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Infectious Diseases
Sexual and Reproductive Health

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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Infectious Diseases
Sexual and Reproductive Health

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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Infectious Diseases
Vaccine Preventable Diseases

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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Infectious Diseases

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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Infectious Diseases
Sexual and Reproductive Health

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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Infectious Diseases
Vaccine Preventable Diseases

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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Infectious Diseases
Sexual and Reproductive Health

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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Infectious Diseases

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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Infectious Diseases

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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Infectious Diseases
Vaccine Preventable Diseases

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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Infectious Diseases
Vaccine Preventable Diseases

DAISY – Specific Aim 3

Delivery of Antiretrovirals via Implantable System for Young Children (DAISY) Specific Aim 3. Rationale South Africa reports one of the highest populations of HIV-infected young children and of the 55% of children that receive ART only 67% are virally suppressed. Adherence and retention in care are affected by multiple challenges…

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Infectious Diseases
Vaccine Preventable Diseases

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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Infectious Diseases

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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Infectious Diseases

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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Infectious Diseases

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…

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Infectious Diseases

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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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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Infectious Diseases
Vaccine Preventable Diseases

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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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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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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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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