Wits RHI
Current projects
Current projects
HPTN 108/ PAUSE STUDY
The HPTN 108 Study, also known as the PAUSE Study, is a Phase 1, randomized, placebo-controlled trial investigating the safety, efficacy and tolerability of the combination of two long-acting broadly neutralizing antibodies (bNAbs), 3BNC117-LS-J and 10-1074-LS-J, in ART-treated adults living with HIV in sub-Saharan Africa. The study focuses on whether these bNAbs, administered through intravenous infusion, will be safe, well-tolerated, and capable of maintaining durable viral suppression in the absence of antiretroviral therapy (ART) during a monitored analytical treatment interruption (ATI).
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Operation Gophelega
Operation Gophelega kicked off in January 2022 and is one of the largest grants Wits RHI has ever received from the US President’s Emergency Plan for AIDS Relief and the US Centers for Disease Control and Prevention. Gophelega is at the heart of Wits RHI’s district support partnership programme and our largest health system strengthening initiative to date. The team are working alongside district health services in Tshwane and Ekurhuleni to improve and innovate the delivery of HIV and TB services.
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MOSAIC
Maximizing OptionS to Advance Informed Choice for HIV Prevention (MOSAIC). MOSAIC works across multiple countries to implement user-centered research and research translation efforts to identify, understand, and remove barriers to new product introduction, access, and use; coordinate and provide technical assistance to global, national, and subnational stakeholders to expedite product launch and scale-up; and strengthen the capacity of a wide range of local partners to perform essential functions that support the introduction of HIV prevention products.
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The HEat and HEalth African Transdisciplinary (HEAT) Center
The HEat and HEalth African Transdisciplinary (HE2AT) Center is a five-year project funded by the National Institutes of Health, Common Research Fund. It was launched in 2022 and consists of a data science and analytics platform that helps understand how extreme heat affects vulnerable groups in Africa.
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PALESA
A Pilot Randomized Controlled Trial to Assess a Model of Decentralised STI-Self Testing and Risk Self-Assessment Among Adolescent Girls and Young Women in South Africa to Trigger PrEP Re-start (PALESA). In South Africa (SA), adolescent girls and young women (AGYW) experience high rates of incident HIV infection. HIV pre-exposure prophylaxis (PrEP) has the potential to impact HIV incidence when used with consistent adherence to the required dosing schedule.
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APACE – Accelerating Program Achievements to Control the Epidemic
APACE: Accelerating Program Achievements to Control the Epidemic, Lejweleputswa District. Project Overview The Accelerating Program Achievements to Control the Epidemic (APACE) project is a partnership between Wits RHI and USAID to intensify the control of the HIV epidemic in South Africa, specifically in the Lejweleputswa District in the Free State.…
CoVPN 3008 (Ubuntu) TB Substudy
Tuberculosis Case Finding at the Completion of the Ubuntu Clinical Trial: A Substudy to CoVPN 3008 (Ubuntu) Project Overview The CoVPN 3008 (Ubuntu) TB Substudy is an observational project aimed at identifying undiagnosed tuberculosis (TB) cases, including subclinical TB, among participants of the CoVPN 3008 (Ubuntu) parent study. This substudy…
CHOMA
Combining HIV Prevention Options With Mental Health Service Delivery For Adolescent Girls (CHOMA). Youth Friendship Bench SA Optimization of the Friendship Bench mental health intervention for adolescent girls and young women in South African PrEP delivery settings -Youth Friendship Bench SA. Rationale The study aims to evaluate two primary outcomes…
IMPAACT 2017 Study
IMPAACT 2017 is a Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Rationale The IMPAACT 2017 study aims to assess the efficacy of a two-drug, long-acting injectable regimen—CAB LA and RPV…
PURPOSE 2 Study
PURPOSE 2 Study: A phase 3, double-blind, multicentre, randomised trial evaluating the safety and efficacy of twice-yearly long-acting subcutaneous Lenacapavir and daily oral Emtricitabine/Tenofovir Alafenamide for pre-exposure prophylaxis (PrEP) in cisgender men, transgender women, transgender men, and gender non-binary individuals at risk of HIV infection. Rationale Both daily oral emtricitabine/tenofovir…
PURPOSE 1 Study
PURPOSE 1 Study: A double-blinded, multicenter, randomized Phase 3 study aimed at assessing the safety and effectiveness of twice-yearly long-acting subcutaneous Lenacapavir, in combination with daily oral Emtricitabine/Tenofovir Alafenamide, for pre-exposure prophylaxis among adolescent girls and young women vulnerable to HIV infection. Rationale Daily use of F/TDF has proven highly…
HPTN 084 Study
HPTN 084: A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women Rationale PrEP may only reach its full potential for HIV prevention with agents that do not depend on daily or near-daily pill-taking. The development…
