitor is used as part of first-line antiretroviral therapy. Rifabutin offers an attractive alternative to rifampicin as part of tuberculosis therapy for those receiving lopinavir/ritonavir, as rifabutin has little effect on protease inhibitor concentrations. A major barrier to use of rifabutin in young children is the lack of dosing, safety, and efficacy data. WRHI, in collaboration with Prof Annelies van Rie from University of North Carolina, is conducting an open-label dose-finding study of rifabutin in children ≤ 5 years old who recently completed TB treatment and are receiving an ART regimen containing two Nucleoside Reverse Transcriptase Inhibitors and lopinavir/ritonavir. The study, funded by the National Institutes for Health, has garnered much interest from international organisations including the Drugs for Neglected Diseases Initiative and the Clinton HIV/AIDS Initiative. So far six children have been enrolled and completed pharmacokinetic assessments. Results are expected to be released in early 2013.

THINK Sub-study: Evaluation of GeneXpert in children

WRHI research lab technicians

In late 2011, Shobna Sawry, the WRHI THINK project manager, commenced a sub-study to evaluate the sensitivity and specificity of the GeneXpert MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampicin resistance in paediatric pulmonary and extra-pulmonary TB samples. The study will evaluate samples from 1400 HIV-positive children.

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Research Programmes

Notable achievements of the team and staff members during 2011 include a successful European Medicines Agency audit and a PhD awarded to Michelle Viljoen, one of our collaborators, for her exploration of the pharmacokinetics and pharmacogenetics of efavirenz in South African children which was conducted at Harriet Shezi Children’s Clinic.

20 Clinical research on HIV treatment in adults

SPARTAC: Short Pulse Anti Retroviral Therapy at HIV Seroconversion (Full title: Short Pulse Anti Retroviral Therapy at HIV Seroconversion: a multicentre randomised trial of therapeutic intervention at primary HIV-1 infection) The SPARTAC trial was a collaborative network trial. It was the largest randomised control trial ever undertaken in primary (recent) HIV infection. The study ran between 2003 and 2011 across eight countries. SPARTAC examined whether treating people recently infected with HIV (within six months of infection) with anti-HIV drugs for a short period of time could slow down the damage caused by HIV to the immune system and consequently delay the need to start long-term ART. SPARTAC recruited 366 adults, mainly heterosexual women and men who have sex with men, from 35 sites in Australia, Brazil, Italy, U.K. and Ireland, Uganda and South Africa. WRHI contributed 30 participants to this trial. Specifically, SPARTAC used a combination of anti-HIV drugs including Combivir (a combination drug of zidovudine and lamivudine) with lopinavir or a low dose of ritonavir (commercially called Kaletra). SPARTAC compared participants recently infected with HIV, who were randomly assigned to one of three treatment groups:

›› a group given a short course of treatment for 12 weeks (SCART) ›› a group given a long course of treatment for 48 weeks (LCART) ›› a group not given treatment immediately but therapy was delayed according to current local standards of care Summary of results: The trial results revealed that giving participants recently infected with HIV LCART (48 weeks) delayed the time to reaching CD4 <350 or starting long-term treatment, compared to the SCART or no ART groups. Overall this effect was more obvious when LCART was started closer to the time of HIV infection. The LCART cohort had lowered viral loads and decreased CD4 counts. No benefit was found when giving SCART to participants recently infected with HIV. There was no evidence of harm from either the LCART or SCART groups, and the participants’ response to long-term ART was not affected. Although SPARTAC did not specifically look at this question, in addition to benefiting individuals recently infected with HIV, the lower level of virus in the blood in participants treated with LCART would impact current reduction in risk of passing on the virus from the participant to a sexual partner. The study was funded by the Wellcome Trust and was part of an international collaboration led by the Chief Investigator, Professor Jonathan Weber at the sponsor, Imperial College London, together with the University of Oxford, the Medical Research Council Clinical Trials Unit (MRC CTU), and participating clinical partners in Australia, Brazil, Italy, Spain, South Africa, Uganda, and the U.K. and Ireland.

Clinical research on new diagnostics, vaccines and microbicides in adults

Research Programmes

HPV prevention research Cervical cancer is the most common cause of cancer in women of reproductive age in South Africa, and is caused by a common sexually transmitted infection, Human Papilloma Virus or HPV. HPV is also the cause of genital warts, other anogenital cancers and head and neck cancers in men and women. Research has shown that people who are infected with HIV are more likely to have higher rates of HPV infection, to be infected with multiple HPV types, particularly high-risk types which cause cancers. WRHI’s research agenda on HPV is aimed at developing evidence to assist policy-makers on key questions about cervical cancer prevention in South Africa.

CANVAS: Cancer Vaccine Acceptability Study Two vaccines effective against HPV types 16 and 18, the types which cause 70% of all cervical cancers, were registered in South Africa in 2008. Although registered for use in South Africa, the HPV vaccine is not yet available in the South African public sector. The WHO has recommended the inclusion of

HPV vaccination into national immunisation programmes, provided that the cervical cancer burden is a public health priority, that sustainable financing is secured, that programme delivery is feasible, and that cost-effectiveness is considered. Despite a screening programme implemented 10 years ago, cervical cancer is still the leading cause of cancer in women of reproductive age in South Africa. Primary prevention through vaccination represents an attractive option for South Africa. Currently cost is a key consideration, but it is not the only consideration. Recent experiences with introducing pneumococcal and rotavirus into the existing Expanded Programme on Immunisation (EPI) programme have highlighted the importance of considering the feasibility and logistics of introducing a vaccine programme for an age group not traditional targeted by EPI. WRHI’s CANVAS research team conducted a cross-sectional, qualitative study in Gauteng and North West Provinces to assess feasibility and acceptability of introducing the HPV vaccine for adolescents in South Africa. In-Depth Interviews

Wits Reproductive Health & HIV Institute

Knowledge of HPV and the link to cervical cancer was poor. Vaccine acceptability was high but was premised on concerns about sexual and reproductive health among adolescents and familiarity with childhood immunisations, rather than HPV itself. This was reflected in discussions of age at vaccination as well as potential promotional messages. Overall, there was support for a schools-based programme targeting adolescent girls. Integration with other adolescent health interventions was acceptable but preference for interventions was site-specific. Acceptability was not influenced by whether the vaccine was promoted as an STI or a cancer prevention vaccine. Providers were more likely to discuss issues of feasibility, but only key informants engaged with issues of coverage, duration of immunity and cost when making recommendations. A future public-funded HPV vaccine programme will need to provide clear educational messages about the link between HPV infection and cervical cancer, and options for prevention. A schoolsbased programme is likely to yield high coverage, especially if linked to other priority adolescent health interventions.

HARP: HPV in Africa Research Partnership Interest in cervical cancer prevention in developing countries is mounting, more so since the advent of the two highly effective HPV vaccines. However, before these vaccines can impact on cancer rates many years into the future, there will still be a need to organise affordable and sustainable cervical cancer screening programmes that can reach many women at risk. The development of simplified HPV screening tests holds great promise for cervical cancer prevention, particularly for high-risk women such as those who live with HIV. Given that high-risk HPV infection is common in HIV-positive women, there are concerns that as ART access expands and womenâ&#x20AC;&#x2122;s lives are spared, they may become at increased risk of death due to another preventable disease, cervical cancer. HARP is the first study of the simultaneous evaluation of currently existing cervical cancer screening strategies against histological endpoints conducted among HIVpositive African women. This is also the first rigorous evaluation of CareHPV in an African setting.

A detailed report of the results of this study are available on request. We are currently planning a project to pilot the delivery of HPV vaccination as part of a schools-based vaccination programme.

The HARP Consortium consists of several leading academic institutions including WRHI, the London School of Hygiene and Tropical Medicine, the University of Montpellier in France and the University of Ougadougou in Burkina Faso. The 42-month project is funded by the European Union and will work in Burkina Faso and South Africa, two countries representing two very contrasting health infrastructures and HIV epidemics, yet facing similar challenges in terms of cervical cancer prevention and care. In South Africa, the National Health Laboratory Service is a key partner in this project. The HARP project is expected to answer key questions around the delivery of a future cervical cancer screening programme in South Africa, specifically identifying cost-effective cervical cancer detection strategies in HIV-positive women in Africa, which should lead to improved coverage of cervical cancer screening in our country and ultimately

HARP â&#x20AC;&#x201C; one of our network clinical trials

collecting samples for clinical trials

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(IDIs) (n=91) and Focus Group Discussions (FGDs) (n=14) were conducted with learners, parents, teachers, health-care providers and key informants. Four FGDs and 35 IDIs were conducted with learners aged 9-19 years. Parents gave consent for their minor children to participate, and young people gave their assent. Health care providers in both provinces participated in focus group discussions and completed a pairwise ranking exercise to compare and prioritise interventions for inclusion in an adolescent package of care. Ten options were suggested, including male circumcision, screening for hearing and vision, and information about substance abuse.

22 improved survival and quality of life for HIV-positive women.

HIM-SA: Human Papillomavirus in Men – Natural History of Human Papillomavirus (HPV) Infection and Disease in HIV-1 Seropositive Men in South Africa HPV is also the cause of a substantial burden of morbidity and mortality in men, yet much less is known about the natural history of genital HPV infection and disease in men than in women, particularly in low and middle income countries like South Africa. HPV causes genital warts, and penile and anal cancers in men. HPV has also been implicated as a cause of some head and neck cancers in men. As with women, HIV is likely to influence the development of HPV-associated disease, leading to increased rates of anal or penile cancers and of anogenital warts. ART should reduce HPV warts by restoring the immune response against HPV. Theoretically, access to ART and restoration of immune function may have a beneficial effect by slowing down or preventing the development of pre-cancerous lesions in men. Research in women has shown mixed results with some studies indicating a benefit of ART on the development of HPV-associated disease, whilst others have not found the same benefits of ART on regression of lesions .

greatest. HIV prevention trials are challenging and little is known about men’s participation in HIV prevention research. Much of the literature concerning clinical trials focuses on populations who are considered to be marginalised or stigmatised, such as women, the elderly and ethnic minorities, leaving the study of male volunteers ignored. Many of the HIV prevention interventions under investigation have been targeted at women who are considered to be at higher risk for infection and arguably at greater need for more femalecontrolled methods of HIV prevention. Research conducted with women taking part in clinical trials in South Africa has shown that women participate to learn about their own health, and to access care and support which is not readily available to them in the public health sector. Further research is needed amongst male populations to determine whether these observations apply to male volunteers. WRHI’s research team is currently conducting a study to assess the feasibility and acceptability of enrolling migrant men into a future Phase III HIV vaccine trial in inner city Johannesburg

The quadrivalent HPV vaccine which protects against HPV types 16/18/6/11 represents a great hope to curb incidence of cervical cancer of women; and trials have now shown that there may be benefits to vaccinating young men or boys. In areas of high HIV prevalence such as South Africa, vaccination of men who have sex with men, and possibly heterosexual men for their own benefit, should make sense, but the cost of the vaccine remains an important limitation for programmes. This study is aimed at providing additional local data on the prevalence and incidence of HPV-associated disease in men, and the cost-effectiveness of including boys in an HPV vaccination programme. The study will also attempt to answer important questions about the management of HPV disease in men. This study is funded as part of a European and Developing Countries Clinical Trials Partnership Senior Fellowship award, and includes partnerships with the London School of Hygiene and Tropical Medicine and the National Health Laboratory Service.

HIV prevention research: vaccines

Research Programmes

AfrEVacc: African-European HIV Vaccine Development Network Historically, vaccines have impacted significantly on the spread of infectious diseases such as smallpox, polio, measles and yellow fever. Despite the expansion of ART, and the potential for treatment to reduce HIV transmission if sufficient coverage is achieved, an effective HIV preventive vaccine represents the best long-term hope for ending the HIV pandemic. There is a need to develop and test preventive vaccines in Africa in high-risk populations where the HIV epidemic is

WRHI research lab technician

Wits Reproductive Health & HIV Institute

CHAVI: The Centre for HIV/AIDS Vaccine Immunology CHAVI involves a consortium of investigators led by Duke University and the University of North Carolina. CHAVI is testing new vaccine strategies to overcome key immunological roadblocks in HIV vaccine design. These roadblocks include a lack of understanding of the correlates of protective immunity to HIV-1 and a lack of vectors and immunogens that can induce protective, durable immune responses at mucosal sites. CHAVI is studying the transmitted virus and the biological events that occur during transmission in individuals acutely infected with HIV. At WRHI, we have screened a total of 4 431 people and identified 39 individuals with acute HIV infection for further study. Follow-up of participants is ongoing.

HIV prevention research: oral and topical preexposure prophylaxis

study participantâ&#x20AC;&#x2122;s attendance is recorded using the latest technology

A major proportion of the Instituteâ&#x20AC;&#x2122;s HIV research work has focussed on women, based on the rationale that women have borne the brunt of the epidemic due to a complex mix of biological susceptibility, social and economic vulnerability and behavioural factors.

What are microbicides? Although correct and consistent use of male condoms has been shown to prevent HIV, women are not always able to negotiate their use. Women desperately need methods for preventing HIV that they can control themselves. ARV-based prevention methods, such as vaginal gel, oral tablet or vaginal ring, are promising approaches. WRHIâ&#x20AC;&#x2122;s HIV prevention research portfolio includes studies considered among the most important for advancing the field of HIV prevention. Many of these trials are focused on assessing ARV-based microbicides and include studies designed to evaluate microbicides along with other promising HIV prevention approaches, such as the daily use of ARVs as pre-exposure prophylaxis (PrEP). Microbicides are antimicrobial products which prevent the transmission of sexually transmitted infections including HIV. Microbicides offer those women unable to negotiate condom use the means to protect themselves against HIV. Microbicides could be used alone or in combination with barrier methods to block the sexual transmission of HIV. Even a partially effective microbicide has the potential to have a profound impact on HIV transmission rates globally and impact on the dynamics of the HIV epidemic.

