Our Projects

Wits RHI has been tackling Africa’s health challenges through science and innovation for over two decades, with an unparalleled track record of implementing sustainable programmes and contributing to health policy. This web page sets out to highlight the breadth and scope of our work and presents a brief overview of some of our 72 active projects during 2020.

While the projects may focus on the areas of sexual reproductive health and HIV, vaccine and infectious diseases, and other emerging issues, the projects cannot be compartmentalised as single-issue solutions. Intervention in one area, such as sexual and reproductive health, inevitably has a positive impact on another, such as HIV prevention.

Actively Recruiting Studies

We currently have a number of studies that are actively recruiting.

Research Centre, Shandukani CRS and Ward 21 CRS are looking for study participants to join their new and exciting COVID vaccine & antibody and HIV prevention studies.

List of Active Projects

Accelerating Program Achievements to Control the Epidemic, Lejweleputswa District
This programme leverages key innovations to ensure a comprehensive package of services that meets the wide-ranging needs of different patient groups across the HIV and TB continuum of care.

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 with a breadth of expertise across the discipline of vaccinology and over time will integrate both Wits and external scientists with an emerging interest in this field.

B-Wise Social Media: Supporting SA youth with HIV edutainment bursts

This initiative enables innovative solutions focusing on the HIV preven¬tion among vulnerable groups during the COVID-19 crisis.

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.

The purpose of this project is to evaluate the safety and tolerability of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, alone and in combination, intravenously (IV) or subcutaneously (SC) to HIV-uninfected adults.

Care & Treatment Sub Award, Tshwane Metropolitan Municipality
This programme aims to improve and expand comprehensive clinical and non-clinical differentiated HIV care and treatment services that will accelerate and sustain HIV epidemic control in South Africa and integrating the COVID-19 contextual requirements.

ChAdOx1 nCoV-19
An adaptive phase I/II randomized placebo-controlled trial to determine safety, immunogenicity and efficacy of non-replicating ChAdOx1 SARS-CoV-2 vaccine in South African adults living without HIV; and safety and immunogenicity in adults living with HIV.

This project aims to increase women’s agency to consistently and safely use microbicides and mitigate IPV through three specific objectives:
To identify improved approaches to measure and address the beneficial impacts and harmful social effects—particularly IPV—of microbicide use;
To develop and pilot test the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) intervention, which has clinic- and community-based components; and
To disseminate knowledge generated and promote uptake of promising practices for future microbicide and multipurpose prevention technology implementation projects

Coalition to Accelerate and Support Prevention Research (CASPR)
The purpose of this project is to support the development and sustainability of an Africa-centered network dedicated to advancing advocacy, policy, regulatory, community engagement and commun-ications efforts that help accelerate biomedical HIV prevention research.

COVID vaccine Implementation Science
A COVID-19 vaccine plan led by the Implementation Science team.

COVID-19 Sero Survey
A cross-sectional COVID-19 survey involving questionnaires and seroprevalence, with the aim of measuring and understanding COVID-19 perceptions and impacts among residents of Hillbrow.

The purpose of this project is to assess the effectiveness of the Measles and Rubella (MR) and Measles, Mumps and Rubella (MMR) vaccines in preventing COVID-19 disease in healthcare workers.

DAISY – Specific Aim 3
This project aims to measure acceptability of, and preferences for the DAISY drug delivery platform among two key end-user groups in South Africa (SA): caregivers of HIV-positive children receiving antiretroviral therapy (ART) and health care providers.
These end-user perspectives are linked to the Target Product Profile (TPP) and will inform design of the DAISY, including device and applicator characteristics.

DPP (Dual Prevention Pill) 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, assess DPP acceptability among providers and explore their training needs and recommendations for appropriate service-delivery settings. The study will also inform the implementation plan for the clinical crossover study (with the objective to assess the acceptability of a Dual Prevention Pill (DPP) containing an oral pre-exposure prophylaxis (PrEP) pill and a combined oral contraceptive (COC) pill in a single capsule for pregnancy and HIV prevention) among women.

The EDCTP-COREP COVID-19 Household Cluster Investigation
This study aims to determine the epidemiological parameters of COVID-19 through a household transmission study in a rural area of South Africa.

