Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

Abstract A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the Wor...

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Autores principales:	Maurine D. Miner, Linda-Gail Bekker, Tamara Kredo, Niresh Bhagwandin, Lawrence Corey, Glenda E. Gray
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Pre-exposure prophylaxis South Africa Standard of care LMIC HIV/AIDS Clinical trials Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/70337065fbfe4ace9e7380ae1bb80fcd
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spelling	oai:doaj.org-article:70337065fbfe4ace9e7380ae1bb80fcd2021-11-08T11:03:06ZMeeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 201710.1186/s13063-021-05754-z1745-6215https://doaj.org/article/70337065fbfe4ace9e7380ae1bb80fcd2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05754-zhttps://doaj.org/toc/1745-6215Abstract A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials.Maurine D. MinerLinda-Gail BekkerTamara KredoNiresh BhagwandinLawrence CoreyGlenda E. GrayBMCarticlePre-exposure prophylaxisSouth AfricaStandard of careLMICHIV/AIDSClinical trialsMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Pre-exposure prophylaxis South Africa Standard of care LMIC HIV/AIDS Clinical trials Medicine (General) R5-920
spellingShingle	Pre-exposure prophylaxis South Africa Standard of care LMIC HIV/AIDS Clinical trials Medicine (General) R5-920 Maurine D. Miner Linda-Gail Bekker Tamara Kredo Niresh Bhagwandin Lawrence Corey Glenda E. Gray Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
description	Abstract A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials.
format	article
author	Maurine D. Miner Linda-Gail Bekker Tamara Kredo Niresh Bhagwandin Lawrence Corey Glenda E. Gray
author_facet	Maurine D. Miner Linda-Gail Bekker Tamara Kredo Niresh Bhagwandin Lawrence Corey Glenda E. Gray
author_sort	Maurine D. Miner
title	Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
title_short	Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
title_full	Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
title_fullStr	Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
title_full_unstemmed	Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
title_sort	meeting report: south african medical research council standard of care in clinical research in low- and middle-income settings summit, november 2017
publisher	BMC
publishDate	2021
url	https://doaj.org/article/70337065fbfe4ace9e7380ae1bb80fcd
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Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

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