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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.

SAMURAI

GBS 6 Vaccine Study (C1091002)

A Phase 1/2 clinical trial has been designed as a randomised, placebo-controlled, observer-blinded study to assess the safety, tolerability, and immunogenicity of a multivalent group…

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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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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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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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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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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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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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Jansen ENSEMBLE VAC31518COV3001 HG

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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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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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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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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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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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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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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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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Maternal and parent child (MCH) refers to a field of healthcare that focuses on the well-being and care of both mothers and their children, encompassing the period from pregnancy to infancy and early childhood. This specialised branch of public health emphasizes promoting and ensuring the physical, mental, and emotional health of both mothers and children, recognizing their interconnectedness and the critical impact of early life experiences on lifelong health outcomes.

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