ELMA “Unfinished Business” Project
This project, led by Wits RHI (as an implementing partner) in the City of Tshwane, aims to increase 90-90-90 outcomes in children and adolescents including the following activities: case-finding for HIV, TB screening, linkage to HIV care, ART initiation, retention in care and viral suppression in the City Tshwane

This project aims to explore the 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

GBS EPI Study (1091006)
This study is being conducted within the setting of tertiary and secondary hospitals and their referring antenatal clinics and midwife obstetric units (MOU) in which the Phase I/II GBS clinical trial takes place. The aim is to estimate the incidence of obstetric and perinatal birth outcomes in a population as similar as possible to the population included in the Phase I/II trial. The data generated from this study will enable contextualization of emergent safety signals.

GBS6 Vaccine Study (C109-1002)
This Study is a phase 1/2, randomized, placebo-controlled, observer-blinded Trial to evaluate the safety, tolerability, and immunogenicity of a multivalent group b streptococcus vaccine in healthy non pregnant women and pregnant women 18 to 40 years of age and their infants.

Girls Achieve Power (GAP) Year Study
This program aims 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. Utilizing an ecological model, GAP Year will work with schools, communities, parents, NGOs and health care facilities to encourage a culture of health and safety. Importantly we will also build the evidence base around the impact of asset-building approaches for adolescents

The Health Care Worker Health and Wellbeing Study

This study focuses on health and mental wellbeing of health workers providing care to patients with COVID-19 in Johannesburg, South Afri¬ca: rapid needs assessment and action research.

Health Systems Strengthening Overview
This project aims to strengthen health systems for better HIV/TB patient outcomes.

HPTN 084 (The Life Study)
The purpose of this project is to evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.

HPTN 084-01
The purpose of this project is to evaluate the Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Females – A Sub-study of HPTN 084

HPTN084 CoVPN Preparedness Fund

To provide support to Ward 21 CRS #31966, to strengthen their site capacity to participate in large Phase 111 efficacy trials.

HPV One and Two Dose Population Effectiveness Study (HOPE)
The purpose of this project is to monitor the effectiveness of a 2-dose and 1-dose HPV vaccination schedules on community-level HPV prevalence among South African adolescent girls

HPV Vaccine Impact Evaluation Study
The purpose of this project is to monitor the effectiveness of a 2-dose and 1-dose HPV vaccination schedules on community-level HPV prevalence among South African adolescent girls.

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

Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081
We are looking at the effect previous exposure to monoclonal antibodies and rapid ARV introduction will have on subsequent ability to suppress HIV viral load. This study is a follow on from the AMP study which was a proof of concept study in using monoclonal antibodies to prevent HIV acquisition.

Integrating PrEP into Comprehensive Services for Adolescent Girls and Young Women
The project leverages off She Conquers and focuses on effective coordination and collaboration across the different channels (households/community structures, schools, technical and vocational education training (TVETs), public health facilities, and outreach services) informed by mapping of partners and services in the selected sub-districts.
To facilitate large scale PrEP access by AGYW, a range of demand creation campaigns and messaging for different target audiences (AGYW in schools, rural versus urban settings, in tertiary education, in employment and unemployed) have been designed, implemented, and monitored.

Integrating HIV Pre-exposure Prophylaxis and diagnostic STI care: An individualised public health approach (iPrEP-STI). The aim of this study is to engage policy makers, healthcare providers and patients in discrete choice experiments to establish preferences for diagnosis and treatment of STIs and assess the feasibility of integrating these within the South African health-system.

Jansen ENSEMBLE VAC31518COV3001 HG
This project aims to demonstrate the efficacy of AD26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to Placebo, in SARS-CoV-2 Seronegative adults.

MIP Longitudinal Study (OPPTIM)
This project aims to compare viral load suppression rates (viral load<1000 copies/ml) between HIV-positive postpartum women on first line ART, receiving a package of enhanced viral load monitoring with viral load point of care testing to those receiving standard of care lab-based viral load monitoring

MSD V114
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).

A Phase 3B, Randomized, Open-Label, Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA ® in Breastfeeding Mother-Infant Pairs.

National testing and contact tracing across our PEPFAR-funded programmes: The Wits RHI PEPFAR COVID-19 Response committee
The committee serves as a nerve centre to coordinate the internal Wits RHI COVID-19 response and to leverage resources and best prac¬tices between the programmes. This committee response is guided by the Wits RHI Steering committee, PEPFAR and its agencies (USAID, CDC, UNITAID, and ELMA).

