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Zoliflodacin Trial

A multi-center, 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. Rationale There is growing concerns…

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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…

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PrEP SMART

Evaluation of stepped PrEP adherence support for young South African women using a SMART design. Rationale To evaluate the proportion of young South African women who adhere well to PrEP with regular clinic visits and mHealth interventions alone, the proportion of women who adhere well to PrEP with intensified interventions…

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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…

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TMC125-TiDP35

Continued access to etravirine in treatment experienced HIV-1 infected subjects. Rationale The aim of the study is to provide continuous access to ETR for subjects who have completed a clinical study with ETR sponsored by or in collaboration with Janssen Research & Development.  Primary Objectives The primary objective is to…

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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…

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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…

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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…

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VXA-NVV-108 (VAXART)

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 breast-feeding infants. Rationale Noroviruses (NoVs) are a diverse group of small RNA viruses that cause…

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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 specific aims: Advocacy: Foster a knowledgeable and influential…

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Accelerating Program Achievements to Control the Epidemic (APACE)

Accelerating Program Achievements to Control the Epidemic (APACE). Rationale South Africa is at the forefront of the global AIDS response. Although the country has the world’s largest HIV treatment programme, challenges remain in preventing new infections and reducing morbidity and mortality. In 2017, South Africa’s burden of HIV infection was…

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INSIGHT Study

A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women. Study Objectives Estimate HIV incidence using the recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort. Assess the characteristics of women who…

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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…

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PURPOSE 2

A phase 3, double-blinded, multicentre, randomised study to evaluate the safety and efficacy of twice yearly long-acting subcutaneous Lenacapavir, and daily oral Emtricitabine/Tenofovir Alafenamide for pre-exposure prophylaxis in cisgender men, transgender women, transgender women, transgender men and gender non-binary at risk of HIV infection. Rationale Both daily oral emtricitabine/tenofovir disoproxil…

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IMPOWER – 022

A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection. Study Primary Objectives To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the prevention of HIV-1…

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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…

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CoVPN 3008 Ubuntu

Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Primary Objectives to assess the relative risk of symptomatic COVID-19 in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) who receive a 2-dose mRNA-1273 vaccine regimen vs. in Group 2 (PLWH who are SARS-CoV-2…

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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%,…

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IAVI C100 Study

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117- LS-J and 10-1074- LS-J, in Healthy American and African Adults (IAVI C100). Rationale 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…

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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…

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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 of alternative…

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HVTN 805/HPTN 093

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. Rationale Antiretroviral therapy (ART) has greatly improved the health and quality of life for many people with HIV by suppressing…

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PURPOSE 1

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 effective for PrEP…

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The CATALYST Study

Catalysing Access to New HIV Prevention Products to Stop HIV (CATALYST) Rationale The CATALYST implementation science study, part of the MOSAIC Project, spans several sub-Saharan African countries (South Africa, Lesotho, Kenya, Zimbabwe, and Uganda). It aims to empower women in these regions to prevent HIV by accelerating the adoption and…

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HVTN 140/HPTN 101

A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV uninfected adult participants. Rationale The HVTN 140/HPTN 101 study wants to understand how the body’s immune system responds to a new lab-made antibody against…

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Crown Coronation

An international, Bayesian platform adaptive, randomized, placebo‐controlled trial assessing the effectiveness of candidate interventions in preventing COVID‐19 disease in adults Primary Objectives To determine the effectiveness of MR (or MMR) vaccine in preventing symptomatic (i.e. any of the following: cough, shortness of breath or difficulty breathing, fever, chills, muscle pain,…

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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…

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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…

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IMPAACT 2010

Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants.  Rationale To compare the virologic efficacy and safety of three antiretroviral regimens for HIV-1-infected pregnant women and to compare the safety of these regimens for their infants.  Primary…

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HPTN 084-01

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Females – A Sub-study of HPTN 084. Rationale Despite reductions in other age groups, the number of deaths attributable to HIV is rising in the adolescent age group. As with many daily medication regimens,…

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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…

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UBOMI BUHLE

Understating Birth outcomes from mothers and infants, building healthcare by linking exposures South African Pregnancy Exposure Registry. Rationale With the rollout of the new adult and PMTCT treatment guidelines, which include the introduction of dolutegravir (DTG)-based antiretroviral therapy (ART) as first-line HIV treatment in South Africa, the South African National…

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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. Rationale The COVID-19 pandemic has significantly disrupted healthcare systems and economies worldwide. Despite efforts, the virus…

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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…

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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…

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DREAMS PrEP Choice Study

Rationale Long-acting products have the potential to prevent HIV acquisition without relying on adherence to a daily oral regimen. The development of alternative PrEP products such as the PrEP ring and CAB-LA have expanded alternative biomedical HIV prevention options to increase access to most at-risk individuals. It is important to…

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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…

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IMPAACT 2017

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 is a Phase I/II study being conducted to establish if adolescents (and later younger children), infected with HIV-1 who…

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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…

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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,…

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NGG-001

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…

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HOPE (HPV One and two dose Population Effectiveness) Study

Impact of 2-dose and 1-dose human papillomavirus (HPV) vaccination schedules on community level HPV prevalence in South African adolescent girls. To monitor the effectiveness of a 2-dose and 1-dose HPV vaccination schedules on community level HPV prevalence among South African adolescent girls. Primary Outcomes In South African adolescent girls aged…

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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…

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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…

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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). Rationale In South Africa (SA), adolescent girls and young women (AGYW) face significant rates of new HIV infections. HIV pre-exposure…

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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…

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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 escalating globally, particularly in South Africa, where they rank among the highest worldwide. Concurrently, South Africa faces the highest HIV-1 incidence globally, notably among…

