HIV is the epidemic of our time; South Africa is its epicenter. Current interventions are denting the epidemic but are unlikely to achieve the UNAIDS goal of ending HIV by 2030. In South Africa, new infections continue: in 2018, 240 000 new infections added to the 7.7 million South Africans living with HIV. South Africa has the largest ARV program in the world, but treatment as prevention has not stalled new infections. Although progress has been made in controlling pediatric HIV, we have yet to meet the Joint United Nations Programme on HIV/AIDS (UNAIDS) elimination targets. The significant TB burden amongst people living with HIV destabilizes TB control efforts. Taken together, these realities underscore the need to find effective biomedical interventions to prevent HIV, address the long-term management of HIV throughout the age spectrum, and investigate HIV remission. Ongoing research investment is vital to our attempt to achieve epidemic control. NIH-sponsored research has led to vital advances in both treatment and prevention. Our proposed PHRU- Setshaba Clinical Trials Unit (CTU), with seven Clinical Research Sites (CRS), is strategically positioned in high HIV prevalence and incidence geographic hotspots. Our access to informal settlements, maternity units, TB clinics and hospitals enables the CTU to investigate the prevention and control of HIV and TB. Our PHRU- Setshaba CTU has the long-term objective to support the scientific agenda of the four NIH HIV/AIDS Clinical Trials Networks to reduce the impact of HIV and TB on infants, children, adolescents and adults. Our CTU comprises of internationally renowned scientists, based in South Africa, predominantly women, from diverse racial and ethnic backgrounds, with a track record of capacity development. To contribute to the scientific agenda of the NIH HIV/AIDS Clinical Trials Networks, the CTU intends to: 1) evaluate novel active HIV vaccination strategies that may be efficacious by inducing non-neutralizing vaccine immune responses; 2) evaluate passive neutralization utilizing one or more monoclonal antibodies for biomedical prevention; 3) investigate the role of alternatives to oral pre-exposure prophylaxis such as long-acting antiretrovirals and multi-purpose prevention technologies; 4) assess HIV vaccines to prevent breastmilk transmission of HIV; 5) contribute to finding HIV treatment options that reduce long-term side-effects in both adults and children; 6) support research into HIV remission and 7) to contribute to the TB research agenda for TB prevention and therapeutics.
We aim to achieve this by operating an efficient CTU that will oversee the execution of quality clinical research which is regulatory and ethically compliant, in partnership with our communities, as well as by developing a successor generation of diverse scientists.

Public Health Relevance

HIV and TB constitute major threats to human health. Progress in understanding and managing HIV has been revolutionary and rapidly translated into practice. For epidemic control, we still require an effective HIV vaccine, biomedical interventions to solve adherence issues in treatment and prevention, and a cure. Similarly, an effective TB vaccine must still be found.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1)
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Guerra, Maria Isabel
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Wits Health Consortium (Pty), Ltd
South Africa
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Swindells, S; Gupta, A; Kim, S et al. (2018) Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003). Int J Tuberc Lung Dis 22:1016-1022
Dietrich, Janan J; Lazarus, Erica; Andrasik, Michele et al. (2018) Mobile Phone Questionnaires for Sexual Risk Data Collection Among Young Women in Soweto, South Africa. AIDS Behav 22:2312-2321
Ramteke, Sarah M; Shiau, Stephanie; Foca, Marc et al. (2018) Patterns of Growth, Body Composition, and Lipid Profiles in a South African Cohort of Human Immunodeficiency Virus-Infected and Uninfected Children: A Cross-Sectional Study. J Pediatric Infect Dis Soc 7:143-150
Salazar-Austin, N; Kulich, M; Chingono, A et al. (2018) Age-Related Differences in Socio-demographic and Behavioral Determinants of HIV Testing and Counseling in HPTN 043/NIMH Project Accept. AIDS Behav 22:569-579
Thiam-Diouf, Arame; Metch, Barbara; Sharpe, Cameron et al. (2018) Substance use patterns of HVTN phase I clinical trial participants: Enrollment, risk reduction counseling and retention. Vaccine 36:1235-1242
Fogel, Jessica M; Clarke, William; Kulich, Michal et al. (2017) Antiretroviral Drug Use in a Cross-Sectional Population Survey in Africa: NIMH Project Accept (HPTN 043). J Acquir Immune Defic Syndr 74:158-165
Wall, Kristin M; Rida, Wasima; Haddad, Lisa B et al. (2017) Pregnancy and HIV Disease Progression in an Early Infection Cohort from Five African Countries. Epidemiology 28:224-232
Greer, Amy E; Ou, San-San; Wilson, Ethan et al. (2017) Comparison of Hepatitis B Virus Infection in HIV-Infected and HIV-Uninfected Participants Enrolled in a Multinational Clinical Trial: HPTN 052. J Acquir Immune Defic Syndr 76:388-393
Bekker, Linda-Gail; Gray, Glenda E (2017) Hope for HIV control in southern Africa: The continued quest for a vaccine. PLoS Med 14:e1002241
Riddler, Sharon A; Husnik, Marla; Ramjee, Gita et al. (2017) HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One 12:e0178594

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