Jabula Uzibone Study
Jabula Uzibone Study: Transgender-specific Differentiated HIV Care Models – An Implementation Science Study Study Rationale Transgender people (TGP) in South Africa face severe healthcare challenges, including disproportionately high HIV rates due to stigma, discrimination, and limited access to appropriate healthcare services. Traditional service delivery models are often not tailored to…
HPTN 108/ PAUSE STUDY
HPTN 108 Study: Pausing Antiretroviral Treatment Under Structured Evaluation (PAUSE Study). The HPTN 108 Study, also known as the PAUSE Study, is a Phase 1, randomized, placebo-controlled trial investigating the safety, efficacy and tolerability of the combination of two long-acting broadly neutralizing antibodies (bNAbs), 3BNC117-LS-J and 10-1074-LS-J, in ART-treated adults…
IMPAACT 2036 CRAYON Study
The IMPAACT 2036 CRAYON Study is a Phase I/II clinical trial focused on evaluating the safety, tolerability, acceptability, and pharmacokinetics of oral and long-acting injectable formulations of cabotegravir (CAB) and rilpivirine (RPV) in virologically suppressed children living with HIV-1, aged 2 to less than 12 years. This innovative study seeks…
VAXART Study
VAXART Study: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 Years Old and Their Breastfeeding Infants. Rationale Noroviruses (NoVs) are a diverse group of small, nonenveloped, single-stranded…
The CATALYST Study
CATALYST: Catalysing Access to New HIV Prevention Products to Stop HIV Rationale The CATALYST implementation science study, under the MOSAIC Project, addresses the urgent need for innovative HIV prevention strategies for women in sub-Saharan Africa. Conducted in South Africa, Lesotho, Kenya, Zimbabwe, and Uganda, the study aims to accelerate the…
IMPAACT 2028
Long-Term Clinical, Immunologic, and Virologic Profiles of Children who Received Early Treatment for HIV. Rationale Early treatment of infants living with HIV offers a unique population in which to investigate long-term clinical, immunologic, and virologic outcomes and to better characterize how early ART impacts HIV infection over time. The overarching…
MATRIX-002
Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films. Rationale Topical microbicides play a crucial role in mitigating the risk of HIV transmission through sexual contact by applying them to the genital or rectal mucosa. Among various delivery options, vaginal films stand out as a compelling choice…
Technical Support National Department of Health for HIV Prevention & Pre-Exposure Prophylaxis
Rationale Whilst the Department of Health has made significant gains in the introduction and the scale- of oral pre-exposure prophylaxis as an HIV prevention intervention, at 78% of public PHC facilities support is required to achieve of PHC 100% coverage. In the following 2 years, the department will focus strengthening…
Coalition to Accelerate and Support Prevention Research (CASPR)
Coalition to Accelerate and Support Prevention Research (CASPR). Rationale The objective of this project is to bolster the development and longevity of an Africa-centered network dedicated to promoting advocacy, policy formulation, regulatory compliance, community involvement, and communication initiatives that facilitate the advancement of biomedical HIV prevention research. Here are the…
IMPAACT 2026
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drug during Pregnancy and Postpartum. Rationale The predecessor of this study, MPAACT P1026s, gained approval in 2003 and enrolled over 1000 pregnant/postpartum women. It investigated the pharmacokinetics (PK) of more than 25 HIV and TB drugs in these women, resulting in 27 published manuscripts…
ATN 168: HAPPY
Values and Preferences for a Novel, Systemic, Injectable Multipurpose Product for HIV and Pregnancy Prevention in Individuals Assigned Female at Birth in the United States (ATN 168: HAPPY) Rationale The HAPPY study aims to evaluate the preferences and values regarding a new injectable Multipurpose Prevention Technology (MPT) for preventing pregnancy…
EPIC
Evaluation of Pharmacokinetic drug-drug Interactions between hormonal Contraceptives and doravirine-containing ART among women living with HIV in South Africa (EPIC). Rationale While DOR-containing antiretroviral therapy (ART) has been studied in two large clinical trials, the representation of women, especially African women, has been disproportionately low at only 16-17% and 6-10%,…
Project PrEP
Project PrEP: Integrating PrEP into Comprehensive Services for Adolescent Girls and Young Women Rationale Project PrEP is a Unitaid-funded initiative that began in 2018, aimed at integrating oral PrEP into comprehensive sexual and reproductive health (SRH) services for adolescent girls and young women (AGYW). The project operates across eight fixed…
MTN 043
A Phase 3B randomized, open-label study to assess safety and drug detection of the Dapivirine Vaginal Ring and oral TRUVADA in breastfeeding Mother-Infant Pairs. Rationale This study is to assess the safety, drug detection, adherence, and acceptability of the DPV VR (25mg) administered every four weeks, and the once-daily Truvada…
