Wits RHI
Current projects
Current projects
HOPE II Study
The Human Papillomavirus One-Dose-vaccine Prevention Efficacy among Women Living with HIV (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 women who had previously received an HPV 16/18 vaccination before their HIV diagnosis.
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IMPAACT 2028
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 goals of IMPAACT 2028 are to establish long-term follow-up of participants who received early treatment for future interventional cure and/or remission trials and to establish a unique biorepository from which additional scientific questions can be answered.
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HIGH Horizons: Heat Indicators for Global Health
The HIGH Horizons Study is designed to address critical knowledge gaps regarding the direct and indirect effects of heat exposure on maternal, newborn, and child health. As climate change exacerbates heat risks, pregnant women, infants, and healthcare workers are identified as particularly vulnerable. The study aims to quantify and monitor these impacts, developing strategies to protect these populations
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BIYELA STUDY
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) prevention, with the primary goal of determining whether the Bexsero vaccine can effectively prevent cervical and/or anorectal gonococcal infections.
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M72 TB Vaccine Study (Gates MRI-TBV02-301)
This is Phase 3, randomized, double-blind, placebo-controlled, multicentre clinical trial evaluating the efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine. The study focuses on preventing tuberculosis (TB) in adolescents and adults aged 15 to 44 years
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M72 TB Vaccine Study (Gates MRI-TBV02-301)
This is a Phase 3, randomized, double-blind, placebo-controlled, multicentre clinical trial evaluating the efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine. The study focuses on preventing tuberculosis (TB) in adolescents and adults aged 15 to 44 years. Study Rationale Tuberculosis (TB) remains a significant global public…
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…
WONDERS 2 Study
WONDERS 2 Study: Exploring a Once-Weekly HIV Treatment Option The WONDERS 2 Study is a Phase 2/3 clinical trial being conducted by Wits RHI to assess the safety and efficacy of a novel once-weekly oral HIV-1 treatment regimen in people who have never received antiretroviral therapy (ART). The study evaluates…
HPTN 104 – Dual Prevention Pill (DPP) Study
HPTN 104 Study, a Phase 2b, open-label, multisite trial comparing adherence to a single daily Dual Prevention Pill (DPP) versus a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention (separately administered PrEP and COC) in people of childbearing potential without HIV. Study Details: Objective: Assess adherence to DPP…
MVX008 Study
The MVX008 Study is a Phase 3 follow-up trial assessing the long-term immunogenicity of the Group B Streptococcus (GBS) vaccine (GBS NN/NN2) previously administered to pregnant women between 21–24 weeks gestation. The Wits RHI site is participating in the HIV-negative cohort of the study. This study will also offer a…
IMPAACT 2040 (CREATE Study)
IMPAACT 2040, also known as the CREATE Study, is a Phase I/II clinical trial evaluating the pharmacokinetics and safety of long-acting injectable cabotegravir (CAB LA) and rilpivirine (RPV LA) in pregnant and postpartum women living with HIV-1. The study aims to support the development of long-acting antiretroviral therapy (ART) options…
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…
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,…
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…
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…
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…
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…
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). Overview The Coalition to Accelerate and Support Prevention Research (CASPR) is an Africa-centered initiative aimed at advancing biomedical HIV prevention research through advocacy, policy engagement, research preparedness, and community engagement. This project fosters collaboration among stakeholders to drive innovative, ethical, and effective…
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…
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/B-Protected Study
MTN 043/B-PROTECTED Study: 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…
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…
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 Study
The South African Male User Research on Acceptability of Implants and Injections (SAMURAI) Study. Rationale Previous research in Cape Town, South Africa, has shown a strong interest among young people, both men and women in using long-acting injectable and implantable HIV prevention products. Findings from the iPrevent Discrete Choice Experiment…
MESA-TB Gates MRI
MESA-TB Gates MRI : A Randomized, Placebo-Controlled, Observer-Blind, Phase 2 Study to Evaluate the Safety and Immunogenicity of the Investigational M72/AS01E Mycobacterium tuberculosis (Mtb) Vaccine in Virally Suppressed, Antiretroviral-Treated Participants with Human Immunodeficiency Virus (HIV). Rationale Previous phase 1 and 2 randomized controlled trials have demonstrated that the M72/AS01E vaccine is…
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…
MK8527-007 Study
Short Title: Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection. The MK8527-007 Study is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. The study is evaluating the safety, tolerability, and pharmacokinetics of oral MK-8527, administered once monthly, in adults aged 18…
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…
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,…
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…
MTN 042 – Deliver Study
MTN 042 – Deliver 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…
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…
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 Training Program
Rationale South Africa continues to face a significant HIV burden, despite progress in expanding antiretroviral therapy (ART), Pre-Exposure Prophylaxis (PrEP), and reducing HIV incidence and mortality. Achieving the UNAIDS 95-95-95 targets requires overcoming persistent barriers to the effective implementation of HIV prevention and care programs. Implementation Science (IS) offers a…
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…
GSK205858 Study
GSK205858 Study: Continued Access to Etravirine in Treatment-Experienced HIV-1 Infected Individuals. The GSK205858 Study is a non-randomized, open-label, multi-center rollover study designed to provide continued access to investigational products (IP) for treatment-experienced HIV-1 infected pediatric participants who previously took part in parent studies P1093 or P2019. Rationale The aim of…
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…
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…
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…
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…
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…
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…
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,…
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…
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.…
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…
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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.