Wits RHI
Current projects
Current projects
Beatrix Study (C1091009)
Advancing maternal and infant health through a Phase 3 clinical trial evaluating a Group B Streptococcus (GBS) vaccine in pregnancy. This study aims to improve newborn protection by assessing vaccine safety, tolerability, and immune response in mothers and their infants.
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HOPE II Study
Efficacy of single-dose nonavalent Human Papillomavirus (HPV) Vaccination boost to prevent incident persistent HPV 16/18/31/33/45/52/58 infection among women living with HIV who were previously vaccinated against HPV 16/18.
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M72 TB Vaccine Trial (Gates MRI-TBV02-301)
Advancing the fight against tuberculosis
Wits RHI is part of a global Phase 3 clinical trial evaluating the M72/AS01E vaccine, a promising candidate to help prevent tuberculosis (TB) in adolescents and adults.Building on earlier results showing ~50% protection against TB disease, this study aims to confirm effectiveness and support the development of a new, impactful TB vaccine. Lead Investigator: Prof Lee Fairlie.
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Project PrEP
Project PrEP is a Unitaid-funded implementation science 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 fixed and mobile service platforms in Tshwane, Mthatha, Gqeberha, and eThekwini, South Africa. The project uses a cluster model comprising primary healthcare facilities and mobile clinics to improve geographic and service accessibility for AGYW in high-priority communities.
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HPTN 108/ PAUSE STUDY
A Phase I, Randomized, Placebo-Controlled Study of the Safety, Antiviral & Immunomodulatory Activity of Broadly Neutralizing Antibodies 3BNC117-LS-J and 10-1074-LS-J in Combination in ART-treated Adults in sub-Saharan Africa Living with HIV during a Monitored Analytical Treatment Interruption.
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Project PrEP
Project PrEP: Integrating PrEP Choice into comprehensive sexual and reproductive health services in South Africa, while expanding equitable access to and affordability of long-acting HIV prevention for the region. Rationale Project PrEP is a Unitaid-funded implementation science initiative that began in 2018, aimed at integrating oral PrEP into comprehensive sexual…
BEATRIX Study (C1091009)
Project Title Beatrix Study (C1091009): Maternal Vaccine to Prevent Group B Streptococcus in Infants Overview The Beatrix Study is a Phase 3 clinical trial evaluating the safety, tolerability, and immune response of a Group B Streptococcus (GBS) vaccine (GBS6) administered during pregnancy. The study aims to determine whether vaccinating pregnant…
M72 TB Vaccine Study (Gates MRI-TBV02-301)
Project Title Gates MRI-TBV02-301 (M72): Phase 3 Tuberculosis Vaccine Trial Overview The Gates MRI-TBV02-301 (M72) study is a large-scale Phase 3 clinical trial evaluating the efficacy, safety, and immune response of the investigational M72/AS01E tuberculosis (TB) vaccine in adolescents and adults. The study aims to determine whether this vaccine can…
IMPAACT 2036 CRAYON Study
Project Title IMPAACT 2036 (CRAYON Study): Long-Acting HIV Treatment in Children Overview IMPAACT 2036 (CRAYON) is a Phase I/II clinical study evaluating the safety, tolerability, acceptability, and pharmacokinetics of oral and long-acting injectable Cabotegravir (CAB) and Rilpivirine (RPV) in children living with HIV-1. The study focuses on children aged 2…
M1439-066
Project Title KK-1439-066: A Phase 2 Clinical Study of Doravirine-Based Treatment in Children Living with HIV-1 Overview This Phase 2 clinical study evaluates the pharmacokinetics (PK), safety, tolerability, and efficacy of Doravirine (DOR), administered either in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) or as a fixed-dose combination (DOR/3TC/TDF),…
SHIELD Study
Project Title SHIELD Study: Advancing Treatment Options for Children and Adolescents with Drug-Resistant HIV Overview The SHIELD Study is a Phase I/II clinical trial evaluating the safety, pharmacokinetics, and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in children and adolescents living with HIV-1. The study focuses…
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,…
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…
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…
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…
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 2009
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…
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…
PURPOSE 2 Study
A Phase 3 Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Long-Acting Subcutaneous Lenacapavir and Daily Oral Emtricitabine/Tenofovir Alafenamide for HIV Prevention. Rationale Daily oral PrEP options such as F/TDF (Truvada) and F/TAF (Descovy) are highly effective in preventing HIV infection. However, adherence to a daily pill remains a…
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…
PURPOSE 1 Study
A Phase 3, Randomized, Double-Blind Study Evaluating Long-Acting Subcutaneous Lenacapavir and Oral Emtricitabine/Tenofovir Alafenamide for HIV Prevention in Adolescent Girls and Young Women. Rationale Although daily oral PrEP options like F/TDF have demonstrated high efficacy and are recommended for HIV prevention among women, adherence challenges especially among adolescent girls and…
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…
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…
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%,…
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 and…
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…
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,…
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…
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…
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…
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…
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…
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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.