IMPAACT 2023
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 Rationale New antiretroviral drugs (ARVs) are crucial for neonatal use, serving both as HIV transmission prophylaxis and treatment for newborns with HIV. Dolutegravir, a potent ARV with a robust resistance barrier, is widely…
UBOMI BUHLE
UBOMI BUHLE: Understanding Birth Outcomes for Mothers and Infants, Building Healthcare by Linking Exposures. A South African Pregnancy Exposure Registry focused on improving maternal and newborn healthcare. Rationale As South Africa rolls out new adult and Prevention of Mother-to-Child Transmission (PMTCT) treatment guidelines incorporating dolutegravir (DTG)-based antiretroviral therapy (ART) as…
Integrating PrEP into Comprehensive Services for Adolescent Girls and Young Women
AGYW in South Africa (aged between 15 and 24 years) have the highest HIV incidence, with young women in their early 20s having a four-fold burden compared to their male peers: approximately 1,745 new HIV infections occur in this cohort every week, and one third of teenage girls become pregnant…
SAMURAI
South African Male User Research on Acceptability of Implants and Injections (SAMURAI). Rationale Our prior formative research in Cape Town, South Africa, revealed a strong willingness among young people, both male and female, to use injectable and implantable HIV prevention products. Through the iPrevent Discrete Choice Experiment (DCE), our team…
Pausing Antiretroviral Treatment Under Structured Evaluation (PAUSE)
A Phase I, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Antiviral, and Immunomodulatory Effects of Combining Broadly Neutralizing Antibodies 3BNC117-LS-J and 10-1074-LS-J in ART-Treated Adults with HIV in sub-Saharan Africa, during a Monitored Analytical Treatment Interruption Period. Rationale Broadly neutralizing antibodies (bNAbs) have emerged as promising tools in addressing gaps…
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK8527-007)
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low Risk for HIV-1 Infection The purpose of this study is to assess the safety and tolerance of MK-8527 administered once monthly at doses of 3 mg, 6 mg,…
KK-1439-066
A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, who are 4 Weeks to less than 12 Years of Age and Weigh less than 45 kg. Rationale As in adults, the objective of ART in the pediatric…
GILEAD Study
GILEAD Study: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children. Study Rationale The advent of Highly Active Antiretroviral Therapy (HAART) and the benefits of maximally suppressed viremia have transformed HIV treatment,…
Operation Gophelega
Operation Gophelega: Strengthening HIV and TB Services in Gauteng’s Tshwane and Ekurhuleni Districts. Rationale and Objectives Operation Gophelega, launched in January 2022, represents one of the largest grants ever received by Wits RHI from the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Centers for Disease Control…
MOSAIC
Maximizing OptionS to Advance Informed Choice for HIV Prevention (MOSAIC). Rationale MOSAIC works across multiple countries to implement user-centered research and research translation efforts to identify, understand, and remove barriers to new product introduction, access, and use; coordinate and provide technical assistance to global, national, and subnational stakeholders to expedite…
MTN 042 Study
MTN 042 Study: Safety and Pharmacokinetic Trial of Dapivirine Vaginal Ring (VR) and Oral FTC/TDF Use in Pregnancy. Rationale The MTN 042 study is a multicenter, prospective, open-label, randomized Phase 3b trial aimed at evaluating the safety, adherence, and acceptability of the Dapivirine Vaginal Ring (25 mg) and Truvada (200…
SHIELD Study
A multicentre, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance. Rationale The dose selection of…
School Based HIV and Violence Prevention Programme (AGYW PrEP) – DREAMS
Adopting a socio-ecological approach, the programme aims to reduce the incidence of HIV infection and violence among adolescent girls and young women (AGYW) through the provision of SRH and PrEP services through differentiated service delivery at community-based sites. Rationale The USAID funded DREAMS initiative adopts a differentiated service delivery approach…
Pfizer RSV Vaccine Study In HIV-Infected Pregnant Woman
A Phase 3 trial has been initiated as a randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and immunogenicity of the Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in pregnant participants living with HIV and their infants. Maternal immunization stands as a promising strategy for preventing infant diseases.…
Market Shaping for long-acting generic PrEP market
Rationale Global efforts to scale up new long-acting PrEP options such as the dapivirine vaginal ring (DVR) and long-acting cabotegravir (CAB-LA), are some of the tools being deployed to end AIDS by 2030. These efforts will remain fundamentally curtailed by limited supply and high costs, therefore, it is important to…
D43 Wits-UNC Partnership: Expanding Capacity in HIV Implementation Science in South Africa