Characterisation of Novel Microbicide Safety Biomarkers in East and South Africa The ideal microbicide decreases the risk of HIV infection while preserving the integrity of the cervicovaginal epithelium. Traditional approaches for evaluating novel microbicides have failed to predict the safety for initially promising, potent and safe antiviral compounds. More data is needed on potential biomarkers of safety in women, particularly women from sub-Saharan Africa where microbicides are needed and where parameters of safety may be influenced by co-infection with other sexually transmitted infections or different hormone exposures as a result of pregnancy or contraceptive use. This study aims to characterise the vaginal environment with respect to the vaginal microbial flora; biomarkers of epithelial integrity; and soluble and cellular biomarkers of immune activation, including target cells for HIV in HIV-negative adult women in good health at low risk of HIV in four different groups. These groups are: low-risk HIV-negative women; pregnant women; adolescents; and women who engage in vaginal practices considered to be high-risk. This study is a collaboration between partners at WRHI, International

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Research Programmes

using Hepatitis B vaccine as a surrogate for a future HIV vaccine. While there is no proven HIV vaccine, we have the opportunity to explore the acceptability of vaccination using a surrogate vaccine and to explore whether vaccination itself is an incentive to participation in trials. The use of a surrogate vaccine allows evaluation beyond the hypothetical acceptability of an HIV vaccine and to compare the experiences of those who receive a vaccine with those that do not. It is anticipated that the results of this research will be useful for preparing for a future HIV vaccine trial. In the absence of an HIV vaccine candidate for evaluation in Phase III trials, it is anticipated that this research will still provide useful data for other HIV prevention trials involving men, as well as future trials of vaccines for sexually transmitted infections other than HIV, such as hepatitis B and HPV. Initial analyses have been presented at the European and Developing Countries Clinical Trials Partnership Forum in Addis Ababa, Ethiopia and show that the population in this study represents a high-risk cohort which could be enrolled into future HIV vaccine trials. Complete results of this study will be available in 2012.

24 Centre for Reproductive Health (Kenya), Project Ubuzima (Rwanda) and European partners at the Institute of Tropical Medicine and the University of Ghent, and is funded by the European and Developing Countries Clinical Trials Partnership. To date all sites have enrolled the planned 430 participants, and follow-up is ongoing. Final results will be presented at a symposium planned for October 2012.

Intravaginal Practices, Bacterial Vaginosis, and HIV Infection in Women: Individual Participant Data Meta-analysis In a related study, WRHI investigators contributed data to a meta-analysis of individual participant data from 13 prospective cohort studies involving 14 874 women to investigate the association between intravaginal practices and acquisition of HIV infection among women in sub-Saharan Africa. The study showed that intravaginal use of cloth or paper, insertion of products to dry or tighten the vagina, and intravaginal cleaning with soap were independently associated with HIV acquisition. The results were published in an article in PLOS Medicine.

Network trials in prevention research Through our participation in a range of network clinical trials, WRHI continues to actively engage with studies that explore the biological and socio-economic factors leading to susceptibility, and to contribute to the global HIV research agenda.

study drugs in the research pharmacy

What are network trials?

Research Programmes

Network trials are collaborative research efforts that link central sponsors with research groups across a diverse array of specialisations and international and national geographical areas to secure answers to a defined set of research questions in a standardised manner. The study protocol outlines the exact methodology with which to seek answers to the research question. Trials are implemented in a consistent manner with a minimal level of variability across clinical trial sites, pre-approved by the central protocol leadership. Network trials are usually randomised control trials (RCT) where an intervention is compared to a matched placebo control. Allocation to a specific arm of the study is usually by chance. Due to these diverse collaborative linkages, network trial sites are selected based on relevance to the community in which they are conducted. Data is usually combined across trial sites for primary analyses. Multiple sites allow for secondary analyses of the interventionsâ&#x20AC;&#x2122; safety and effectiveness in diverse geographical, ethnic, and cultural contexts. To date, WRHI has engaged in network trials focussing on HIV prevention and treatment with sponsors from the U.S., U.K. and now S.A. consortiums.

processing samples in the research lab

Wits Reproductive Health & HIV Institute

25 FACTS: The Follow-on African Consortium for Tenofovir Studies

FACTS is a newly-created South African research consortium established to conduct clinical studies to determine whether tenofovir gel is safe and effective at protecting women from HIV and herpes simplex virus (HSV-2). FACTS is the first ever African-led and -implemented multi-centred trial of an HIV prevention technology. It is the first time that South Africa’s Departments of Science &Technology and Health, with USAID and the Bill & Melinda Gates Foundation, have supported a large national trial of this nature.

FACTS 001 is a large-scale, randomised placebo-controlled clinical study designed to test the safety and effectiveness of vaginal tenofovir gel used before and after sex to protect women against HIV infection and also against HSV-2, a virus that causes genital herpes. The study will enrol a minimum of 2 200 HIV-negative women aged 18-30 years at nine sites in South Africa. The trial aims to confirm the results of CAPRISA 004, a smaller trial in 899 women which showed that 1% tenofovir gel reduced HIV infection by 39% in women. FACTS 001 is a pivotal trial aimed at providing sufficient data for licensure of tenofovir gel for use by women at risk of HIV infection in South Africa. Prof Helen Rees is protocol chair and Prof Glenda Gray the co-chair. The consortium includes several other South African investigators based at the Aurum Institute, the Desmond Tutu HIV Foundation, MatCH, the Medunsa Clinical Research Unit, the Qhakaza Mbokodo Research Clinic, and the Setshaba Research Centre. In addition to supporting the core functions of the consortium, WRHI is also enrolling participants at a site in Yeoville, Johannesburg.

(USAID) and the South African Department of Health. CONRAD and Gilead Sciences, Inc. are providing the study products.

Microbicide Trials Network

The Microbicide Trials Network (MTN) is a U.S. National Institutes of Health-funded worldwide collaborative clinical trials network focussing on the prevention of the sexual transmission of HIV through the development and evaluation of products that reduce the transmission of HIV when applied topically to mucosal surfaces, when taken orally or when inserted intravaginally. The MTN’s scientific portfolio includes studies to determine PrEP safety and effectiveness with different dosing strategies, formulations and new drugs in both domestic and international populations. WRHI is currently partnering with the MTN on a range of these studies. These include the MTN 003 (the VOICE Study); MTN 015 (an Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials); and MTN 016 (Evaluation of Maternal Baby Registry Outcomes after Chemoprophylatic Exposure). These are described below:

FACTS 002 is an adolescent safety study designed to test the safety and acceptability of tenofovir gel in 16- and 17-year-old South African young women. WRHI will be conducting the FACTS 001 trial only but will receive support from FACTS CORE. In October 2011, five sites in Cape Town, Johannesburg, Soweto, Rustenburg and Pretoria began screening women, and the first study participants were enrolled. Results are expected in 2014. FACTS 001 is sponsored by CONRAD and funded by the South African Department of Science and Technology, the U.S. Agency for International Development

MTN 003: The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic. This involves 5 029 women at 15 trial sites across Uganda, South Africa and Zimbabwe. WRHI contributes 354 women to the VOICE study that is evaluating the safety and effectiveness of

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Research Programmes

The FACTS Consortium is currently conducting two HIV prevention studies – FACTS 001 and FACTS 002. WRHI is the base for FACTS CORE and the co-ordinating centre for more than seven collaborating FACTS trial sites.

26 two different approaches for preventing sexual transmission of HIV in women as well as determining which of the two regimes women are more likely to follow: taking an ARV tablet once a day (PrEP) or applying an ARV-based vaginal microbicide daily. VOICE is the only trial evaluating the daily use of an ARV tablet â&#x20AC;&#x201C; an approach called oral pre-exposure prophylaxis, or PrEP â&#x20AC;&#x201C; and a vaginal gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women prefer. The VOICE study data was reviewed in September and October 2011, where NIAID Prevention Trials Data Safety Monitory Board (DSMB) determined that it was not possible to show whether oral tenofovir tablets or tenofovir gel were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomised to the oral tenofovir tablet group and gel group discontinue their use of the study products. Results for the remaining Truvada arm of the trial are anticipated in 2012.

blind, placebo-controlled Phase 3 trial that will start in quarter three of 2012. Study products are the Dapivirine Vaginal Ring (VR) and the placebo VR. The Protocol Co-chair for ASPIRE is Dr Thesla Palanee, the Director of Clinical Trials at WRHI. This multicentre trial plans to enrol 3 476 women across 19 trial sites in South Africa (Johannesburg, Durban and Cape Town), Uganda, Zimbabwe, Malawi and Zambia. The IND (Investigational New Drug) sponsor is the International Partnership for Microbicides.

HIV prevention research: interactions between hormonal contraception and HIV WRHI has had a long-standing interest in the interactions between hormonal contraception, HIV and HIV treatment. In 2011, several studies were completed and/or published highlighting the influence of hormonal contraception on HIV transmission, as well as the potential effects of HIV treatment on contraceptive efficacy. Several new projects are also in development aimed at addressing these questions further.

MTN 015: An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials MTN-015 is a long-term, observational study that seeks to understand the nature of HIV progression and treatment response in HIV-positive women who become infected incidental to their participation in an HIV prevention trial of either a topical microbicide or oral PrEP. The study will help better understand the impact of these agents on the natural history and clinical course of HIV. Importantly, MTN015 will help address theoretical questions about HIV drug resistance in the context of ARV-based prevention.

MTN 016 Evaluation of Maternal Baby Registry Outcomes after Chemoprophylatic Exposure MTN-016 is a first-of-its-kind registry of women who become pregnant while participating in an HIV prevention trial of either a microbicide or an oral antiretroviral drug. The registry, which is in development, will help determine the effects, if any, that early exposure to these products may have on foetal and/or neonatal development.

Research Programmes

In the pipeline: ASPIRE: A Study to Prevent Infection with a Ring for Extended Use

MTN 020 :ASPIRE: ASPIRE is a multi-centre, two-arm, randomised (1:1), double-

colposcope with camera

Wits Reproductive Health & HIV Institute

27 Interactions between Antiretrovirals and Combined Oral Contraceptive Pills Evidence from small pharmacokinetic studies suggest that selected antiretroviral drugs that induce liver enzymes, particularly protease inhibitors and non-nucleoside reverse transcriptase inhibitors like nevirapine, may reduce the levels of hormones in oral contraceptives (COC), potentially reducing their contraceptive efficacy. In partnership with FHI, WRHI conducted a study to evaluate the contraceptive effectiveness of COCs in women taking oral contraceptives concurrently with a nevirapine-containing ART regimen. Both ovulation and pregnancy rates were compared between women receiving both ART and COCs, and women taking COCs but not yet eligible for ART. Low rates of ovulation in the ART/COC group would imply that contraceptive effectiveness is not impaired in women taking nevirapinecontaining ART, and warrant increased promotion of oral contraception for pregnancy prevention in HIV-positive women. Enrolment and follow-up of participants was completed in 2011, and data analysis is currently ongoing.

Research on structural and behavioural interventions STRIVE RPC: Research Programme Consortium Tackling the Structural Drivers of HIV Numerous commentators have called for increased attention to the social and economic forces that exacerbate HIV

vulnerability, but few donors, governments or agencies have fully responded to this challenge. The reasons are myriad: addressing structural determinants of HIV, such as gender inequality, labour migration or homelessness, requires intervening beyond the health sector and extensive collaboration across disciplines and ministries. Tackling such issues is often seen as a secondary priority or as someone elseâ&#x20AC;&#x2122;s responsibility, resulting in inadequate investment. Moreover, due to the methodological challenges, few programmes targeting structural drivers have been rigorously evaluated, leaving a weak evidence base. The STRIVE RPC aims to overcome these barriers by promoting rigorous research into what works to tackle the structural determinants of HIV, and will maximise learning from interventions that have effectively influenced policy and taken such approaches to scale. Specifically, STRIVE concentrates on four interlocking structural drivers, including gender roles and inequalities (including violence and masculinities); stigmatisation, discrimination and criminalisation; poor livelihood opportunities; and unrestricted alcohol availability and drinking norms. Through this consortium, STRIVE partners aim to conduct research which will deepen the fundamental understanding of structural factors and pathways that increase HIV risk; evaluate the impact and cost-effectiveness of structural interventions; advance methods for evaluating structural interventions; and enhance insights into policy influence and processes of change. Led by London School of Hygiene and Tropical Medicine, partners in the consortium include WRHI in South Africa, Mwanza Intervention Trials Unit in Tanzania, and Karnataka Health Promotion Trust and the International Centre for Research on Women in India. The STRIVE RPC is funded by DFID.

research nurse

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Gender-based violence has serious consequences for pregnant women and their unborn infants, including increased risk of HIV infection. In partnership with colleagues from the WHO, WRHI is examining the feasibility and acceptability of integrating a brief intervention for women experiencing intimate partner violence into routine ANC visits. The study will be conducted

Research Programmes

Preventing intimate partner violence during pregnancy

28 in three public sector clinics in the Johannesburg inner city. Formative work will establish how best to tailor an existing intervention to the South African context. Thereafter a Phase I pilot of the intervention will be conducted in order to improve the safety, empowerment, mental health and help-seeking behaviours of pregnant women experiencing intimate partner violence. Evaluation of the intervention will test whether it is possible to reduce the recurrence, frequency and severity of intimate partner violence during pregnancy and whether the intervention modifies HIV risk behaviours. This project is linked to the STRIVE RPC outlined above.

Adolescent health focus WRHI has had a longstanding interest in adolescent sexual and reproductive health, ever since the completion of the national adolescent survey on HIV and sexually transmitted infections in 2003, a population-based survey of young people in South Africa aged 15-24 years. Several new projects were initiated in 2011 which focus on adolescent health interventions delivered in or in relation to schools, interventions to improve linkages to health services, and studies to address the particular biological vulnerabilities of adolescents to disease. HPTN068 or SwaKoteka

Research Programmes

SwaKoteka is an innovative multi-level structural intervention for the prevention of HIV infection in young South African women. Premised on evidence from cross-sectional data showing the protective effect of school attendance on HIV infection, the study is a collaboration between Dr Catherine MacPhail at WRHI, Prof. Kathy Khan at MRC/Wits Rural Health Transitions and Public Health Research Unit (Agincourt), and Dr Audrey Pettifor at the University of North Carolina, Chapel Hill. Young women and one of their parents living in the Agincourt Demographic Surveillance site in rural Mpumalanga are randomised to an intervention in which they receive a cash transfer conditioned on school attendance. The cash transfer is benchmarked on the current Child Support Grant with the major difference being that 1/3 of the payment is made directly

to the young women. The study is in the process of enrolling 2 660 HIV-negative young women and following them for three years with primary outcomes being HIV and HSV-2 incident infections. In tandem with the cash transfer, villages in the areas are randomised to receive a community mobilisation intervention targeting young men as the potential sexual partners of young women. The community mobilisation aims to challenge gender norms to generate reductions in intimate partner violence and concurrent partnerships and increased condom use. The study is funded by the HIV Prevention Trials Network, the National Institutes of Health and RENEWAL. Results are expected in 2015 and if found to have a positive impact on HIV incidence would lead to recommendations to government on potentially conditioning the Child Support Grant on school attendance.

