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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069453-15
Application #
10057323
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Guerra, Maria Isabel
Project Start
2007-02-15
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Wits Health Consortium (Pty), Ltd
Department
Type
DUNS #
639391218
City
Parktown
State
Country
South Africa
Zip Code
2193
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
Cassim, Haseena; Otwombe, Kennedy; Lazarus, Erica et al. (2017) A retrospective case-cohort study comparing treatment outcomes in abacavir versus stavudine containing first line antiretroviral treatment regimens in children <3yrs old, at a paediatric programme based in Soweto, South Africa. PLoS One 12:e0180645
Kistan, Jesne; Laher, Fatima; Otwombe, Kennedy et al. (2017) Pulmonary TB: varying radiological presentations in individuals with HIV in Soweto, South Africa. Trans R Soc Trop Med Hyg 111:132-136
Corey, Lawrence; Gray, Glenda E (2017) Preventing acquisition of HIV is the only path to an AIDS-free generation. Proc Natl Acad Sci U S A 114:3798-3800
Adachi, Kristina; Xu, Jiahong; Ank, Bonnie et al. (2017) Cytomegalovirus Urinary Shedding in HIV-infected Pregnant Women and Congenital Cytomegalovirus Infection. Clin Infect Dis 65:405-413
Eshleman, Susan H; Hudelson, Sarah E; Redd, Andrew D et al. (2017) Treatment as Prevention: Characterization of Partner Infections in the HIV Prevention Trials Network 052 Trial. J Acquir Immune Defic Syndr 74:112-116

Showing the most recent 10 out of 58 publications