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…
MATRIX-003 Study
OCIS Placebo Ring Study - MATRIX-003 Phase 1 (Placebo) Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Ring (IVR) Designs. Study Rationale The OCIS Placebo Ring Study, MATRIX-003, seeks to advance women’s sexual and reproductive health by testing the safety and acceptability of two placebo intravaginal ring (IVR) designs.…
HIGH Horizons (Heat Indicators for Global Health) Study
HIGH Horizons: Heat Indicators for Global Health. Monitoring, Early Warning Systems and health facility interventions for pregnant and postpartum women, infants and young children and health workers. Rationale The HIGH Horizons Study is designed to address critical knowledge gaps regarding the direct and indirect effects of heat exposure on maternal,…
DREAMS PrEP Choice Study
DREAMS PrEP Choice Study: Exploring Long-Acting HIV Prevention Options for Adolescent Girls and Young Women in Johannesburg. Study Overview The DREAMS PrEP Choice Study focuses on examining the acceptability and feasibility of long-acting HIV prevention methods, specifically the PrEP Ring and Injectable Cabotegravir (CAB-LA), for adolescent girls and young women…
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…
OptiMVacc-SA
OptiMVacc-SA: Optimizing Maternal Vaccinations in South Africa The OptiM-Vacc-SA project aims to evaluate the current landscape of maternal vaccine delivery in South Africa and provide recommendations for strengthening health systems. This initiative focuses on optimizing the delivery of existing maternal vaccines while preparing for the introduction of new vaccines. Implemented…
HOPE II Study
Human Papillomavirus One-Dose-vaccine Prevention Efficacy among Women Living with HIV (HOPE II) Study Study Rationale The HOPE II Study aims to explore whether a single-dose HPV vaccine can effectively prevent persistent HPV infections in women living with HIV, particularly targeting HPV strains linked to cervical cancer. This study focuses on…
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…
BIYELA STUDY
BIYELA: Bexsero Immunisation in Young Women in Africa. The BIYELA Study is a Phase 3 randomized, double-blinded, placebo-controlled trial evaluating the efficacy of the meningococcal serogroup B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection among individuals born female in South Africa. This study focuses on sexually transmitted infection (STI)…
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…
ABBOTT
Sample Collection for the Development and Evaluation of Rapid Tests for Chlamydia trachomatis and Neisseria gonorrhoeae – outside of US (OUS). Rationale Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are significant contributors to avoidable infertility. Many cases of CT and NG go undiagnosed and unreported, leading to frequent reinfection…
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…
GBS 6 Vaccine Study (C1091002)
A Phase 1/2 clinical trial has been designed as a randomized, placebo-controlled, observer-blinded study to assess the safety, tolerability, and immunogenicity of a multivalent group B Streptococcus (GBS) vaccine. This trial targets healthy nonpregnant women and pregnant women aged 18 to 40 years, along with their infants. Rationale GBS is…
PROVE
The Ancillary Study of ARISE: Validation of Selected Point-of-Care Rapid STI Diagnostic Tests for Laboratory-Based and Self-Testing. Rationale Sexually transmitted infections (STIs) like Chlamydia Trachomatis (CT), Neisseria Gonorrhea (NG), and Trichomonas Vaginalis (TV) pose significant health challenges in East and southern Africa, especially among younger women in South Africa. These…
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,…
GSK Neisseria gonorrhoeae GMMA (NgG)
A multi-country Phase 1/2 trial, conducted in an observer-blind, randomized, and placebo-controlled manner, aiming to evaluate the safety and efficacy of the GSK Neisseria gonorrhoeae GMMA (NgG) investigational vaccine in healthy adults aged 18 to 50 (NGG-001) Rationale To ascertain the effectiveness of the NgG vaccine in preventing cases of…
HOPE Study
The HOPE (HPV One and Two Dose Population Effectiveness) Study is investigating the impact of 1-dose and 2-dose human papillomavirus (HPV) vaccination schedules on the prevalence of HPV in South African adolescent girls. This research aims to evaluate the effectiveness of these vaccination schedules in reducing community-level HPV prevalence within…