New project: Feasibility of cash transfer intervention in complex urban environments Following on from HPTN 068 or SwaKoteka, we plan to explore further the role of poverty in driving HIV risk in South Africa. Together with collaborators from Johns Hopkins School of Public Health, we will conduct a survey among both in- and out-of-school youth aged 16-24 years living in a low-resource urban setting such as Hillbrow, Johannesburg. Data from the survey will be used to pilot a direct cash incentive aimed at promoting the use of health services and reducing transactional sex. This study will provide important information on the appropriate delivery mechanisms by

briefing the research team

Wits Reproductive Health & HIV Institute

Grassroot Soccer: Randomised controlled trial evaluation of the Generation Skillz curriculum Identifying effective and scaleable adolescent-targeted HIV prevention interventions remains an urgent public health priority, particularly in South Africa, which has the highest 15-24-year-old HIV prevalence in the world. Strong evidence exists to suggest that well-designed school-based HIV prevention interventions can improve knowledge and reduce reported sexual risk behaviours, though no such interventions have demonstrated an effect on HIV incidence. Interest in sport as a tool for health promotion has grown substantially. Previous observational studies have demonstrated promising short-term effects of sports-based HIV prevention (SBHP) interventions targeting adolescents, but no randomised controlled trials of interventions have been conducted to date. In collaboration with Grassroot Soccer and the London School of Hygiene and Tropical Medicine, WRHI will undertake a cluster-randomised trial to evaluate the Grassroot Soccer SBHP intervention in Soweto, Khayelitsha and Port Elizabeth, South Africa. The trial will enrol 12 000 Grade 9 students in 60 schools. Surveys assessing knowledge, gender norms, reported attitudes and reported behaviours will be collected at baseline, 12, 24 and 36 months; and biological outcomes (HIV and HSV-2) will also be assessed at baseline and 36 months. A mixed-methods process evaluation and costeffectiveness assessment will be carried out alongside the trial, and a nested trial within this trial will assess whether biweekly SMS messages enhance the intervention’s effect. This trial will play an important role in guiding adolescenttargeted HIV prevention policy, strategy and funding, not only within South Africa but across sub-Saharan Africa.

WAVE: Well-being of Adolescents in Vulnerable Environments WAVE is a six-city global study of young people in vulnerable environments with the goal of discovering ways to connect youth to health. The study, led by investigators at Johns Hopkins School of Public Health, aims to provide a picture of the state of adolescent health and access to health services across the globe and to lay the groundwork to understand youth connections to health and its regional and gender-based differences. The six study sites are: Johannesburg, South Africa; Baltimore, USA; Shanghai, China;

Delhi, India; Rio de Janeiro, Brazil; and Ibadan, Nigeria. The study makes use of innovative survey techniques to gather data on how and where adolescents tap into health information services. To ensure the study is meaningful to young people and those who work with young people, the research team has partnered with youth and community advisers to collect in-depth information about the state of adolescents in each community and the availability of health services and resources. This research will be followed by a cell phone-generated survey of 400 teenagers in each site. WAVE aims to lay the groundwork for interventions incorporating cell phone and social networking technology to improve access to health for young people. Data collection was initiated in 2011.

Adolescent Risk-taking Behaviour and Psychosocial Health Survey The purpose of this study is to explore the sexual risktaking behaviour, psychosocial health and health-seeking behaviours of adolescents attending the Harriet Shezi Children’s Clinic at Chris Hani Baragwanath Hospital and the Youth-friendly Services at Esselen Street Clinic. The aim is to inform future research in the design and implementation of appropriate interventions for vulnerable youth. An exploratory cross-sectional survey will be conducted, utilising mixed methods, in the two clinics to describe the current cohorts using these services, and to determine factors associated with poor mental health and risk-taking.

Community engagement research WRHI is committed to engaging with local communities and populations around the development and implementation of biomedical prevention research. Most notably, WRHI utilises a range of community and stakeholder advisory mechanisms, including participatory research (e.g. community mapping), community radio, community events, mobile phone technology and Community Advisory Boards (CAB). The UNAIDS/AVAC Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials 2010 (GPP) guides the WRHI’s work. Through a partnership with AVAC, a U.S.-based advocacy organisation, the WRHI aims to ensure that all research projects are GPP-compliant.

Community Radio Tshireletso Health Talk Tshireletso Health Talk is a weekly radio show broadcast on community radio. It uses a talk show format to raise important reproductive and sexual health issues and generate awareness of clinical trials. The broad aims are to engage the community with the WRHI through the promotion of scientific literacy. It is anticipated that local community members become knowledgeable health consumers and informed participants

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Research Programmes

which economic interventions and their conditions can be delivered and managed in urban settings, as well as the feasibility and acceptability of the pilot intervention in this setting, especially with respect to unintended or negative consequences of the programme. The study is funded by the USAID Research to Prevention Programme and will be led by Dr Sinead Delany-Moretlwe and Dr Catherine MacPhail at WRHI. Results are expected in 2013.

30 in clinical trials. The radio show benefits communities within the footprint of the radio station (Alex FM). Key collaborators are Alex FM and ABC Ulwazi. In 2011, a paper was presented to the South African AIDS Conference, entitled ‘I heard about the study on the radio’: using community radio as a mechanism for improved good participatory practice in clinical trials’. This study is funded by the Wellcome Trust as part of its programme of funding on public engagement in science.

Community Advisory Boards (CAB) The WRHI has worked with Community Advisory Boards (CABs) for clinical trial research since 2002. A CAB is a representative group of stakeholders that meets to discuss issues of common concern or interest around a research agenda. The establishment of a CAB serves to enhance transparency and communication to bridge the gap between the researchers and the community where research is being conducted. Currently, WRHI has three CABs that serve Hillbrow-based adult research studies; Hillbrow-based youth research studies; and Soweto-based (Harriet Shezi)

paediatric research studies. The CAB role is to provide feedback on certain aspects of project development and community issues. It is advisory in nature and advises on language and readability of study materials, management of community hearsay and rumours, recruitment and retention strategies and challenges, and trial results dissemination. The CAB composition is different for each CAB and typically includes 12-15 members. The Hillbrow adult CAB includes men and women of different ages who represent all the areas served by WRHI services. The Hillbrow youth CAB includes youth aged 15-21 who also represent areas served by WRHI. The Soweto-based CAB includes parents of the paediatric patients who receive care at the Harriet Shezi clinic. Over the last year, a comprehensive review and evaluation of CAB activities was completed and each CAB has been reinvigorated with new terms of reference, membership and a research literacy training curriculum. A manuscript on the CAB activities since 2002 is in draft form and an abstract on the role of GPP in one microbicide study (FACTS) has been submitted for the Microbicides 2012 Conference.

Research operations department Overview of the WRHI Research Operations Department

team for all studies run at the WRHI Hillbrow and Yeoville research sites and a team managing FACTS Core.

The Research Operations Department was formed in 2010 to provide strategic support in the areas of community outreach, regulatory compliance, pharmacy, laboratory and data management. The teams under these five areas currently support the successful implementation and smooth running of clinical trials or studies undertaken by the Research Programmes.

Research Operations team (WRHI Hillbrow and Yeoville research sites)

The goal of the Research Operations Department is to standardise and support research operations activities across different studies and sites within the Institute. Previously, there was unnecessary duplication, with studies independently creating parallel systems such as recruitment plans, laboratory testing processes and so on. The aim is to streamline processes, and use past and present experience to prevent effort replication.

Research Programmes

Research Operations has developed systems to: ›› reduce the ‘project-specific’ mentality and increase understanding of Institute-wide functions ›› provide staff back-up and support across projects ›› utilise generic standard operating procedures and processes ›› centralise specialised procurement to be more cost-effective There are currently two parts of Research Operations – a

This team currently provides support for the following studies: MTN003 MTN015 MTN016 FACTS001 (at Yeoville) HARP (HPV in Africa Research Partnership) Biomarkers Afrevacc CHAVI The team is managed by a research operations manager and includes: ›› A community outreach team consisting of 20 people, headed by an outreach manager. The team includes community health workers who are responsible for recruitment and retention of project participants, as well as community liaison officers, who ensure good working relationships with members of the community, stakeholders, clinics, DoH and COJ staff, and the community advisory boards.

Wits Reproductive Health & HIV Institute

31 Research Operations team (FACTS Core) FACTS Core is the WRHI co-ordinator of a set of FACTS trials being run at nine sites in South Africa, as explained above. The nine FACTS sites are: WRHI – Yeoville Aurum – Rustenburg Aurum – Tembisa PHRU – Soweto Desmond Tutu HIV Foundation – Cape Town MATCH – Pietermaritzburg QM – Ladysmith Medunsa – Garankuwa Setchaba – Shoshanguve The FACTS Core team research operations manager works closely with all the laboratory managers at the FACTS sites, CLS, as well as the clinical research associates at the African Clinical Research Organisation (ACRO), which is the monitoring arm for the study, to ensure smooth site activation and trial outputs. Future plans for the research operations department include: ›› Expansion of services to the greater WRHI ›› New laboratory including a specimen repository within the Hillbrow Health Precinct ›› Technical support to our partners

Research Programmes

›› A regulatory team comprising two staff members who handle communication with the ethics committees and Medicines Control Council (MCC). This team oversees the myriad of documents required for ethical approval of clinical trials, including informed consent forms, flyers and brochures, posters, protocols, and letters of amendment. Studies also require regular reports and annual recertification. In addition, the regulatory team performs in-house monitoring and quality assurance to ensure quality data, and interacts with external monitors and auditors sent by project sponsors. ›› A pharmacy team with staff based at the Hillbrow and Yeoville research sites. The team consists of two pharmacists and three pharmacist assistants. The pharmacies dispense study medication for those clinical trials where an investigational product is involved. For other studies, concomitant medications are dispensed such as treatments for STIs, contraceptives, hepatitis B vaccines, and other miscellaneous medicines for non-chronic diseases. ›› A laboratory team consisting of seven staff members, comprising medical scientists and medical technologists under a laboratory manager. The laboratory at Hillbrow was built in 2010 and the laboratory at Yeoville was completed in August 2011. The laboratory offers onsite testing including HIV rapid tests, pregnancy tests, urine analysis, Gram staining, and sample storage. Testing is accredited through the College of American Pathologists. Some laboratory testing is outsourced to external suppliers such as Contract Laboratory Services (CLS), National Health Laboratory Services (NHLS) or Bio Analytical Research Corporation (BARC). ›› A data management team consisting of 15 staff members including three data managers, a database programmer/developer, data capturers and data quality improvement managers. This team is responsible for either capturing study data onto databases by single or double entry systems, or sending case report forms (CRFs) by DataFax to study Data Centres.

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Community Programmes It is widely accepted that community systems and health systems are complementary and synergistic in their local environments. Access to and uptake of health services is influenced by social and psychosocial factors such as: income and social status; education; physical environment; employment and working conditions; social support networks; coping skills; and gender. Engagement with key community actors can have a positive influence on the community’s interface with the health care system and can impact on health outcomes. Community Programmes at WRHI aims to facilitate the interface between community structures, formal and informal, and sexual and reproductive health, with a focus on HIV services. In so doing, critical information is gained about community needs and attitudes, which can then be translated into relevant interventions that resonate with the local population. Our close connections with the community give us unique access to key populations, including sex workers and men who have sex with men (MSM). Research has shown that individuals in these vulnerable groups often engage in behaviours that are criminalised and/or stigmatised, creating barriers to accessing HIV prevention, care and treatment services. Through direct engagement with marginalised populations, Community Programmes is able to research and implement appropriate interventions

adapted for different sub-groups especially vulnerable to HIV. Community Programmes provides a package of services which includes risk reduction tools; counselling; condom distribution; skills-building; HIV and STI screening and treatment; nutritional advice and lifestyle management; and psychosocial support. A team of peer educators assists with service delivery, providing counselling, education, buddy support and referral. The personal nature of peer-to-peer communication means that we have more authentic and detailed feedback about the issues and challenges facing our community than we could gain through clinical contact alone. This feedback informs prospective research initiatives as well as programmatic interventions. Community Programmes consists of a number of projects:

Youth-friendly Services Project

Community Programmes

The Youth-friendly Services Project aims to improve the sexual and reproductive health of youth, through facility-based clinic services and outreach programmes including health education. This is achieved by: ›› Providing a model of youth-friendly services at Esselen Clinic in Hillbrow ›› Increasing the uptake of HIV-related services, particularly among young people in the Hillbrow community ›› Providing quality clinical care and health education and outreach to youth in the community ›› Extending the youth-friendly concept into other PHC clinics Youth peer educators take sex education and life skills training into schools, shelters and other places where young people gather, such as parks and playing fields. Because of our combination of clinical and outreach services, our peer educators are uniquely placed to refer clients into the youthfriendly clinic, thus ensuring the benefits of peer education can be realised and measured. We also host school holiday programmes which combine fun activities with situational learning about reproductive health and gender issues.

