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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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.…
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…
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…
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…
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)…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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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.