Novovax 2019nCOV501
This project aims to assess 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

An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials
This study aims to compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.

The purpose of this project is to test a stepped model of scalable adherence support strategies in South African young women who initiate PrEP, using a SMART design.

PROMISE (Preparing for Ring Opportunities through Market Introduction Support and knowledge Exchange)
This program aims 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.

SAMURAI (South African Male User Research on Acceptability of Implants and Injections) for HIV prevention
A qualitative formative research study among heterosexual men (men who have sex with women) and men-who-have-sex-with-men (MSM) in South Africa. SAMURAI is a three Aim study to assess acceptability of, and preferences for, novel long-acting pre-exposure prophylaxis delivery formulation (implant and injectable) use among key end-users. The formative study will use in-depth interviews to explore heterosexual men and MSM’s knowledge, attitudes, and perceptions of implants and injectables and their use for HIV prevention. This study will also examine anticipated benefits and challenges to clinical delivery of these products to men, study implementation concerns, and strategies to address male engagement with the research clinic for Aims 2 and 3 (a clinical research study and a discrete-choice survey).

School Based HIV and GBV Prevention Programme
This program aims to reduce the incidence of HIV infection and violence among 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 ensure access and linkage to quality care, youth-friendly health service provision for adolescents. Services offered are aligned to the Integrated School Health Programme (ISHP) and the National Department of Health (NDOH) scale-up plan for Pre-Exposure Prophylaxis (PrEP).

Sex Workers and Male Clients
This project aims to support the South African Government to develop, implement, and evaluate a National Sex Worker and Male Client Plan through the provision of

A multi-centre, randomized, open-label, noninferiority trial to evaluate the efficacy and safety of a single, oral dose of zoliflodacin compared to a Combination of a single intramuscular dose of Ceftriaxone and a single oral dose of azithromycin in the Treatment of patients with uncomplicated gonorrhoea

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)

UNITY Healthcare Worker Registry
The purpose of this project is to assess the association of potential prophylactic treatments with reduced risk of COVID-19 (or SARS-CoV-2 infection) in HCWs caring for COVID-19 patients

Virologic failure in South African Children
This project aims to explore the description and comparison of four treatment modalities in children failing highly active antiretroviral therapy (HAART) in South Africa

Wits RHI Key Populations Programme
This programme aims to provide HIV testing and counselling services (HTC), prevention technologies including oral pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), treatment of sexually transmitted infections (STIs), tuberculosis (TB) screening, sexual and reproductive health services, chronic disease management and treatment of minor ailments, to Sex Workers and Transgender individuals.

HIV Self-Testing (Aids Fonds)
The aim of the study is to assess the impact of variation in wording and frequency of SMS messaging on contact with and linkage to care after a HIVST. The primary hypothesis is that participants receiving more frequent, behaviourally optimised SMS messages will be more likely to report test use and test result. We do not hypothesise any difference in responses across study arms for revelation of a positive test, or in choices for the type of test used.

HSTAR - HIV Self-Testing Assessments and Research (Gates Study)
This project aims to bring high quality, WHO-approved HIV self-tests to commercial market in South Africa

Low-dose Darunavir (DRV) Non-inferior to Lopinavir?
The primary objective of this study was to assess the non-inferiority of DRV/r 400mg/100mg daily when compared with LPV/r total dose 800mg/200mg per day in combination with a nucleoside backbone, as determined by the proportion of participants on each regimen with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 48.

The OPTIMIZE project is lead by a global consortium that aims to ensure the optimization of antiretroviral treatment (ART) that people living with HIV receive. making sure these are the best-available ART in the most efficient and cost-effective manner possible.

STAR – Self-Testing Africa Initiative (UNITAID funded)
This project aims to support the NDoH in rolling out HIVSS in South Africa to increasie HIV testing especially amongst under-tested, undiagnosed, and test-averse people living in South Africa

The ADVANCE trial intends to demonstrate the non-inferiority of DTG/TAF/FTC when compared with DTG/TDF/FTC or EFV/TDF/FTC in first-line HIV treatment of patients ≥12 years old. The trial will take place at 2-3 sites in South Africa.