Highlights from the past year include: ›› Incidence (new HIV infection rate) decreased from 7.3% to 6.4% among youth seen in the clinic ›› Pregnancy rate among young women attending the youthfriendly clinic has decreased

Wits Reproductive Health & HIV Institute

peer educator in the youth-friendly clinic

33 from 57% (October 2009-September 2010) to 37% (October 2010 -September 2011) ››A wellness programme for HIV-positive youth was established in February 2011 and ART initiation commenced

September 2011 ›› A new partnership with Johannesburg Correctional Services was established which resulted in counselling and support group facilitation at Johannesburg Prison ›› In partnership with University of Johannesburg students from different schools around Hillbrow were taught to be peer educators in their respective schools. 30 school-going youth graduated from the programme and began educating peers in their schools

Women at Risk (Sex Worker Project) The objective of the Sex Worker Project is to reduce the rate of sexually transmitted infections (STIs) and HIV transmission by providing STI treatment services which are accessible and acceptable SWP project nurse to sex workers, and to increase access to STI/HIV prevention. In addition, the project works to improve access to care and treatment for this marginalised and difficult-to-reach group. The Sex Worker Project provides outreach support services to 22 brothels in the inner city of Johannesburg under the supervision of a nurse; and a mobile clinic provides services to street-based sex workers in sex work ‘hotspots’ once a week. These services include assessment, diagnosis and appropriate treatment for sex workers and their clients with regard to sexual and reproductive health. Sex workers are encouraged to access HIV Counselling and Testing (HCT) services which are provided free of charge, along with CD4 screening and referrals for ART and management,

health education and workshops related to behavioural and lifestyle changes. The project provides referral into other appropriate clinical and non-clinical services, and works with service providers in local clinics to sensitise them to the needs of this group. The project provides support to the development of other strategies to increase the safety of sex work, including advocacy efforts. The project also supports male sex workers. Highlights from the past year include: ›› ART initiation is now undertaken within the project (39 females and two males in the reporting period), avoiding referral to the general initiation site and the subsequent loss-to-follow-up that used to occur ›› Skills development and assistance with job-seeking is provided to sex workers who would like to exit the industry ›› The launch of a study to improve identification of acute HIV in female sex workers and to determine the acceptability of pre-exposure prophylaxis (PrEP) as an HIV prevention strategy and to determine HIV clades among sex workers (see ‘Research Programmes’)

The Men & HIV Project aims to strengthen male utilisation of sexual health and HIV services at Esselen Clinic and Region F clinics and to identify and initiate other services which are relevant for men’s participation, for example promotion of comprehensive HIV prevention strategies (male circumcision, condom use and dissemination of key messages such as reduction in the number of partners). Some of the tools used to achieve this include: targeted HIV testing campaigns in areas like taxi ranks, hostels, taverns, busy streets, police stations; a weekly men’s club that provides a safe environment for discussion of sexual health issues, e.g. inter-generational sex, circumcision, gender-based violence. There has been a special initiative to provide HIV testing and outreach work for men who have sex with men (MSM). Other activities include engagement

every day’s a busy day in the youth-friendly clinic

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Men & HIV Project

34 with men and boys through sporting events and special celebrations; support groups; workshops on HIV and men’s health; and condom and information and behaviour change communication materials development and distribution. Highlights from the past year include: ›› A support group for male sex workers has been established, led by two MSM sex workers who have provided tremendous insight into work with this population. Currently over 15 participants regularly attend ›› The project contributes to a standing monthly slot on Alex FM to discuss men’s issues during drive time in the afternoon

clients fill in paper work prior to visiting the mobile clinic

Mobile Clinical Outreach Service The Mobile Clinic Service offers free comprehensive sexual and reproductive health services, TB screening and treatment for minor ailments to marginalised groups, including refugees and migrants, who have difficulty accessing conventional health care services, in the Johannesburg inner city and beyond. The mobile clinic also supports the Gauteng

Department of Health and the City of Johannesburg and other stakeholders with the provision of HIV Counselling and Testing. In addition, the service assists in the strengthening of referral systems within the communities it serves. Highlights from the past year include: ›› Active collaboration and partnership with other community organisations, churches, and the business community which has led to the increased demand for the Mobile Clinic Service to provide comprehensive services ›› The Mobile Clinic Service now provides outreach services to three of the biggest Cash and Carry Stores in Johannesburg with a total of more than 1,000 employees

Community Programmes

Community Care Centre The Community Care Centre is a free walk-in service centre that caters for HIV-positive people and their families and the broader community giving general support, counselling, wellness support, information, advice and referral. The Centre is a partnership involving a large number of NGOs and CBOs who work together to provide a broad range of services. In addition, emphasis is placed on developing a creative partnership environment with the aim of enabling emerging needs to be identified and addressed with innovative solutions. The Community Care Centre provides psychosocial support and care to people living with HIV who do not yet qualify for ARV treatment, as well as to people who are on ART and require adherence and other wellness support. The centre provides information, skills training and support on a range of health, HIV prevention, social and economic issues broadly to a needy and deprived inner city community. Highlights from the past year include:

a client contemplates a visit to the mobile cliniC

›› Free HIV/AIDS legal clinic launched in partnership with Pro Bono, legal resources NGO ›› Over 240 community members attended educational

Wits Reproductive Health & HIV Institute

35 workshops on topics as varied as reproductive cancers (with a screening facility provided); ‘recognising substance abuse in your child’; ‘grieving, bereavement & mourning’; and respiratory health (with TB screening) ›› English literacy classes assisted community members to improve their written English to

in turn improve their job-seeking skills ›› Over 7000 people accessed the internet at the Cyber Café, facilitating access to information on health and rights issues and assisting in job search. More than 300 people received IT skills training

Fit for Life, Fit for Work Fit for Life, Fit for Work is a youth training scheme that combines life coping skills with work preparedness to provide industry with an eager and enthusiastic work force well versed in the practical and ethical requirements of the work place. At the same time, the course gives young people the self-confidence and self-esteem to make life-enhancing rather than destructive decisions in their personal lives. Fit for Life, Fit for Work aims to tackle the interrelated challenges of socioeconomic disadvantage and HIV risk in youth (age 18-30) by teaching the skills needed to secure employment and reduce risktaking behaviour, as well as heightening sensitivity to gender and reproductive rights issues, with the long-term aim of impacting positively on HIV incidence in this age group.

evidenced via baseline and follow-up surveys, giving results such as: 79% of participants reported condom use in the past month at follow-up compared to only 61% at baseline

Highlights from the past year include: ›› 183 youth (60% female) completed the course, with 135 (74%) securing employment, learnerships or entry to tertiary education ›› Positive changes in Knowledge, Attitudes and Practice are

a Fit for Life learner practises role-play with the trainer

Paediatric, Adolescent & Caregiver Support drama programmes, and a model of peer education and peer counselling, the Paediatric Project seeks to improve adherence to medication and ensure HIV-positive teenagers are able to focus on life and their hopes for the future. Highlights from the past year include: ›› 18 adolescents from Hillbrow Community Health Centre, Natalspruit Hospital and Charlotte Maxeke Johannesburg Academic Hospital support groups were trained as peer counsellors ›› In collaboration with Wits University third year medical students, 14 caregivers were taught how to plan and prepare an affordable well-balanced diet

HIV-positive adolescents learn goal-setting

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Community Programmes

Unlike Youth-friendly Services, which targets youth generally and has a strong focus on prevention and access to services, the Paediatric Project exists to improve the psychosocial health of children, adolescents and their caregivers who are infected and affected with HIV, often perinatally. Through a programme of support groups, holiday programmes and camps, caregiver support groups, sexual and reproductive health workshops,

Hillbrow Health Precinct (HHP) The Hillbrow Health Precinct development seeks to create a visionary, world-first health precinct addressing HIV and related diseases, poverty and urban renewal in Johannesburg’s inner city. It does so by delivering outstanding health services and health care worker training, in addition to developing best practice models and world-class research that is relevant to the African continent. Background The City of Johannesburg, Gauteng Department of Health and Social Development and the WRHI signed a Memorandum of Understanding (MOU) seven years ago to realise the development of a common vision. This MOU was premised around a concept created to restore the urban decay that has occurred in Hillbrow and which includes the restoration and conversion of several buildings into centres that provide a wide spectrum of health-related services, in which the City of Johannesburg, the Gauteng Province and the WRHI participate.

One of the heritage aspects of the precinct that makes it exceptional is that it provides examples of architecture from the earliest building constructed in 1897 to the last significant structures, built in the 1970s. The value of the buildings lies not only in the historic style of their design but also in what they can teach us about the evolution of health care and related technology in Johannesburg, plus the historical association with countless medical students, doctors and nurses who learned their profession at facilities in the area.

Hillbrow Health Precinct (HHP)

Shandukani Shandukani is a Venda word meaning ‘change’ or ‘asking for change’, and the Shandukani project is a flagship public/private partnership that represents support for community clinics, community health programmes and HIV awareness in a truly integrated manner. The public/private partnership creates a crucial focal point around which further development will take place. The Gauteng Department of Health and Social Development will be the recipients of a world-class maternal, adolescent and child specialised medical and research facility made possible by the generous R28m CSI grant from Vodacom, Altron and Altech companies. The Shandukani project encapsulates

Wits Reproductive Health & HIV Institute

37 the objectives of the Hillbrow Health Precinct which aims to strengthen the delivery of health and social services through the regeneration of disused and deteriorated building stock, thereby increasing the asset value of department properties. As renovations are completed, the facility will become a centre of excellence for maternal, adolescent and child health, for the training of health care providers, community workers and researchers, and will be a focal point for conducting world-class research on a range of health-related topics of national and regional relevance, including HIV; TB; maternal and child health; infectious diseases; reproductive health; and social science. The possibilities created by this public/private partnership in enhancing child, adolescent and maternal health and simultaneously contributing to inner city renewal reflect the commitment and vision of the corporations involved and offers an innovative model for further corporate social

the Shandukani building takes shape

investment and public/private partnership opportunities.

Highlights for 2011

›› An Urban Design Framework for the entire northern portion of the precinct has been generated with the professional assistance of the University of the Witwatersrand Campus Development and Planning Unit with a plan for a fully integrated campus-like precinct ›› Standardised landscape and signage schema have been developed and all new developments conform to these precinct-wide parameters ›› Detailed design work has been undertaken for the western edge of the precinct, with the application for heritage status of the Physics and Mortuary buildings and the expansion of their use ›› The upgrade of the two previously dilapidated and unmanaged sanitary lanes off King George Street made possible via funding from the Johannesburg Development Agency has contributed to the improvement of the environment ›› WRHI has joined a community initiative, the Ekhaya Neighbourhood. The synchronicity between the organisations with respect to community outreach and involvement, combined with HHP’s involvement in security and urban management, brings benefits to all parties ›› Plans for the expansion and refurbishment of the 1st and 2nd floors of Ward 21 have been completed, and will be implemented when funding is secured ›› Hillbrow Health Precinct Committee Meetings have been held regularly and participation by high level representatives of the Gauteng Department of Health and Social Development, the City of Johannesburg and the University of the Witwatersrand has been an important step in taking the process forward

›› The adoption of the Hillbrow Health Precinct logo by the Committee is an important expression of this partnership

ANNUAL REVIEW 2010-2011

Hillbrow Health Precinct is a treasure trove of historical buildings

Hillbrow Health Precinct (HHP)

Highlights for 2011 include:

WRHI Training Department Overview of WRHI’s Training Department Since its inception in 1996, WRHI has been involved in the provision of a broad range of health care provider training. Over the years, targeted training has been developed in response to the changing landscape related to sexual and reproductive health, HIV, quality improvement, and health systems strengthening. This has always been

integrated into separate WRHI programmatic divisions including staff development. After the restructuring in 2010, the Institute launched a separate training department. The vision and objectives are described below. The WRHI Training Department is sub-divided into training quality, external training and internal training.

Training Department – our vision and objectives

WRHI Training Department

WRHI’s Training Department strives to establish a sustainable training entity with a strong reputation for quality training and learning that proactively supports the overarching strategy of the Institute.

nurse & counsellor training

To this end we will: ›› Fully utilise the Institute’s skills & experiences ›› Niche courses e.g. DipSHIV, Advanced HIV Management, Clinical Trials ›› Maximise good practice and innovations e.g. hot topic symposiums and ‘how to…’ seminars ›› Ensure internal benefit and responsiveness ›› Accurate learning needs data with synergised training and development plans for all staff ›› Pilot externally planned courses internally first ›› Maximise visiting students for organisational gain e.g. contribution to CPD programme, mining data for publications ›› Work smarter for organisational sustainability ›› Maximise successful training ‘products’ and offer to new target learners e.g. Khulani for DoH, HIV and QI courses to private health sector ›› Increase partnerships and collaboration with private sector, Wits and other academic institutes ›› Apply training strategically ›› Influence pre-service training e.g. HIV programme for nurse tutors ›› Link conference attendance to CPD programme ›› Improve organisational reputation ›› Accreditation: SAQA, Council of Higher Education, HPCSA, Wits ›› Host senior students both international and local ›› Support internal studies: increase Master’s and PhD outputs

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39 External training WRHI has an active training portfolio and in the last year trained almost 1 200 health care workers. The main focus has been on supporting the NDoH’s strategy to strengthen health systems, increase access to ART and increase HIV counselling and testing (HCT), including provider-initiated counselling and testing (PICT). The capacity-building processes have focused on small groups of health care workers with mentoring and followup to ensure effective learning and to increase the probability of real, sustained transfer of learning in the workplace.

Counselling training:

NIMART (Nurse initiation and management of antiretroviral treatment): In assisting with increasing access to ARVs, more than 350 professional nurses have been trained and mentored in initiation and management of both adult and paediatric HIV patients. To further sustain the NIMART programme, WRHI, in collaboration with DoH district partners, identified almost 50 nurses as potential NIMART mentors, who were then clinically assessed via a rigorous OSCE process (Objective Structured Clinical Examination) and further trained and supported by WRHI.

Targeted health care provider training – HIV and TB: Over 300 nurses and other health care workers have been capacitated in PICT. For example: in Ekurhuleni an orientation module for facility managers was piloted to reinforce the purpose of PICT and their role in ensuring the programme is effectively implemented. In addition, over 200 other staff categories have participated in a wide range of targeted training such as adherence, TB counseling, and monitoring and evaluation. The Institute has also been instrumental in improving the access and quality of paediatric HIV care at hospital level with a concentrated learning programme for all related health care workers in a Gauteng district hospital.

WRHI training manuals

In recognition of the damaging psychological impact of trauma and bereavement, WRHI’s experienced Counselling and Other Prevention Team provided training to over 250 nurses, counsellors, social workers and members of the South African Police Force and produced a capacity-building CD on trauma counselling. The Training Department has also worked in close collaboration with the Institute’s clinical trial community liaison teams and provide capacity-building in basic HIV, sexual and reproductive health and TB for 30 community advisory board members.

Clinical HIV Management Course: WRHI has a solid background of providing critical capacity-building on a regional level in both HIV management and research skills. Now in its tenth year, the Clinical HIV Management course aims to build on existing regional HIV treatment knowledge and expertise, by developing clinicians’ abilities to effectively manage adult and paediatric HIV complications and provide leadership in HIV prevention, treatment and care. Twelve countries in the region were represented by 142 clinicians in the last year who gave positive feedback on their learning experience. “It has been a very informative training and has changed how I will treat HIV-infected patients, especially children.” Rural-based participant, March 2011.

Participatory learning on the Clinical HIV Management course

The Research Methods Course has been held annually since 1997 and was developed by WRHI and collaborating organisations, the Medical Research Council and the Population Council, as an African response to the need for research capacity-building in the African region. The course seeks to introduce African researchers, health service managers and clinicians to the fundamentals of research methodology and key sexual and reproductive health and HIV issues relevant to their regions. Alumni reported one publication in an international, peerreviewed journal and two posters presented at regional and international conferences in the last year. One of the comments from the alumni evaluation form completed for 2010/2011 was:

ANNUAL REVIEW 2010-2011

WRHI Training Department

Research Methods Course:

40 “The experience and knowledge I gained on the course assisted me in successfully applying for a position directly involved in SRH research instead of doing it as an aside to my work.” The 18 participants from seven African countries who engaged with the course in 2011 brought the total alumni to 377 who are encouraged to develop communities of practice.