Rationale Despite significant progress in expanding antiretroviral therapy (ART) and HIV prevention like PrEP (Pre-exposure prophylaxis), South Africa (SA) remains a focal point of the global HIV epidemic. While there have been reductions in HIV incidence and mortality, challenges persist in effectively implementing HIV prevention and care, posing a major…
IMPAACT 2009
Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants Rationale Feasibility, Acceptability and Safety of pre-exposure prophylaxis during Pregnancy and Breast Feeding to establish drug thresholds for optimal adherence when FTC/TDF is administered daily…
Continued access to Etravirine in treatment experienced HIV-1 infected individuals
Rationale The aim of the study is to provide continuous access to Etravirine (ETR) for individuals who have completed a clinical study with ETR sponsored by or in collaboration with Janssen Research & Development. The primary objective is to continue the provision of ETR for subjects who previously received ETR…
GO-012
A Phase 1 SARS-CoV-2 Vaccine Study to Assess the Safety and Tolerability of GRT-R912 or GRT-R914 Administered as Prime and/or Boost in Healthy Adult Volunteers Naïve to SARS-CoV-2, SARS-CoV-2 Convalescent Subjects, and People Living with HIV. Rationale This Phase 1 clinical trial will assess the potential of Gritstone’s second-generation COVID-19…
BASIS Study
Phase II randomised open label trial of full and half dose J&J Ad26.CoV2.S and Pfizer BNT162b2 booster vaccinations after receiving the J&J Ad26.CoV2.S prime vaccine through the SISONKE phase IIIB implementation study. Rationale The study aims to assess the immunogenicity and effectiveness of boosting strategies for the J&J Ad26.COV2.S vaccine.…
South African Population Research Infrastructure Network (SAPRIN)
South African Population Research Infrastructure Network (SAPRIN): A GRT-INSPIRED Sub Study of COVID-19 Perceptions, Impacts and Seroprevalence Among Residents of Atteridgeville, Melusi and Hillbrow in Gauteng, South Africa Rationale The global COVID-19 pandemic is an exceptional emergency, and presents a serious risk to human health and livelihoods, especially in countries…
South Africa CATALYST Study
MOSAIC South Africa is excited to announce the official launch of the CATALYST (Catalyzing Access to New Prevention Products to Stop HIV) Study after months of preparation and anticipation. The launch was held at the Wits RHI Key Populations clinic in Johannesburg on 11 August 2023 and was attended by…
PROMISE
We propose to support early product introduction for the dapivirine ring through the Envision FP mechanism with the express goal of shaping the market and establishing a service delivery platform for future MPT VRs. The activity will be called PROMISE (Preparing for Ring Opportunities through Market Introduction Support and knowledge…
MATRIX: Advancing R&D Of Innovative HIV Prevention Products For Women
The Microbicide R&D to Advance HIV Prevention Technologies through Responsive Innovation and eXcellence (MATRIX) is a USAID Project initiated in 2022 to Advance the Research and Development of Innovative HIV Prevention Products for Women. MATRIX is implemented and co-led by Magee-Womens Research Institute and Foundation, USA, and Wits RHI. This…
TB Champ
A phase III cluster randomised placebo‐controlled trial to assess the efficacy of preventive therapy in child contacts of multidrug‐resistant (MDR) tuberculosis (TB). Rationale This trial specifically targets children less than five years for two reasons. First, children less than five years are at the highest risk of progressing to TB…
2019nCoV-505
A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M™Adjuvant in People Living with HIV. Rationale Novavax, Inc. is developing recombinant vaccines adjuvanted with the saponin-based Matrix-M adjuvant for the prevention of disease caused by SARS-CoV-2.…
BCG Revax Gates MRI
A Randomized, Placebo Controlled, Observer-Blind, Phase IIb Study to Evaluate the Efficacy, Safety, and Immunogenicity of BCG revaccination in Healthy Adolescents for the Prevention of Sustained Infection with Mycobacterium tuberculosis. Rationale The study is focused on evaluating the efficacy, safety, and immunogenicity of Bacillus Calmette-Guerin (BCG) revaccination in healthy adolescents…
ADVANCE
Wits RHI 060 (ADVANCE): A 96-week Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared with DTG + TDF + FTC and EFV + TDF+FTC in Patients Infected with HIV-1 Starting First-line Antiretroviral Therapy. Rationale The primary objective of this study is to demonstrate the non-inferiority of dolutegravir (DTG)…
Care & Treatment Sub Award, Tshwane Health District
Programmatic Implementation and Technical Assistance (TA) for HIV/AIDS and Tuberculosis (TB) Prevention, Care, and Treatment Services throughout the Health System in South Africa under PEPFAR – SA. Rationale South Africa is at the forefront of the global AIDS response and has made progress in the fight against HIV. Although the…
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Established in 1994, Wits RHI is part of the Faculty of Health Sciences and the largest research institute of the University of the Witwatersrand.