Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
| dc.contributor.author | Miner, Maurine D | |
| dc.contributor.author | Bekker, Linda-Gail | |
| dc.contributor.author | Kredo, Tamara | |
| dc.contributor.author | Bhagwandin, Niresh | |
| dc.contributor.author | Corey, Lawrence | |
| dc.contributor.author | Gray, Glenda E | |
| dc.date.accessioned | 2021-11-22T08:43:28Z | |
| dc.date.available | 2021-11-22T08:43:28Z | |
| dc.date.issued | 2021-11-06 | |
| dc.date.updated | 2021-11-07T04:14:08Z | |
| dc.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. | en_US |
| dc.identifier.apacitation | Miner, M. D., Bekker, L., Kredo, T., Bhagwandin, N., Corey, L., & Gray, G. E. (2021). Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017. <i>Trials</i>, 22(1), 778. http://hdl.handle.net/11427/35329 | en_ZA |
| dc.identifier.chicagocitation | Miner, Maurine D, Linda-Gail Bekker, Tamara Kredo, Niresh Bhagwandin, Lawrence Corey, and 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." <i>Trials</i> 22, 1. (2021): 778. http://hdl.handle.net/11427/35329 | en_ZA |
| dc.identifier.citation | Miner, M.D., Bekker, L., Kredo, T., Bhagwandin, N., Corey, L. & Gray, G.E. 2021. Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017. <i>Trials.</i> 22(1):778. http://hdl.handle.net/11427/35329 | en_ZA |
| dc.identifier.ris | TY - Journal Article AU - Miner, Maurine D AU - Bekker, Linda-Gail AU - Kredo, Tamara AU - Bhagwandin, Niresh AU - Corey, Lawrence AU - Gray, Glenda E AB - 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. DA - 2021-11-06 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - Trials KW - Pre-exposure prophylaxis KW - South Africa KW - Standard of care KW - LMIC KW - HIV/AIDS KW - Clinical trials LK - https://open.uct.ac.za PY - 2021 T1 - Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017 TI - Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017 UR - http://hdl.handle.net/11427/35329 ER - | en_ZA |
| dc.identifier.uri | https://doi.org/10.1186/s13063-021-05754-z | |
| dc.identifier.uri | http://hdl.handle.net/11427/35329 | |
| dc.identifier.vancouvercitation | Miner MD, Bekker L, Kredo T, Bhagwandin N, Corey L, Gray GE. Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017. Trials. 2021;22(1):778. http://hdl.handle.net/11427/35329. | en_ZA |
| dc.language.iso | en | en_US |
| dc.language.rfc3066 | en | |
| dc.publisher.department | Desmond Tutu HIV Centre | en_US |
| dc.publisher.faculty | Faculty of Health Sciences | en_US |
| dc.rights.holder | The Author(s) | |
| dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_US |
| dc.source | Trials | en_US |
| dc.source.journalissue | 1 | en_US |
| dc.source.journalvolume | 22 | en_US |
| dc.source.pagination | 778 | en_US |
| dc.source.uri | https://trialsjournal.biomedcentral.com/ | |
| dc.subject | Pre-exposure prophylaxis | en_US |
| dc.subject | South Africa | en_US |
| dc.subject | Standard of care | en_US |
| dc.subject | LMIC | en_US |
| dc.subject | HIV/AIDS | en_US |
| dc.subject | Clinical trials | en_US |
| dc.title | Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017 | en_US |
| dc.type | Journal Article | en_US |