Sexual and reproductive health: In line with its rich background in sexual and reproductive health, WRHI this year facilitated the development of a training curriculum for professional nurses in Contraception and Fertility Planning on behalf of the National Department of Health to support the implementation of the revised contraception policy guidelines. In addition, a pilot learning programme to support clinicians working towards the Higher Diploma in Sexual Health and HIV was also launched.

WRHI, in keeping with its polydisciplinary character, teaches across the University departments from the Faculty of Health Sciences to the Business School. Most teaching occurs within the Department of Internal Medicine at Charlotte Maxeke Johannesburg Academic Hospital, to internal medicine and microbiology registrars and trainee sub-specialists in infectious diseases, where bedside teaching, ward rounds and occasional didactic lectures support the Department’s training efforts. In addition, the Institute continues to support the GEMP and undergraduate clinical programmes through bedside and didactic teaching in the fields of HIV and infectious diseases. Support is also given to courses supporting registrars to complete their Master’s degree.

Internal training Embedded in the Institute’s mission is a ‘commitment to our staff and creation of a sustainable institute’. To this end, the organisation has adopted a robust skills development strategy including a rigorous learning needs analysis resulting in training and development plans per team, the progress of which is monitored, culminating in evaluations of the effectiveness of planned learning interventions. In the past year, staff members have been further developed in clinical and research skills, and supporting skills such as presenting with confidence, reportwriting and performance management.

Continuing professional development: There has been a significant shift away from traditional formal courses as a capacity-building solution and more creative approaches have been piloted this year, particularly for continuous professional development, such as e-based learning modules and email case discussions. Not only does this search for more diverse, appropriate learning solutions address issues of equity and access with such a widely geographically spread staff complement, it also ensures that funds available for staff development are maximised.

WRHI Training Department

Khulani – WRHI’s management and leadership programme: Khulani is an internal leadership course which was initiated by the Institute in 2009, and takes managers through the life cycle of an employee from recruitment to dealing with diversity and career development, and empowers team leaders to effectively manage for maximum performance. Since its inception, 114 managers have been trained, 45 of whom were trained in 2011.

Staff learn effective business writing

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Strategy and Development Department (SDD) Introduction The Strategy and Development Department was established as part of the new Institute structure in response to the need for an integrated organisational approach to sustainability, communications and development, in the context of the increasing complexity of WRHI’s requirements.

Development and Strategy & Communications. Together they drive a package of organisational change, including strategic planning vehicles such as the Leadership Development Forum and the implementation of tools such as the Enterprise Resource Planning system and intranet.

The SDD comprises two interrelated disciplines: Grants &

Grants & Development The Grants & Development function within the SDD provides a comprehensive view of WRHI’s financial situation and enables the Institute to monitor the budget and expenditure and assist with planning for future sustainability. Current annual expenditure is R300 million, representing 300% growth over five years. Grants & Development has introduced a standardised Institutewide budgeting process that ensures a coherent and consistent

approach to financial planning and not only enhances our prudential management but ensures we are able to respond effectively to new grant opportunities. “Having a more solid foundation for our finances means that we can better attract new funding. Our reputation for technical excellence is underpinned by robust financial support systems,” says Daphne van der Wind, Head of Grants & Development.

The Strategy & Communications function within the SDD ensures that all communication, both internal and external, is focused, effective and aligned with the Institute’s strategic objectives. The aim of Strategy & Communications is to leverage communication opportunities to support the strategic focus of WRHI and project a congruous organisational personality to all our stakeholders, regardless of the nature of their engagement with the Institute.

organisation-wide sharing of information, it allows technical co-operation through shared work spaces. The compilation of a regular staff newsletter has also contributed to a growing sense of fraternity and has improved intra-organisation recognition of and support for colleagues and their work.

The past year has seen the focus rest firmly on internal communications, as two related but very different organisations were brought together to form the new Institute. It has been critical for staff morale and cohesion to ensure the emergence of a well-defined identity for WRHI, with a distinct personality. WRHI has begun to formulate strategies to accentuate the mission, vision and values of the Institute, and to ensure that these are understood and supported by all our staff. WRHI is a large, complex organisation, and the role of internal communications is to facilitate communication between programmes and departments to encourage collaboration and ensure operational functionality. To this end, we have developed an intranet, which not only provides a platform for

ANNUAL REVIEW 2010-2011

Strategy and Development Department (SDD)

Strategy & Communications

42 Also occupying the Strategy & Communications team last year was the rebranding of WRHI. Involving more than just a name and logo change, becoming an Institute meant a re-evaluation of our core values; and we needed to create a corporate identity representative of our position as an internationally acclaimed agent of innovation and social change. This was not an easy task, and while the hard intellectual work is done, we still have a long road ahead of us in terms of completing the rebranding exercise on a practical level. A highlight of the year in the South African context

Putting the finishing touches on an important funding proposal

Strategy and Development Department (SDD)

was the role WRHI played in the SA AIDS Conference in Durban in June. WRHI Deputy Executive Director, Francois Venter, was Chairperson of the fifth SA AIDS Conference. WRHIâ&#x20AC;&#x2122;s research and programmes were proudly represented by an unprecedented number of oral and poster presentations. WRHI Communications ensured our staff were well supported and the Institute enjoyed pride of place in the exhibition hall. Whilst the first year has focussed on internal organisational strategy and communications issues, 2012 will focus on external stakeholders and their information requirements. We want to draw our partners closer to us and take a leading role in supporting the communications of the various research consortia of which WRHI is a part. As we look into the future, a priority will be supporting our technical and advocacy platforms with clear and effective communication strategies. Technical expertise rests in the programmes; the role of Strategy & Communications is to facilitate the communications function across the organisation and to capacitate programme staff to promote and publicise their successes. We anticipate a busy year ahead!

Wits Reproductive Health & HIV Institute

Operations Department The Operations Department was established in October 2010 to restructure the operational systems required to support the newly formed WRHI. This involved the merging, rationalisation and realignment of the two RHRU Clusters, (Research and HIV Management), the national and executive offices, as well as ECHO, and the development of concomitant systems to mirror the newly formed institute. The Operations Department had the mammoth task of consolidating all operational functionality across a complex array of systems, processes and resources, including business units, facilities, policies, standard operating procedures and assets.

The Department has three key portfolios: (i) The Shared Services portfolio which includes financial transactions, travel, procurement, asset management, and compliance. (ii) The Facilities & Safety portfolio, responsible for the management of facilities, fleet, Occupational Health and Safety, and meetings and events. (iii) The Information Systems portfolio which oversees the information systems strategy, operations management and infrastructure.

Marinda Bouwer, General Manager, Operations

co-ordinators, administrators and personal assistants across programmes and departments to ensure operational efficiency. An ongoing process of internal capacity-building has been instituted, with bimonthly trainings to ensure that knowledge of operational policies and SOPs is at optimal level.

Interventions during 2011 focussed on the development of new policies and systems to meet the needs and support the growth This Operations Department has 60 staff members led by of the Institute. Specifically, the implementation of cost-effective the General Manager: Operations, together with the three technologies was prioritised. To this end, a new in-house IT portfolio managers, who liaise with approximately 19 operations department was established. One of its first tasks was the upgrading of our IT infrastructure, securing robust scaleability to accommodate future growth in conjunction with ISP and MPLS (Internet Service Provider and Multiprotocol Label Switching) capacity planning and management. In addition, Hugh Solomon Building underwent a comprehensive space audit in 2011, resulting in substantial refurbishment to accommodate the increased staff numbers and demand for space. This involved a complicated process of moving staff, with minimal disruption. Operations Leadership Group in session

ANNUAL REVIEW 2010-2011

Operations Department

The Operations Department aims to ensure that there is a solid operational infrastructure and seamless operational efficiency to service the needs of the Institute’s five departments, five programmes, 14 sites and nearly 600 staff members.

Epidemiology and Biostatistics Department Overview of the Epidemiology and Biostatistics Department The epidemiology and biostatistics team was formalised into a department in late 2010. The team has expanded since its inception to better support WRHI’s growing research portfolio, and comprises a clinical epidemiologist, two epidemiologists and a biostatistician. The Epidemiology and Biostatistics Department‘s key functions are to:

›› Assist with the conceptualisation, design and refinement of studies to answer clinical and operational research questions ›› Analyse data and prepare publications ›› Provide studies and projects with data management support ›› Develop the capacity of researchers within WRHI to design elegant studies and analyse data

Study conceptualisation and design During 2011, members of the Epidemiology and Biostatistics Department assisted with the design and review of 11 research protocols including two cluster randomised trials, two randomised controlled trials, three diagnostic studies, one pharmacokinetic study, a cross-sectional survey, two cohort studies and a qualitative study. The studies reflected the broad scope of WRHI’s research agenda, including studies to determine

an appropriate dose of rifabutin for HIV-TB co-infected children, evaluate new HIV and TB diagnostic tests, assess the safety and efficacy of different ART regimens in adults, optimise the implementation of HPV vaccination programmes, assess the role of male partner involvement in the PMTCT programme and explore risk behaviours of HIV-positive and negative adolescents. Three of these protocols entered the field during 2011.

Epidemiology and Biostatistics Department

Data analysis and publications WRHI generates a huge wealth of data from its numerous studies and projects. The Epidemiology and Biostatistics team is directly responsible for analysing some of these data. During 2011 members of the team co-authored nine papers, with a further two having been submitted for review. The team also co-authored six conference presentations.

A key focus in 2011 was the preparation of data for secondary analyses of WRHI’s site data from the Microbicides Development Programme PRO 2000/5 microbicide gel study. Preparatory work has been completed and it is anticipated that six papers will be published from this important dataset in 2012.

Data management support The Epidemiology and Biostatistics Department provided data management support to a number of studies and projects during 2011. A participant tracking database to support the scheduling and retention of research participants is in the process of being developed. It is anticipated that the tracking database will provide an organisational-wide platform for supporting the scheduling and tracking of clinical trial participants. During 2011, the team also explored and implemented Open Data Kit (University of Washington), a novel open source data collection tool run on mobile phones, to collect information from adolescents on risk behaviours. The system holds Biomarker samples ready for analysis

Wits Reproductive Health & HIV Institute

45 great promise to improve both the efficiency and reliability of self-reported data through increasing anonymity and decreasing bias arising from social desirability. The system is being considered for use in two studies to launch in 2012.

Capacity-building The Epidemiology and Biostatistics Department conducted an intensive seminar on the theory and application of interrupted time series analysis and ARIMA models to evaluate programmes. The team runs a Stata (R) Users Group which meets regularly to develop the analytical skills of WRHI staff members. During 2011 team members successfully supervised two Masterâ&#x20AC;&#x2122;s students, with a further three Masterâ&#x20AC;&#x2122;s studentsâ&#x20AC;&#x2122; projects in progress.

Capturing biostatistical information

ANNUAL REVIEW 2010-2011

Epidemiology and Biostatistics Department

Accurate patient records are essential for epidemiological study

WRHI Leadership

Strategic Leadership Group

Professor Helen Rees, Executive Director Professor Rees is the founder and Executive Director of WHRI and Personal Professor in the Department of Obstetrics and Gynaecology. She is an Honorary Professor in the Department of Infectious and Tropical Diseases of the Clinical Research Unit at the London School of Hygiene and Tropical Medicine. Professor Rees received her Medical Degree and a Master’s in Social and Political Sciences from Cambridge University and in 2002 became an alumnus of Harvard Business School. Professor Rees is one of South Africa’s most wellknown women scientists. She worked as an activist in the

health sector throughout the 1980s and helped the African National Congress develop the Health Policy for a post-apartheid government. Professor Rees has continued to work with government on many aspects of health policy. Her research interests include HIV/AIDS prevention, PreP and microbicides, HIV and HPV vaccines, and broader issues relating to women’s health. She is the Protocol Chair of the multicentred South African FACTS study. She is the Co-Chair of South Africa’s National AIDS Council’s Programme Implementing Committee and a member of the South African National AIDS Trust. She is a member of the National Advisory Group on

Immunisations and chairs the Expert Committee advising on contraceptive policy. Previously, she served as the Chair of South Africa’s Medicines Control Council and was a member of the National Research Ethics Committee. Professor Rees is the Chair of the WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) and serves on the board and Policy Committee of the Global Alliance on Vaccines and Immunisation (GAVI). She serves on many international boards and committees, including the board of the International AIDS Vaccine Initiative (IAVI), the board of AVAC

Wits Reproductive Health & HIV Institute

and the Scientific Advisory Committee of the Centre for HIV & AIDS Immunology, the Advisory Committee to NIH’s HIV Prevention Trial Network and to the Population Council’s microbicide research group. She serves on many WHO committees advising on PreP, treatment as prevention and contraception.

47 Professor Francois Venter, Deputy Executive Director Professor Francois Venter is WRHIâ&#x20AC;&#x2122;s Deputy Executive Director and lecturer in the Department of Medicine, University of the Witwatersrand. He is the Head of Infectious Diseases at the Charlotte Maxeke Johannesburg Academic Hospital. Professor Venter is a past President and serves on the board of the Southern African HIV Clinicians Society, which has over 12 000 members in the region.

in these areas and an interest in monitoring and evaluation of clinical interventions, as well as a human rights interest in access to quality care. He has published several operational research studies. He has been part of and continues to participate in several important South African and regional policy-making fora. Professor Venter was the Chairperson of the 5th SA Aids Conference in 2011.

Professor Venter has expertise in programmatic HIV implementation, especially provision of antiretroviral therapy, opportunistic infection prophylaxis, human resource allocation, data systems and service integration. He has extensive training experience

Dr Eugene Sickle, Deputy Executive Director: Strategy and Development Dr. Eugene Sickle has a doctoral degree in Synthetic Organic Chemistry from the University of Cape Town and considerable post-doctoral experience in the area of Medicinal Chemistry. After several years in academia he moved to the WRHI to lead the Instituteâ&#x20AC;&#x2122;s USAID-PEPFAR programme and to head the Strategy & Development Department. He currently holds the position of

Deputy Executive Director. Dr Sickle is an expert in strategic financial and programme management.

Dr Delany-Moretlwe has an active interest in the prevention and control of sexually transmitted infections (STIs), including HIV. She led the development and evaluation of brothelbased STI treatment services for sex workers in the residential hotels of downtown Johannesburg, an evaluation of truck-stop clinics for long-distance truck drivers, and the development of quality life clubs for economic migrants to Johannesburg living in single sex hostels and informal settlements. She has also been an investigator on several international multi-centre trials evaluating new technologies for HIV prevention, including genital herpes treatment and novel microbicides. She is currently an investigator on the FACTS 001 multicentred South African trial of tenofovir 1% gel. She is also involved in research on the prevention of human

papilloma virus (HPV) in high HIV prevalence settings. New focus areas include understanding structural factors which increase HIV risk in adolescents. Dr Delany-Moretlwe is an active post-graduate lecturer, supervisor and examiner in sexual and reproductive health and epidemiology. She has served on national advisory committees and as a technical adviser for WHO. Dr Delany-Moretlwe has received several awards including the Best Emerging Woman Scientist from the South African Department of Science and Technology (2006), and a South African National Research Foundation Thuthuka Award (2006).