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…
Group B Streptococcus Vaccine Study
A multicentre, multinational, parallel group, observer-blind, randomised, placebo- controlled study on the Group B Streptococcus vaccine (GBS-NN/NN2), investigating the immunogenicity and safety of four vaccination regimens in pregnant women, assessing IgG specific to AlpN proteins in cord blood, and the safety profile in mother and infant up to six months…
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). Rationale In South Africa (SA), adolescent girls and young women (AGYW) face significant rates of new HIV infections. HIV pre-exposure…
Integrating aetiologic testing for Chlamydia trachomatis and Neisseria gonorrhoeae using GeneXpert
Integrating aetiologic testing for Chlamydia trachomatis and Neisseria gonorrhoeae using GeneXpert® and treatment of sexually transmitted infections into primary health care services: a pilot study. Rationale Mathematical modeling indicates that implementing STI screening and treatment can greatly impact the overall incidence of STIs in a population. Focusing on screening through…
ARISE Study
ARISE: Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT) Rationale Rates of curable sexually transmitted infections (STIs) are rising globally, with South Africa experiencing some of the highest STI rates. Additionally, South Africa has the highest HIV-1 incidence, particularly among young…
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…
Rhyme (mRNA-1365-P101)
A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 months to 24 months. Rationalise There is no existing approved vaccine or specific therapy for RSV or hMPV infection. ALRI associated with these viruses remains a large…
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…
Heat Adaptation for Pregnant women and Infants (HAPI) study
Heat Adaptation for Pregnant women and Infants (HAPI) study Summary of the study Temperatures in Southern Africa are rising at twice the global rate, with major health implications for maternal and newborn health. In these conditions, the options for adaptation are limited, and single-component interventions are likely to be poorly…
Key Populations Programme
Wits RHI Key Populations Programme for Sex Workers and Transgender Individuals Programme Overview The Wits RHI Key Populations Programme is dedicated to advancing HIV prevention, care, and treatment for sex workers (SWs) and transgender (TG) individuals in South Africa. With a focus on reducing HIV incidence and improving access to…
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
A Phase 3 trial has been initiated as a randomized, double- or observer-blinded, placebo-controlled study to assess the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women who were vaccinated during pregnancy. Rationale The urgent medical need for an effective RSV…
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…
South African Population Research Infrastructure Network (SAPRIN)
South African Population Research Infrastructure Network (SAPRIN): A National Research Infrastructure of Health and Demographic Surveillance System (HDSS) Nodes. Rationale Research in the human and social sciences plays a crucial role in driving social, economic, and cultural development and transformation in South Africa. The overarching goal is to enhance the…
CHAMNHA (Climate, Heat, and Maternal and Neonatal Health in Africa)
Investigating the impact of environmental heat exposure around the time of childbirth on women's and children's health a community and facility-based qualitative inquiry in Burkina Faso and Kenya. Rationale The frequency and intensity of heat waves have increased in sub-Saharan Africa (SSA) and are set to escalate in the coming…
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…
Zoliflodacin Trial
Positive results announced in largest pivotal phase 3 trial of a first-in-class oral antibiotic to treat uncomplicated gonorrhoea. Our team at Wits RHI was proud to contribute to the success of this study in South Africa. Well done to the team !!! Prof Sinead Delany-Moretlwe, principal investigator for the trial…
WHO Solidarity Trial Consortium (2022).
