PHRU-Setshaba Clinical Trials Unit

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PROJECT SUMMARY/ABSTRACT 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.