Ms Mamotho Khotseng, Director: Provincial Health Programmes

Dr Sinead Delany-Moretlwe, Director: Research Dr Sinead Delany-Moretlwe is Director of Research at WRHI. She trained as a medical doctor at the University of the

from the London School of Hygiene and Tropical Medicine (LSHTM).

Witwatersrand in South Africa, and obtained both an MSc in International Health and Tropical Medicine and a PhD in Clinical Epidemiology

Ms Mamotho Khotseng is responsible for the development of strategy for Provincial Health Programmes, based on WRHI strategy and National Department of Health programme priorities. Her remit is to ensure that the provincial programmes are managed within the context of the provincial Memoranda of Understanding. She is also responsible for managing

ANNUAL REVIEW 2010-2011

stakeholder relationships, in particular government and donor relations, participating in key stakeholder meetings at national, provincial and district level. Within the WRHI her portfolio includes strengthening relationships between provincial programmes and other WRHI programmes and departments. Ms Khotseng started her

48 career in nursing, teaching and lecturing, later joining the NGO sector as Director for Planned Parenthood Association of South Africa. From there she became Deputy Director for the NAFCI programme supporting the Western Cape, Eastern Cape, Northern Cape and the Free State. In 2006 she became Director of loveLife in the Free State, before joining RHRU in 2009, where she worked as Quality Improvement

Technical Adviser in the North West. She became WRHI Provincial Head for Gauteng and Mpumalanga in 2010, and was appointed Director, Provincial Health Programmes in 2011.

Dr Thesla Palanee, Director: Clinical Trials As the Director of Clinical Trials Dr Thesla Palanee provides strategic and technical leadership and support in the planning, implementation and management of clinical research within the WRHI. She participates in the development and planning of new research protocols, writing funding proposals for new research and providing guidance on the requirements of local and international regulatory bodies and frameworks. Dr Palanee holds a BSc Honours degree from the University of Natal and has obtained a Master’s in Medical Science degree cum laude from the University of Natal Medical School, as well as a PhD in Biochemistry from the University of KwaZulu-Natal, Nelson R Mandela School of Medicine. She obtained post-doctoral experience in the Department of Molecular Virology and

Bioinformatics at the Africa Centre for Health and Population Studies based at the University of KwaZulu Natal. She also worked at the HIV Prevention Research Unit of the Medical Research Council in Durban as a Scientist and a Specialist Scientist before joining WRHI in May 2009 as Technical Adviser, Clinical Research Management. She then became the Technical Head of Network Trials, Research Centre Programmes until her appointment as the Director of Clinical Trials in 2011.

Dr Vivian Black, Director: Clinical Programmes Dr Vivian Black, Director of Clinical Programmes, is responsible for leading the clinical technical teams in providing technical support to the organisation and to the Department of Health and Social Development. Dr Black joined WRHI in March 2003 and worked in HIV prevention. She has been involved in initiating an integrated antenatal antiretroviral clinic at Charlotte Maxeke Johannesburg Academic Hospital and in the

development of the Institute’s maternal health team. Prior to joining WRHI Dr Black worked in internal medicine and microbiology. Dr Black is a member of the South African National AIDS Council, where she is the Civil Society Chair of the Treatment Care and Support Technical Team.

Dr Vinodh Aroon Edward, Director: Research Operations Dr Vinodh Edward’s role involves establishing, maintaining and monitoring the Research Operations function within WRHI. This includes providing centralised support in the areas of laboratory, pharmacy, data management, regulatory compliance and community outreach to WRHI’s research focus areas. Dr Edward completed a Bachelor of Science (BSc) degree in Microbiology and Physiology at the University of Durban-Westville (now University of KwaZuluNatal) and holds a Doctor of Technology (DTech) degree in Biotechnology from the Durban University of Technology. He joined the WRHI as a Technical Adviser in May 2009. He then headed

Wits Reproductive Health & HIV Institute

the Research Centre Programmes until his appointment as Director: Research Operations. Prior to joining the Institute, Dr Edward worked as a senior biotechnologist at the Council for Scientific and Industrial Research (CSIR), as a Senior Scientist at the Medical Research Council (MRC) and more recently as a Programme Manager at the National Institute for Communicable Diseases (NICD). Dr Edward has worked with many wellrespected scientists and has published extensively in the field of basic sciences. Dr Edward left WRHI in March 2012.

Our Staff At 31/12/11 Total staﬀ 574

At 01/10/10 Total staﬀ 407

male

93 23%

138 24%

female

436 76%

314 77%

Employment Equity as at 01/10/10

female

African Male

Employment Equity as at 31/12/11

African Male

African Female

Indian Male

Indian Female

Coloured Male

Coloured Female

White Male

White Female

The WRHI staff complement has increased by 41% over the reporting period, but our employment equity ratios have remained largely unchanged, with excellent representation from previously disadvantaged groups. WRHI encourages and supports staff in the pursuit of further education. Nine staff hold PhDs, 36 hold Master’s degrees, and 12 staff were pursuing tertiary qualifications during the reporting period, with three graduating in 2011.

recruitment – staff go through CVs

ANNUAL REVIEW 2010-2011

Financial Review As the Institute has grown in size and stature, so our financial resources have increased accordingly. Our expenditure has increased by over 300% in the last five years. Health Programmes is our largest area of expenditure, followed by Research. Health Programmes: health systems strengthening, research & advocacy Research Hillbrow Health Precinct Training Strategy & Development Operations Community Programmes Epidemiology & Biostatistics

Some of the North West team in relaxed mood

Wits Reproductive Health & HIV Institute

WRHI Publications October 2010 – December 2011 1. Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, JeanPhilippe P, Violari A, Antiretroviral Treatment for Children with Peripartum Nevirapine Exposure. The New England Journal of Medicine. 363(16):p1510-1520 2. Osih RB, Taffe P, Rickenbach M, Gayet-Ageron A, Elzi L, Fux C, Opravil M, Bernasconi E, Schmid P, Gunthard HF, Cavassini and the Swiss HIV Cohort Study, Outcomes of patients on dual-boosted PI regimens: Experience of the Swiss HIV Cohort Study. AIDS Research & Human Retroviruses. 26(11):p1239-1246 3. Stadler J, Saethre E, Rumours about blood and reimbursements in a microbicide gel trial. African Journal of AIDS Research. 9(4):p345-353 4. Wallis CL, Venter WDF, Stevens WS, Papathanasopoulos MA, Case report of the rare deletion at codon 69 of reverse transcriptase in a South African HIV-1 subtype C infected patient. Virus Genes. 41(3):p358-360 5. Bello B, Kielkowski D, Heederik D, Wilson K, The infertile-worker-effect in a South African Population. Occupational Health Southern Africa. 17(1): p21-23 6. Low N, Chersich MF, Schmidlin K, Egger M, Francis SC, van de Wijgert JHHM, Hayes RJ, Baeten JM, Brown J, Delany-Moretlwe S, Kaul R, McGrath N, Morrison C, Myer L, Temmerman M, van der Straten A, WatsonJones D, Zwahlen M, Hilber AM, Intravaginal Practices, Bacterial Vaginosis, and HIV Infection in Women: Individual Participant Data Meta-Analysis. PLoS Medicine. 8(2): e1000416 doi: 10.1371/journal.pmed.1000416 7. Stadler J, Saethre E, Blockage and flow: intimate experiences of condoms and microbicides in a South African clinical trial. Culture Health and Sexuality. DOI:10.180/ 13691058.2010.511270 8. Banerjee J, Klausner JD, Halperin DT, Wamai R, Schoen E, Moses S, Morris BJ, Bailis SA, Venter WDF, Martinson N, Coates TJ, Gray G, Bowa K, Circumcision Denialism Unfounded & Unscientific. American Journal of Preventive Medicine. 40(3)e11-e12 9. Frohoff C, Moodley M, Fairlie L, Coovadia A, Moultrie H, Kuhn L, Meyers T, Antiretroviral Therapy Outcomes in HIVInfected Children after Adjusting Protease Inhibitor Dosing during Tuberculosis Treatment. PLoS ONE. 6(2): e17273 10. Davies MA, Moultrie H, Eley B, Rabie H, Van Cutsem G, Giddy J, Wood R, Technau K, Keiser O, Egger M, Boulle A for the International Epidemiologic Databases to Evaluate AIDS Southern Africa (IeDEA-SA) Collaboration, Virologic Failure and Second-Line Antiretroviral Therapy Children in South Africa –The IeDEA Southern Africa Collaboration. Journal of Acquired Immune Deficiency Syndromes. 56(3):p270-278 11. Mujugira A, Morrow RA, Celum C, Lingappa J, DelanyMoretlwe S, Fife KH, Hefffron R, De Bruyn G, Homawoo B, Karita E, Mugo N, Vwalika B, Baeten JM for the Partners in Prevention HSV/HIV Transmission Study Team, Performance of the Focus HerpeSelect-2 enzyme

immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries. BMJ Sexually Transmitted Infections. 87(3): p238-241 12. Okal J, Chersich MF, Tsui S, Sutherland E, Temmerman M, Luchters S, Sexual and physical violence against female sex workers in Kenya: a qualitative enquiry. AIDS Care. 23(5):p612-618 13. Scott LE, Crump JA, Msuya E, Morrissey AB, Venter WDF, Stevens WS, Abbott RealTime HIV-1 m2000rt viral load testing: Manual extraction versus the automated m2000sp extraction. Journal of Virological Methods. 172(1-2):p78-80 14. Sprague C, Chersich MF, Black V, Health system weaknesses constrain access to PMTCT and maternal HIV services in South Africa: a qualitative enquiry. AIDS Research and Therapy. 8(10) doi:10.1186/1742-6405-8-10 15. Baeten JM, Kahle E, Lingappa JR, Coombs RW, DelanyMoretlwe S, Nakku-Joloba E, Mugo NR, Wald A, Corey L, Donnell D, Campbell MS, Mullins JI, Celum C, Genital HIV1 RNA Predicts Risk of Heterosexual HIV-1 Transmission. Science Translational Medicine. 3(77): 77ra29 16. Bello B, Fadahun O, Kielkowski D, Nelson G, Trends in lung cancer mortality in South Africa: 1995 – 2006. BMC Public Health. 11:a209 17. Edward VA, Huch M, Dortu C, Thonart P, Egounlety M, Van Zyl PJ, Singh S, Holzapfel WH, Franz CMAP, Biomass production and small-scale testing of freezedried lactic acid bacteria starter strains for cassava fermentations. Food Control 22(3-4):p389-395 18. Jarvis JN, Harrison TS, Govender N, Lawn SD, Longley N, Bicanic T, Maartens G, Venter WDF, Bekker LG, Wood R, Meintjies G, Routine cryptococcal antigen screening for HIV-infected patients with low CD4+ T-lymphocyte counts – time to implement in South Africa? South African Medical Journal. 101(4):p232-234 19. Kielkowski D, Nelson G, Bello B, Kgalamono S, Phillips JI, Trends in mesothelioma mortality rates in South Africa: 1995-2006. Occupational & Environmental Medicine. 68(7):p547-549 20. Park BJ, Shetty S, Ahlquist A, Greenbaum A, Miller JL, Motsi A, McCarthy K, Govender N, for the Gauteng Cryptococcal Surveillance Initiative Group, Long-term follow-up and survival of antiretroviral-naïve patients with cryptococcal meningitis in the pre-antiretroviral therapy era, Gauteng Province, South Africa. International Journal of STD & AIDS. 22(4):p199-203 21. Nyasulu JY, Nyasulu P, Barriers to the uptake of prevention of mother to child transmission (PMTCT) services in rural Blantyre and Balaka districts, Malawi. Journal of Rural and Tropical Health. 10:p48-52 22. Venter WDF, Ndung’u T, Abdool Karim A, Case 152011: A 19-Year-Old South African Woman with Headache, Fatigue and Vaginal Discharge. New England Journal of Medicine. 364:p1956-64 23. Vickerman P, Devine A, Foss AM, Delany-Moretlwe S, Mayaud P, Meyer-Rath G, The Cost-Effectiveness of Herpes Simplex Virus-2 Suppressive Therapy With Daily Aciclovir for Delaying HIV Disease Progression Among HIV-1-Infected Women in

ANNUAL REVIEW 2010-2011

52 South Africa. Sexually Transmitted Diseases. 38(5):p401-401 24. Black V, Sprague C, Chersich M, Interruptions in payments for lay counsellors impacts on HIV testing in antenatal clinics in Johannesburg, South Africa. SAMJ. 101(6):p407-408 25. Rees H, Madhi SA, Will the Decade of Vaccines mean business as usual? The Lancet. 378(9789):p382-385 26. Schwartz SR, Mehta SH, Taha TE, Rees HV, Venter F, Black V, High Pregnancy Intentions and Missed Opportunities for Patient-Provider Communication About Fertility in a South African Cohort of HIV-Positive Women on Antiretroviral Therapy. AIDS Behaviour. DOI:10.1007/s10461-011-9981-3 27. Steffenson AE, Pettifor AE, Seage GR, Rees HV, Cleary PD, Concurrent Sexual Partnerships and Human Immunodeficiency Virus Risk Among South African Youth. Sexually Transmitted Diseases. 38(6):p459-466 28. Van der Merwe KJ, Hoffman R, Black V, Chersich MF, Coovadia A, Rees HV, Birth outcomes in South African Women Receiving Highly Active Antiretroviral Therapy – a Retrospective Observational Study. Journal of the International AIDS Society 14:42 29. Jacobs ST, Baeten JM, Hughes JP, Peinado J, Wang J, Sanchez J, Reid SE, Delany-Moretlwe S, Cowan F, Fuchs JD, Koblin B, Griffiths S, Wald A, Celum C., A Post-Trial Assessment of Factors Influencing Study Drug Adherence in a Randomised Biomedical HIV-1 Prevention Trial. Aids & Behaviour. 15(5):p897-904 30. Scott L, McCarthy K, Gous N, Nduna M, Van Rie A, Sanne I, Venter WDF, Duse A, Stevens W, Comparison of Xpert MTB/ RIF with Other Nucleic Acid Technologies for Diagnosing Pulmonary Tuberculosis in a High HIV Prevalence Setting: A Prospective Study. PLoS Medicine. 8(7):e1001061 31. Black V, Sprague C, Woolman S, The constitutional justification and the ethical arguments for granting enhanced HIV treatment for selected priority groups in South Africa’s antiretroviral treatment programme. Journal of South African Law 2011, 3:p496-511 32. Delany-Moretlwe S, Stadler J, Mayaud P, Rees H, Investing in the Future: Lessons learnt from communicating the results of HSV/HIV intervention trials in South Africa. Health Res Policy and Syst. 2011 Jun 16;9 Suppl 1:S8 33. Hong HA, Loubser AS, de Assis Rosa D, Naranbhai V, Carr W, Paximadis M, Lweis DA, Tiemessen CT, Gray CM, Killer-cell immunoglobulin-like receptor genotyping and HLA killer-cell immunoglobulin-like receptor-ligand identification by realtime polymerase chain reaction. Tissue Antigens. 78:p185-194 34. Meyers TM, Yotiebeng M, Kuhn L, Moultrie H, Antiretroviral Therapy Responses Among Children Attending a Large Public Clinic in Soweto, South Africa. Journal of Paediatric Infectious Diseases 2011. 30(000-000) 35. Pettifor A, MacPhail C, Corneli A, Sibeko J, Kamanga G, Rosenberg N, Miller WC, Hoffman I, Rees H, Cohen MS, Continued High Risk Sexual Behaviour Following Diagnosis with Acute HIV Infection in South Africa and Malawi: Implications for Prevention. AIDS and Behaviour. 15(6):p1243-1250 36. The TREAT Asia Paediatric HIV Network, IeDEA Southern Africa Paediatric Group (Moultrie, H), A bioregional survey and review of first-line treatment failure and second-line paediatric antiretroviral access and use in Asia and southern Africa. Journal of the International AIDS Society 2011. 14(7)