Prof Helen Rees and Prof Thesla Palanee-Phillips were co–authors of an article published in The Lancet in May 2022 providing the final results of The WHO Solidarity trial. This trial was the world’s largest randomized control trial on COVID-19 therapeutics and was launched in 2020 during the pandemic to investigate…
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.…
IMPAACT 2035
This is a Phase I/II, double-blinded, placebo-controlled, randomized multi-center study to assess the safety and immunogenicity of VPM1002 vaccination and BCG revaccination among South African pre-adolescents who received BCG vaccine at birth. Rationale VPM1002 vaccination and BCG revaccination will be safe when administered to pre-adolescents who received BCG vaccine at…
CVIA 082 Study
A Phase II, Observer-blinded, Randomized, Active-controlled Study to Examine the Immunogenicity and Safety of Rotarix® and RV3-BB when Coadministered/Boosted with Trivalent P2-VP8 Subunit Rotavirus Vaccine Candidate in Healthy Infants in South Africa. Rationale Diarrhea is the second-leading cause of infectious disease death worldwide among children under the age of five.…
Horizon 2
A Randomized, Observer-blind, Phase 2/3 Adaptive Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive. Rationale This study will use young adults from VAC31518COV3001 and VAC31518COV3009 as external controls…
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…
SHERPA/SISONKE 4
Open-label, phase 3 study to evaluate the effectiveness of heterologous mRNA-1273 boosting of the single or two dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa. Rationale South Africa is severely affected by the global COVID-19 pandemic. As part of the Sisonke study, HCWs received a single dose…
IMPAACT 2019
Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age. Rationale A variety of methods will be used to evaluate adherence to daily administration of ABC/DTG/3TC in this study. For all children, questionnaires will be administered…
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)…
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. The consortium includes…
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…
MK 8591A-028
A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine/Islatravir in Adolescents with HIV-1 Infection who are Virologically Suppressed, are ≥12 to <18 Years of Age, and Weigh ≥35 kg. Rationale With anticipation of lifelong treatment, long term tolerability and safety of antiretrovirals have become increasingly…
Wits RHI PEPFAR COVID-19 Response
Wits RHI PEPFAR funded programmes (Tshwane CDC, Lejweleputswa APACE and Key Populations - USAID) in collaboration with PASP-ELMA, Project PrEP-UNITAID, and School-Based Programme - USAID) have established a PEPFAR RHI COVID-19 Response Committee which serves as a nerve centre to coordinate an internal Wits RHI COVID-19 response and to leverage…
HPV Vaccine Impact Evaluation Study
Impact of 2-dose and1-dose human papillomavirus (HPV) vaccination schedules on community level HPV prevalence in South African adolescent girls Primary Objectives Primary Objectives In South African adolescent girls aged 17–18 years; • To measure the population effectiveness of the national 2-dose vaccine schedule, delivered at age 9 years, in protecting…
MIP Longitudinal Study (OPPTIM)
The prevention of mother-to-child transmission of HIV (PMTCT) is the most successful HIV prevention intervention globally. In 2015 South Africa adopted the WHO’s “Option B+” PMTCT strategy: lifelong antiretroviral therapy (ART) for all HIV-positive pregnant and breastfeeding women, regardless of CD4 count. However the early effectiveness of PMTCT, especially in…
IMPAACT 2019
Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age Rationale To date, DTG has only been studied as a single ARV formulation in children. ABC/DTG/3TC (immediate release tablet marketed as Triumeq®) is a safe,…
PrEP SMART
PrEP SMART: Evaluation of stepped PrEP adherence support for young South African women. Purpose To test a stepped model of scalable adherence support strategies in South African young women who initiate PrEP, using a SMART design. Primary Objectives To evaluate: the proportion of young South African women who adhere well…
Dual Prevention Pill (DPP) for HIV and Pregnancy Prevention
A qualitative formative research study among women and health care providers in Johannesburg, South Africa. The DPP formative study will use focus group discussions and in-depth interviews to understand women’s interest in using a DPP for HIV and pregnancy prevention and gather inputs regarding informational materials needed for DPP introduction,…
Dual Prevention Pill (DPP) for HIV and Pregnancy Prevention
A qualitative formative research study among women and health care providers in Johannesburg, South Africa. The DPP formative study will use focus group discussions and in-depth interviews to understand women’s interest in using a DPP for HIV and pregnancy prevention and gather inputs regarding informational materials needed for DPP introduction,…
South African Population Research Infrastructure Network (SAPRIN)
South African Population Research Infrastructure Network A National Research Infrastructure of Health and Demographic Surveillance System (HDSS) Nodes Rationale Research in the human and social sciences is essential for social, economic and cultural development and transformation in South Africa. The overall aim is to reduce costs for government while making…
NVX2019nCOV501
Rationale The purpose of this study is 2-fold: 1) to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in serologically naïve (to SARS-CoV-2) healthy human immunodeficiency virus (HIV)-negative adult subjects (Cohort 1 – HIV-negative) and 2) to evaluate the safety and immunogenicity of SARS-CoV-2 rS with…
Novavax 2019nCOV501