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GILEAD

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. Rationale The success of HAART and the apparent benefits of maximally suppressed viremia have shifted clinical attention towards ARV agents that optimize long-term…

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 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…

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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…

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MTN 042

MTN-042 is a Phase 3B, randomized, open-label safety and pharmacokinetic trial focusing on the use of the Dapivirine Vaginal Ring (VR) and Oral FTC/TDF during pregnancy. Rationale This multicenter, prospective study aims to assess the safety, adherence, and acceptability of the DPV VR (25 mg) inserted every 4 weeks, along…

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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…

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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…

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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…

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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.…

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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…

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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…

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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…

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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…

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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…

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 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…

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MESA-TB Gates MRI

A randomized, placebo-controlled, observer-blind, phase 2 study to evaluate safety and immunogenicity of the investigational M72/AS01E Mycobacterium tuberculosis (Mtb) vaccine in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus (HIV). Rationale Published phase 1 and 2 randomized, controlled trials evaluating M72/AS01E vaccination in individuals with HIV who were receiving antiretroviral…

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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.…

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Jansen ENSEMBLE: VAC31518COV3001

A Randomized , Double -Blinded, Placebo-Controlled Phase 3 Study to assess the Efficacy and safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older. Rationale The development of a vaccine for Coronavirus disease -19 (COVID-19) will be critical for containing the current outbreak and…

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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…

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The HIV Prevention Trials Network

The ECHO Study is designed to assess three highly effective, reversible long-acting contraceptive methods: the progestogen-only contraceptive depot medroxyprogesterone acetate (DMPA), the Jadelle sub-dermal implant and the copper intrauterine device (IUD) among sexually active HIV-negative women ages 16 to 35. https://www.hptn.org/

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ECHO Study

The ECHO Study is designed to assess three highly effective, reversible long-acting contraceptive methods: the progestogen-only contraceptive depot medroxyprogesterone acetate (DMPA), the Jadelle sub-dermal implant and the copper intrauterine device (IUD) among sexually active HIV-negative women ages 16 to 35. http://echo-consortium.com/

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AVIWE

The AVIWE programme provides technical assistance at national and provincial levels to strengthen and standardise multi-sectoral programming for improved HIV prevention, care and treatment outcomes for adolescent girls and young women (AGYW). Click here to download An evaluation of the AVIWE Technical Assistance Grant on Improving HIV care, treatment and…

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The Adolescent Innovations Project

Wits RHI’s USAID-funded Adolescent Innovations Project (AIP), in collaboration with the Department of Health, developed, implemented and evaluated an integrated model of care focused on achieving the UNAIDS 90-90-90 targets for adolescents and young people ages 10-24 years.

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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. This grant will run over five years. Gophelega is at the heart of…

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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…

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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…

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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…

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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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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…

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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…

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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.…

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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…

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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.…

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 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…

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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…

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IMPAACT 2036 CRAYON Study

Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1,Two to Less Than 12 Years of Age. Rationale This study will use a mixed-methods approach to gather participant experience data that includes brief staff-collected questionnaires…

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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…

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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…

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 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)…

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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. The consortium includes…

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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…

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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…

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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…

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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…

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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…

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MESA‐TB Gates MRI

A randomized, placebo-controlled, observer-blind, phase 2 study to evaluate safety and immunogenicity of the investigational M72/AS01E Mycobacterium tuberculosis (Mtb) vaccine in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus (HIV) p> Rationale Published phase 1 and 2 randomized, controlled trials evaluating M72/AS01E vaccination in individuals with HIV who were receiving…

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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,…

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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…

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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,…

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

Bwisehealth.com is a mobi-site which provides health at your fingertips. B-Wise is an award-winning product of South Africa’s National Department of Health in partnership with PEPFAR to promote health among adolescents and young people in South Africa. https://www.bwisehealth.com/   This initiative enables innovative solutions focusing on the HIV prevention among…

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Accelerating Program Achievements to Control the Epidemic (APACE)

Primary Objective Wits RHI and USAID entered a partnership that will result in accelerated efforts to control the HIV epidemic in South Africa. Wits RHI will work closely with the Department of Health and other key stakeholders to manage the “Accelerating Program Achievements to Control the Epidemic (APACE)” in the…

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APACE, 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. Wits RHI and USAID entered a partnership that will result in accelerated efforts to control the HIV epidemic in South Africa.…

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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,…

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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…

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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…

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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 Rationele The purpose of this…

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Wits RHI Key Populations Programme

During the first year of the 5-year USAID Award for advancing the South African HIV Response for Key Populations, Sex Workers, and Transgender individuals, the Wits RHI Key Populations intensified services at 4 existing sex worker sites and opened 4 new transgender sites. The latter provide the first USAID-funded services…

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APACE – Accelerating Program Achievements to Control the Epidemic

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…

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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…

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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…

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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),…

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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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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…

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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…

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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…

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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…

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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…

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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.…

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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…

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OPTIMIZE/ADVANCE

OPTIMIZE – a global partnership to accelerate access to simpler, safer and more affordable HIV treatment – harnesses the expertise of a diverse group of partners to fast-track the introduction of improved antiretroviral (ARV) drugs and formulations in low- and middle-income countries (LMICs). The Joint United Nations Programme on HIV/AIDS…

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IMPAACT 2017

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 is a Phase I/II study being conducted to establish if adolescents (and later younger children), infected with HIV-1 who…

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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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STAR – Self‐Testing Africa Initiative

This project aims to support the NDoH in rolling out HIVSS in South Africa to increase HIV testing especially amongst under-tested, undiagnosed, and test-averse people living in South Africa Visit https://www.ezintsha.org/

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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…

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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.…

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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…

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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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