37. Tulloch O, Mayaud P, Adu-Sarkodie Y, Opoku BK, Lithur NO, Sickle E, Delany-Moretlwe S, Wambura M, Changalucha J, Theobald S, Using research to influence sexual and reproductive health practice and implementation in Sub-Saharan Africa: a case-study analysis. Health Res Policy Syst. 2011 Jun 16;9 Suppl 1:S10 38. Venables E, ‘We are proud of this tower’: health and high-rises in inner-city Johannesburg. Etnofoor, Architecture. 23(1): p124-143 39. Were E, Curran K, Delany-Moretlwe S, Nakku-Joloba E, Mugo NR, Kiarie J, Bukusi EA, Celum C, Baeten JM for the Partners in Prevention HSV/HIV Transmission Study Team, A Prospective Study of Frequency and Correlates of Intimate Partner Violence among African Heterosexual HIV Serodiscordant Couples. AIDS 2011 Aug 5. [Epub ahead of print] 40. Pettifor A, Levandowski B, MacPhail C, Miller B, Ford C, Stein C, Rees H, Cohen M, A tale of two countries: Rethinking the HIV risk behaviours of adolescents in the US and South Africa. Journal of Adolescent Health. 49(2011):p237-243 41. Mugo NR, Heffron R, Donnell D, Wald A, Were EO, Rees H, Celum C, Kiarie JN, Cohen CR, Kayintekore K, Baeten JM; for the Partners in Prevention HSV/HIV Transmission Study Team, Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1 serodiscordant couples. AIDS. 2011 Sep 24;25(15):1887-1895 42. Heffron R, Mugo N, Rees H, de Bruyn G, Nakku-Joloba E, Celum C, Donnell D, Coombs R, Hormonal contraceptive use and risk of HIV-1 transmission: a prospective cohort analysis. Lancet Infectious Diseases. Oct 2011: 1-8 43. Mastro TD, Cohen MS, Rees H, Antiretrovirals for safer conception for HIV-negative women and their HIV-1-infected male partners: how safe and how available? AIDS. 25:p2049-2051 44. Nyasulu JY, Nyasulu P, Decision-making for women to access prevention of mother to child transmission services in Blantyre and Balaka Districts, Malawi. Journal of Rural Tropical Public Health. 10:p95-100 45. Faal M, Naidoo N, Glencross DK, Venter WDF, Osih R, Providing Immediate CD4 Count Results at HIV Testing Improves ART Initiation. Journal of Acquired Immune Deficiency Syndrome 46. Hallett TB, Baeten JM, Heffron R, Barnabas R, de Bruyn G, Cremin I, Delany-Moretlwe S, Garnett GP, Gray G, Johnson L, McIntyre J, Rees H, Celum C, Optimal Uses of Antiretrovirals for Prevention in HIV-1 Serodiscordant Heterosexual Couples in South Africa: A Modelling Study. PLoS Med. 8(11):e1001123 47. Venables E, Stadler J, “The study has taught me to be supportive of her”: Empowering women and involving men in microbicide research. Culture, Health and Sexuality. Nov. OI:10.1080/ 13691058.2011.630757 48. Fairlie L, Beylis NC, Reubenson G, Moore DP, Madhi SA, High prevalence of childhood multi-drug resistant tuberculosis in Johannesburg, South Africa: a cross sectional study. BMC Infectious Diseases. 11:28 49. Innes S, Cotton M, Venter WDF, Why should we still care about the stavudine dose? SA J HIV Med. 12:p.14-15 50. O’Connor C, Osih R, Jaffer A, Follow-up of stable antiretroviral therapy patients in a decentralised down-referral model of care in Johannesburg, South Africa. Journal of Acquired Immune Deficiency Syndromes. 58(4):p429-32

Wits Reproductive Health & HIV Institute

WRHI Conference Presentations and Posters October 2010 – December 2011 1. Visual Hillbrow: male explorations of health and space in Johannesburg, South Africa; E Venables; 9th International Conference on Urban Health; New York (oral presentation) 2. Know your epidemic, know your response: the need to contextualise HIV interventions in urban informal Johannesburg; E Venables; 9th International Conference on Urban Health; New York (oral presentation) 3. Child witnesses of domestic violence: the overlooked victims; Nataly Woollett; OVC in Africa Conference; Johannesburg (oral presentation) 4. Community-based intervention for children and adolescents: peace-building and nonviolence; Nataly Woollett; OVC in Africa Conference; Johannesburg (poster) 5. City Views: exploring visual representations of urban health & migration in Johannesburg through participatory photography and film projects; E Venables; OVC in Africa Conference; Johannesburg (oral presentation) 6. Navigating the verbal/nonverbal continuum: the value of creative arts therapies in transforming trauma; Nataly Woollett; ISTSS; Montreal (oral presentation) 7. New Paediatric ART issue; Hermien Gous; Rational Management of Medicines – A focus on HIV-AIDS, TB & Malaria; Pretoria (invited speaker) 8. HIV prevention trials: successes, challenges and future directions; Sinead Delany-Moretlwe; 3rd HIV & AIDS in the Workplace Research Conference; Johannesburg (keynote speaker) 9. Generics in Clinical Trials; Hermien Gous; IMPAACT Leadership Retreat; Atlanta, Georgia (oral presentation) 10. Gelling Medical Knowledge in a Microbicide Clinical Trial: Innovative Pharmaceuticals, Experience, and Perceptions of Efficacy; Eirik Saethre and Jonathan Stadler; American Anthropological Association; New Orleans, Louisiana (oral presentation) 11. Effect of periodic presumptive treatment on prevalence of STIs in female sex workers: cluster-randomised controlled trial; S Delany-Moretlwe, B Bello, H Rees; 6th PHASA 2010; East London, South Africa (oral presentation) 12. Underlying and proximate determinants of HIV infection in South African long-distance truck drivers; B Bello, S Delany- Moretlwe, M Chersich, H Rees; 6th PHASA 2010; East London, South Africa (oral presentation) 13. A prospective investigation of the data transfer process in primary health care facilities in region F, Johannesburg; S P Nani, S B Gumede, J N Soomar, S T Lalla-Edward; 6th PHASA 2010; East London, South Africa (poster)

14. Baseline assessment findings of the data transfer processes in primary health care facilities in Region F, Johannesburg; S P Nani, S B Gumede, J N Soomar, S T Lalla-Edward; 6th PHASA 2010; East London, South Africa (poster) 15. A model for evaluating outcomes of integrated voluntary counselling and testing programmes at primary health care facilities; J Soomar, S Ncube, F Bianchi, T Moshe, NP Naidoo; 6th PHASA 2010; East London, South Africa (poster) 16. An outcome evaluation of a Primary Health Care model for Voluntary Counselling and Testing in the inner city of Johannesburg; S Ncube, F Bianchi, T Moshe, NP Naidoo; 6th PHASA 2010; East London, South Africa (poster) 17. What men who have sex with men recommend to improve public health service delivery; Lalla-Edward, S; 6th PHASA 2010; East London, South Africa (poster) 18. Health care experience of men who sleep with men from the Johannesburg City; Lalla-Edward, S; 6th PHASA 2010; East London, South Africa (poster) 19. An Evaluation of a Mobile Clinic Providing Sexual Reproductive Health Services in Region F, Johannesburg; Ncube S, Soomar J, Maphanga P, Jankelowitz, L, Naidoo NP; 6th PHASA 2010; East London, South Africa (poster) 20. Assessment of challenges to monitoring and evaluation in Johannesburg Inner City primary health care sites; M Matsane, C O’Connor, R Ngubeni, A Jaffer; 6th PHASA 2010; East London, South Africa (oral presentation) 21. Predictors of loss to follow-up among stable HIV patients: results of a down-referral file audit; C O’Connor, R Ngubeni, A Jaffer; 6th PHASA 2010; East London, South Africa (poster) 22. Perceptions of integrating TB and HIV services: in-depth interviews with TB nurses in inner-city Johannesburg; C O’Connor, M Motimele, K McCarthy, N Naidoo; 6th PHASA 2010; East London, South Africa (oral presentation) 23. Genital HIV-1 RNA Levels predict risk of heterosexual HIV1 transmission; J Baeten, E Kahle, J Lingappa, R Coombs, S Delany-Moretlwe, E Nakku-Joloba, N Mugo, A Wald, L Corey & C Celum; CROI 2011; Boston (oral presentation) 24. Impact of TB/HIV integration on screening, diagnosis and management of co-infected individuals in inner city Johannesburg; Naidoo, NP, O’Connor, C, and McCarthy, K; 5th International Workshop on HIV Treatment, Pathogenesis and Prevention Research in Resource Limited Settings, INTEREST; Dar Es Salaam (oral presentation) 25. An outcome evaluation of an HIV Counselling and Testing programme in an inner city primary health care clinic, Johannesburg; Naidoo NP, Soomar JN, Ncube S,

ANNUAL REVIEW 2010-2011

54 Bianchi F; 5th International Workshop on HIV Treatment, Pathogenesis and Prevention Research in Resource Limited Settings, INTEREST; Dar Es Salaam (poster) 26. Point-of-care CD4 improves ART initiation rates but pre-ART losses remain high; Faal M, Naidoo N, Glencross D, Venter WDF, Osih R.; 5th International Workshop on HIV Treatment, Pathogenesis and Prevention Research in Resource Limited Settings, INTEREST; Dar Es Salaam (oral presentation) 27. Evaluation of the baseline pre-HAART chest x-ray in paediatric patients; Mahomed N, Mbakaza M, Sawry S, Moultrie HJA, Van Rie A; International Paediatric Radiology Congress; London (oral presentation & poster) 28. Atypical suprasellar presentation of a Rhabdoid/Teratoid tumour in a child; Nasreen Mahomed; International Paediatric Radiology Congress; London (poster) 29. An unusual presentation of an intra-abdominal rhabdomyosarcoma; Nasreen Mahomed; International Paediatric Radiology Congress; London (poster) 30. Disseminated rhabdomyosarcoma; Nasreen Mahomed; International Paediatric Radiology Congress; London (poster) 31. Clinical Pharmacy in South Africa – 21 years; Gous H & Gous A; South African Society of Clinical Pharmacy; Pretoria (invited speaker) 32. CD4 count delivery by SMS is acceptable to patients presenting for HIV counselling and testing; M Masote, M Faal, N Naidoo, R Osih; SA AIDS Conference; Durban (poster) 33. Communicating the City: exploring visual representations of urban health, HIV and migration in Johannesburg through participatory photography and film projects; Emilie Venables & Jo Vearey; SA AIDS Conference; Durban (oral presentation) 34. Un-focused groups and silent interviews: the ethical and methodological challenges of conducting HPV vaccine acceptability research with young South African males; Emilie Venables, Catherine MacPhail, Sinead Delany-Moretlwe; SA AIDS Conference; Durban (oral presentation & poster) 35. “I felt nervous at first, but now I am cool with it!”: Experiences of recruiting men to AfrEVacc 001, a vaccine feasibility and acceptability study in Hillbrow, Johannesburg; Emilie Venables, Nina von Knorring, Vinodh Edward, Sinead Delany-Moretlwe; SA AIDS Conference; Durban (poster) 36. A Day in the Life of a NIMART Nurse; Natasha Davies & Mamsallah Faal; SA AIDS Conference; Durban (poster) 37. A Programmatic Review of Supporting NIMART Rollout at a CCMT Site in Johannesburg; Natasha Davies & Mmakhukhu Masote; SA AIDS Conference; Durban (poster) 38. Effect of an intensive case management programme on ART initiations at a tertiary referral centre; Regina Osih; SA AIDS Conference; Durban (poster) 39. Sub-district-wide evaluation of facility TB infection control practices in North West and Gauteng Provinces; V Gharbaharan, K McCarthy , W Moleko, N Mfecane, M Khotseng, R Osih; SA AIDS Conference; Durban (poster) 40. Successful Outcomes of Prison Inmates on Highly Active