A phase 2a/b, randomized, observer-blinded, placebo controlled study to evaluate the efficacy, immunogenicity, and safety of a sars-cov-2 recombinant spike protein nanoparticle vaccine (SARS-COV-2 RS) with matrix-m1™ adjuvant in South African adult subjects living without HIV; and safety and immunogenicity in adults living with HIV Rationale The purpose of this…
School Based HIV and GBV Prevention Programme
This program aims to reduce the incidence of HIV infection and violence adolescents. The technical approach utilizes the socio-ecological model in prioritized USAID provinces and districts (7 provinces and 14 districts) across the country working with schools and support staff (SBSTs, SMTs, SGBs, educators), parents, communities and health facilities to…
Hub and Spoke Planning Grant
Implementation Experiment to facilitate the creation of an appropriate and receptive environment for effective use of existing and new HIV prevention products to maximize their impact as they become available for AGYW in Gauteng province, South Africa. Rationale The HIV epidemic in South Africa has evolved from a state of…
FP‐PrEP
Feasibility of implementing an integrated hybrid model of service delivery for adolescent girls and young women (AGYW) sexual and reproductive health (SRH) in South Africa Summary AGYW in Sub Saharan Africa face a myriad of sexual and reproductive health challenges including HIV, sexually transmitted infections (STIs), intimate partner violence (IPV),…
African Leadership in Vaccinology Expertise (ALIVE)
The Wits African Leadership in Vaccinology Expertise (ALIVE) is a vaccinology flagship programme of the University of the Witwatersrand addressing the need for increasing vaccinology research capacity in the African region, and will offer new opportunities for authoritative global research leadership. ALIVE is a university-wide partnership of internationally recognised scientists…
ENBEL
ENhancing BELmont Research Action to support EU policy making on climate change and health (The ENBEL project) ENBEL aims to bring together leading researchers and policy groups in the EU and Africa who are working on climate change and health. The consortium intends to support EU climate change and health…
BCG Revax Gates MRI
Given its heavy burden of TB-associated disease and death, South Africa has a major interest in the development of an effective new TB vaccine. The only available vaccine, the Bacille Calmette-Guérin (BCG) vaccine, was developed 80 years ago. Several vaccine candidates are currently in the pipeline, and the M72/ASO1E candidate…
BaSiS Research Study
BaSiS is a research study to see whether a booster vaccine will improve the body’s immune responses in people who received the J&J vaccine through the SISONKE Phase IIIb implementation trial. Our researchers also want to know whether the time between SISONKE vaccination and a booster dose, HIV status, and…
V114‐030
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Children Infected with Human Immunodeficiency Virus (HIV) (PNEU–WAY PED) Rationale Human immunodeficiency virus (HIV) infection leads to defects in the humoral and…
Pfizer RSV Vaccine Study
A phase 3, randomized, double-or observer-blinded, placebo-controlled trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion f subunit vaccine in infants born to women vaccinated during pregnancy Rationale There is a large unmet medical need that could be addressed by an effective RSV prophylaxis in…
iPrEP‐STI
Integrating HIV Pre-exposure Prophylaxis and diagnostic STI care: An individualised public health approach (iPrEP-STI) Summary South Africa has some of the highest rates of sexually transmitted infections (STIs) and HIV globally. New STIs infections are increasing among South African adolescents where comprehensive and integrated quality of health services are limited.…
Coalition to Accelerate and Support Prevention Research (CASPR)
The purpose of this project is to support the development and sustainability of an Africa-centred network dedicated to advancing advocacy, policy, regulatory, community engagement and communications efforts that help accelerate biomedical HIV prevention research. The project began on 1 October 2016 with Partners’ Inception Meeting, and the project is now…
Care & Treatment Sub Award, Tshwane Health District
Despite all efforts to increase access to HIV prevention and ART in South Africa, incidence of HIV infection continues to be unacceptably high with an estimated 220 000 new infections per year. There is an urgent need to develop new interventions with a longer duration of action than the currently…
CHARISMA
Gender-based violence is widespread—as many as 1 in 3 women worldwide are subjected to some or multiple forms. Research to date suggests that male partner approval or active support is often desired, required, or culturally indicated for women’s microbicide use, although use is female initiated and designed to empower women…
GAP Year Study
Girls Achieve Power (GAP) Year: Building Health, Social and Educational Assets for Empowering Girls at Critical Time of Adolescent Transition GAP Year aims to To empower adolescent girls in the areas of health, education, social and economic assets while shifting gender attitudes and encouraging positive behaviour change among adolescent boys.…
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) Summary 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…
Virologic failure in South African Children
A description and comparison of four treatment modalities in children failing highly active antiretroviral therapy (HAART) in South Africa Rationale In practice it is difficult for the clinician to know what the optimal treatment is for children who are failing their HAART regimen, particularly if there are ongoing adherence problems,…
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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.