Antiretroviral Therapy in Soweto; Natasha Davies & Prof Alan Karstaedt; SA AIDS Conference; Durban (poster) 41. Coverage and predictors of ARV prophylaxis to HIVexposed infants at the time of delivery in a rural subdistrict of South Africa; Caitlin Matson, Glenrose Kraai, Harry Moultrie; SA AIDS Conference; Durban (poster) 42. Barriers to Uptake of Prevention of Mother to Child Transmission (PMTCT) Services in rural Blantyre and Balaka Districts in Malawi; Nyasulu JCY, Nyasulu P; SA AIDS Conference; Durban (oral presentation) 43. A Review of 2008 National Tuberculosis Control Programme (NTBCP) Data from a Johannesburg Primary Municipal Health Care Clinic (PHC); K McCarthy, A Barnard, J Moll, A van der Nest, O Montsioa, P Magingxa, F Venter; SA AIDS Conference; Durban (poster) 44. AfrEVacc 001 baseline demographic and sexual health screening data for male participants in Hillbrow, Johannesburg; Nina von Knorring, Catherine MacPhail, Jonathan Stadler, Emilie Venables, Vinodh Edward, Helen Rees, Sinead Delany-Moretlwe; SA AIDS Conference; Durban (poster) 45. I heard about the study for the first time on the radio: Community Radio as a tool for engaging the community in clinical trials; B Saxon, J Stadler, S Delany-Moretlwe; SA AIDS Conference; Durban (oral presentation) 46. Awareness of HIV Status is Associated with Protective Behaviours in South African HIV-1 Sero-discordant Couples; Rosenberg N, Pettifor A, Miller B, DelanyMoretlwe S, Coetzee D, De Bruyn G, Kamupira M; SA AIDS Conference; Durban (poster) 47. Predictors of Loss to Initiation in Inner City Johannesburg; Naidoo NP, Faal M, Venter WDF & Osih R; SA AIDS Conference; Durban (poster) 48. Combined treatment outcomes from public sector ART rollout sites in Gauteng and North West Provinces, South Africa; Naidoo NP, Ncube S, Venter WDF & Jaffer A; SA AIDS Conference; Durban (poster) 49. Baseline assessment findings of the data transfer processes in primary health care facilities in Region F, Johannesburg; Nani S, Gumede SB, Soomar JN, LallaEdward ST; SA AIDS Conference; Durban (poster) 50. Impact of non-antenatal attendance on Prevention of Motherto-Child Transmission; S Gumede, M Gulley, C von Mollendorf, P Sikhakhane, V Black; SA AIDS Conference; Durban (poster) 51. Improving the coverage of the PMTCT programme through participatory quality improvement methodologies in three sub-districts of Ngaka Modiri Molema District Municipality, North West Province, South Africa; N Mangale, P Masike, B Magano, P Lerite, B Moalusi, G Kraai; SA AIDS Conference; Durban (oral presentation) 52. An evaluation of a mobile clinic in providing sexual and reproductive health; Ncube S, Soomar J, Maphanga P, Jankelowitz, L, Naidoo NP; SA AIDS Conference; Durban (poster)

Wits Reproductive Health & HIV Institute

55 53. A retrospective follow-up of recipients and non-recipients of INH prophylactic therapy delivered as part of routine care to HIV-seropositive persons attending primary health care clinics in inner city Johannesburg; McCarthy K, Gharbaharan V, Matlapeng P, Ratshefola M, Tellie M, Sibanyoni M, Venter WDF; SA AIDS Conference; Durban (poster) 54. Outcomes of HIV-Positive Sex Workers; M Sibanyoni, C Gay, WDF Venter, K Klaas, N Motlokoa; SA AIDS Conference; Durban (oral presentation) 55. The Women at Risk Programme in Hillbrow – sex worker access to health care services; M Sibanyoni, C Gay, WDF Venter, N Motlokoa; SA AIDS Conference; Durban (poster) 56. Recommendations to improve public health service delivery for men who have sex with men (MSM); LallaEdward ST; SA AIDS Conference; Durban (poster) 57. The implicit contribution of hegemony and conforming on HIV transmission through men who have sex with men having families; Samanta LallaEdward; SA AIDS Conference; Durban (poster) 58. Health and HIV risk assessment of men who have sex with men (MSM) in the Johannesburg inner city; Samanta Lalla-Edward; SA AIDS Conference; Durban (poster) 59. Helping our youth become Fit for Life, Fit for Work: a programme to improve employment prospects and HIV outcomes among South African youth; Ellen Crabtree, Nikki Schaay, Naomi Lince, Queen Makhubele; SA AIDS Conference; Durban (poster) 60. Identifying barriers and challenges in the provision of and access to care of HIV-infected women and children – results from focus group discussions with PHC nurses in Gauteng; Nataly Woollett, Mpefe Ketlhapile, Tammy Meyers; SA AIDS Conference; Durban (oral presentation) 61. ‘That is what makes them talk a lot’: diverse voices and diverse meanings in clinical trial narratives; Jonathan Stadler and Eirik Saethre; HIV, biomedicine and subjectivity panel; 1st International HIV Social Science & Humanities Conference; Durban (oral presentation) 62. Exploring the Concept of “Continuous Trauma” – learnings from work in Northern Ireland and thoughts linked to the SA context; Martin Murphy; Dave Stewart; Kirsten Thomson; Second National Symposium On Continuous Traumatic Stress In South Africa; Cape Town (oral presentation) 63. Risk factors associated with HIV acquisition: a comparative analysis of older and younger women who participated in the MDP301 trial in Johannesburg; A Nanoo, A Nagpal, H Moultrie, S Delany-Moretlwe and H Rees; ISSTDR; Quebec (poster) 64. Interpretation of Routine Data from a Youthfriendly Clinic in Region F, Johannesburg; Samanta Lalla-Edward; ISSTDR; Quebec (poster) 65. Neurodevelopmental delay among HIV-infected preschool children receiving antiretroviral therapy in Soweto, South Africa; Sarah Lowick, Shobna Sawry, Tammy Meyers; 3rd International Workshop on HIV Paediatrics; Rome (poster)

66. Women’s experience of PMTCT services in Johannesburg; Mpefe Ketlhapile, Tammy Meyers; 3rd International Workshop on HIV Paediatrics; Rome (poster) 67. Lay counsellor training in trauma and traumatic bereavement: interventions that promote psychosocial change and strengthen healthcare systems; Nataly Woollett; SAACAPAP Congress; Wits University, Johannesburg (oral presentation) 68. Piloting the feasibility and acceptability of Project CONNECT – a couples-based HIV prevention intervention among South African couples; A Pettifor, C MacPhail, J Sibeko, L Parker, Z Dubazana, A Gomih; IAS; Rome (e-poster) 69. Successful implementation of an integrated real-time clinic and patient management system in a large paediatric HIV clinic in Johannesburg; S Sawry and H Moultrie; HISA Conference; Johannesburg (oral presentation) 70. Child witnesses of domestic violence: The overlooked victims; Nataly Woollett; World congress of the world federation for mental health; Cape Town (poster) 71. Lay counsellor training in trauma and traumatic bereavement: Interventions that promote psychosocial change; Nataly Woollett, World congress of the world federation for mental health; Cape Town (poster) 72. New Paediatric ART issues; Hermien Gous, Rational Management of Medicines – A focus on HIV/AIDS, Tuberculosis and Malaria (Collaboration between Swiss Tropical and Public Health institute and MEDUNSA et al); Pretoria (invited speaker) 73. NiMART roll out to PHC facilities: a tool to increase access to care and reduced workload for referral facilities in Region F, Johannesburg; Nyasulu, JCY, Mazwi, S and Kgopa, M; PHASA Conference; Gauteng (oral presentation) 74. Outcomes from Routine Data Quality Assessments (RDQA) in Ekurhuleni district for HIV/AIDS programmes; S Gumede, M Motimele, M Matsane, P Sikhakhane, S Lalla-Edward; PHASA Conference; Gauteng (poster) 75. Psychosocial Support for HIV positive adolescents: What they need and what works; SK Randeria; SAHARA; Port Elizabeth (oral presentation) 76. Lay counsellor’s role in the health system; N Zwane and B Ngoma; SAHARA; Port Elizabeth (oral presentation) 77. Who decides? Gender, attitude and decision-making for women to join PMTCT services in rural Malawi; Nyasulu JCY, Nyasulu P; SAHARA; Port Elizabeth (oral presentation) 78. CD4 count delivery by SMS results in timely ART initiation; Masote M, Faal M, Naidoo NP, Osih R, 16th International Conference on AIDS and STIs in Africa (ICASA); Addis Ababa (oral presentation) 79. Fit for Life, Fit for Work: using KAP survey outcomes to refine and develop a programme to improve employment prospects and HIV outcomes among South African youth; Ellen Crabtree, Nikki Schaay, Naomi Lince, Queen Makhubele;, 16th International Conference on AIDS and STIs in Africa (ICASA); Addis Ababa (oral presentation)

ANNUAL REVIEW 2010-2011

WRHI Donors AIDS Fonds AIDS Vaccine Advocacy Coalition (AVAC) Altech Pty LTD Altron Pty LTD Bill & Melinda Gates Foundation Center for HIV-AIDS Vaccine Immunology (CHAVI) at Duke University CONRAD Discovery Foundation European Union FP7 Framework European and Developing Countries Clinical Trials Partnership (EDCTP) Family Health International (FHI) Ford Foundation Foundation Open Society Initiative (FOSI) Futures Group International International Food Policy Research Institute International Organization for Migration Johns Hopkins Bloomberg School of Public Health Kraft Foods South Africa National Institutes of Health (NIH), USA Presidentâ&#x20AC;&#x2122;s Emergency Plan for AIDS Relief (PEPFAR) Raith Foundation Royal Netherlands Embassy SA National Department of Health SA National Department of Science and Technology SA National Research Foundation (NRF) UK Department for International Development (DFID) United Nations Population Fund (UNFPA) United States Agency for International Development (USAID) University of North Carolina at Chapel Hill Vodacom Foundation Wellcome Trust World Health Organisation WRHI is grateful to all our donors for making our work possible.

Wits Reproductive Health & HIV Institute

A Brief History … RHRU (Reproductive and HIV Research Unit)

ECHO (Enhancing Children’s HIV Outcomes)

1994: RHRU was founded in 1994 by Helen Rees as a joint initiative between Department of Obstetrics and Gynaecology of the Wits Faculty of Health Sciences and the Greater Johannesburg Metropolitan Council.

1997: Paediatrician Dr Tammy Meyers started a weekly paediatric outpatient HIV clinic at Chris Hani Baragwanath Hospital in response to the HIV epidemic affecting children in Soweto. The clinic strove to provide the best possible palliative care to the attending children.

2000: RHRU was made an official research unit of the Wits Department of Obstetrics and Gynaecology.

1999: Dr Meyers was joined by other paediatric experts Prof Ashraf Coovadia, Prof Gayle Sherman and Dr Dalu Ndiwenito to establish the Wits Paediatric HIV Clinics (WPHC). The purpose of WPHC was to improve the management of paediatric HIV infection at the CHBH and the other Wits academic hospitals.

2002: RHRU was awarded the status of a WHO Collaborating Centre status by WHO’s Afro region and by WHO’s headquarters in Geneva. 2004: PEPFAR funding: rapid expansion to increase ARV access, and HIV service provision 2006: The WRHI moved its National Office to Hillbrow in the inner city of Johannesburg, where offices, research space for clinical trials, a major training centre and a community care centre have been established. 2007: RHRU was redesignated as a collaborating centre for the Reproductive Health and Research Division of WHO (became a collaborating centre for the division for the Integrated Management of Adult and Adolescent Illness (IMAI). 2008: RHRU office was established in Mafikeng, North West Province, to support the organisation’s health systems strengthening activities with the provincial health department. April 2010: RHRU Durban separated to become a separate entity, and formed MatCH 2010: WRHI was awarded Institute status by Wits University.

2000: Harriet Shezi Children’s Clinic (HSCC) opened. Dr Harry Moultrie joined the WPHC team. WPHC played a key role in advocating for treatment to become available for both children and adults in SA. 2004: HSCC reached 100 children with ARVs before the government’s national ARV roll-out programme commenced on 1 April 2004, and developed further expertise in the field. 2004: The ECHO project was established to expand the reach in terms of the provision of HIV paediatric care beyond the tertiary hospital setting. The project became a division of the Wits Health Consortium (Pty) Ltd, Wits University. 2010: ECHO had over 120 employees including paediatricians, doctors, nurses, psychologists, dieticians, trainers, counsellors, data clerks, epidemiologists and researchers, supporting a holistic approach to paediatric HIV prevention and care.

October 2010: WRHI was formed as a result of the merger between RHRU and ECHO, another Wits University research unit specialising in HIV in the paediatric population.

WRHI October 2010: RHRU and ECHO merged Combined entity granted ‘Institute’ status by the University of the Witwatersrand and renamed the Wits Reproductive Health and HIV Institute

2011 WRHI delivers

ANNUAL REVIEW 2010-2011

Abbreviations and Acronyms AfrEVacc AIDS ART ARV ASPIRE CANVAS CBO CHAVI DASH DOT DSMB FACTS FDA HARP HBV HCT HCV HHP HIV HPTN HPV HSS HSV-1 HSV-2 HVTN IEC IMPAACT IRIS LGBT M&E MDR-TB MSM MSMW MTCT MTN NGO NIAID NIH NNRTI NRTI NSDA NtRTI OAR OI PEP PEPFAR PrEP PI PLWHA PMTCT RNA RT SANAC STI TB THINK USAID WAVE WHO XDR-TB

African-European HIV Vaccine Development Network Acquired Immune Deficiency Syndrome Antiretroviral Therapy Antiretroviral A Study to Prevent Infection with a Ring for Extended Use Cancer Vaccine Acceptability Study Community-Based Organisation The Centre for HIV/AIDS Vaccine Immunology District Approach to Strengthening Health Directly Observed Therapy Data Safety Monitoring Board Follow-on African Consortium for Tenofovir Studies Food and Drug Administration (U.S.) HPV in Africa Research Partnership Hepatitis B Virus HIV Counselling and Testing Hepatitis C Virus Hillbrow Health Precinct Human Immunodeficiency Virus HIV Prevention Trials Network Human Papillomavirus Health Systems Strengthening Herpes Simplex Virus 1 Herpes Simplex Virus 2 HIV Vaccine Trials Network Information, Education and Communication International Maternal Paediatric Adolescents AIDS Clinical Trials Group Immune Reconstitution Inflammatory Syndrome Lesbian Gay Bisexual Transgender Monitoring and Evaluation Multiple Drug-Resistant TB Men Who Have Sex With Men Men Who Have Sex With Men and Women Mother-to-Child Transmission Microbicide Trials Network Non-Governmental Organisation National Institute of Allergy and Infectious Diseases National Institutes of Health Non-Nucleoside Reverse Transcriptase Inhibitor Nucleoside Reverse Transcriptase Inhibitor Negotiated Service Delivery Agreement Nucleotide Reverse Transcriptase Inhibitor Office of AIDS Research Opportunistic Infection Post-Exposure Prophylaxis Presidentâ&#x20AC;&#x2122;s Emergency Plan For AIDS Relief Pre-Exposure Prophylaxis Protease Inhibitor People Living with HIV/AIDS Prevention of Mother-to-Child Transmission Ribonucleic Acid Reverse Transcriptase South African National AIDS Council Sexually Transmitted Infection Tuberculosis TB, HIV, IRIS, Nutrition in Kids Study United States Agency for International Development Well-being of Adolescents in Vulnerable Environments World Health Organization Extensively Drug-Resistant Tuberculosis