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

AbstractA 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.

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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

10.14293/111.000/000010.v1 ◽

2020 ◽

Author(s):

Maurine Miner ◽

Linda-Gail Bekker ◽

Tamara Kredo ◽

Niresh Bhagwandin ◽

Lawrence Corey ◽

...

Keyword(s):

Hiv Prevention ◽

Medical Research ◽

South African ◽

Medical Research Council ◽

Standard Of Care ◽

Hiv Vaccine ◽

Hiv Vaccine Trials ◽

Treatment And Prevention ◽

Vaccine Trials ◽

Prevention Trials

Introduction: The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to standard of care (SoC) in HIV prevention clinical trials, both for treatment and prevention of disease. Policymakers, regulators, ethicists, experts in the law (as it pertains to medical research), researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. Discussion: Summit participants discussed how and when to include new modalities of HIV treatment and prevention into existing clinical practice guidelines, and by extension in clinical trial protocols. Participants involved in the execution of care and the scale-up of new interventions, in particular, the roll out of pre-exposure prophylaxis (PrEP), presented the opportunities for and challenges to scaling up interventions, and their experience with demonstration projects of PrEP. Advocates and community members propagated the need to make interventions that could avert HIV infection available as soon as possible. Experts in evidence-based guideline development discussed the nuances in evaluating evidence for policy and the mechanisms for getting medicines on the Essential Medicines List in South Africa. Given the variability in clinical trial efficacy of PrEP amongst different populations, scientists and statisticians discussed the various biological, virological and immunological reasons for this heterogeneity. Conclusions: Input was given as to the impact of introducing PrEP in other HIV prevention trials, and the considerations for the design of both antiretroviral (ARV)-based and non-ARV based HIV prevention trials. 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) support the safety monitoring of PrEP.

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Ensuring Access to HIV Prevention Services in South African HIV Vaccine Trials: Correspondence Between Guidelines and Practices

Public Health Ethics ◽

10.1093/phe/phu010 ◽

2014 ◽

Vol 7 (2) ◽

pp. 195-206 ◽

Cited By ~ 7

Author(s):

Z. Essack

Keyword(s):

Hiv Prevention ◽

South African ◽

Hiv Vaccine ◽

Prevention Services ◽

Hiv Vaccine Trials ◽

Vaccine Trials

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Willingness to participate in HIV vaccine research in a peri-urban South African community

International Journal of STD & AIDS ◽

10.1258/095646206775809259 ◽

2006 ◽

Vol 17 (3) ◽

pp. 176-179 ◽

Cited By ~ 17

Author(s):

J Smit ◽

K Middelkoop ◽

L Myer ◽

S Seedat ◽

L-G Bekker ◽

...

Keyword(s):

South African ◽

Hiv Vaccine ◽

Sub Saharan Africa ◽

Willingness To Participate ◽

Vaccine Research ◽

Substantial Impact ◽

Hiv Vaccine Trials ◽

Vaccine Trials ◽

Urban South ◽

African Community

Research on willingness to participate in HIV vaccine trials is important in preparations for HIV vaccine research, but there are few data from sub-Saharan Africa. We interviewed 198 individuals in a peri-urban South African community immediately after enrolment into an HIV vaccine preparedness study on their willingness to participate in hypothetical vaccine trials. Overall 23% of participants ( n = 46) said that they would be willing to participate in an HIV vaccine trial. Willingness was associated with increasing age, male gender, and increasing knowledge about vaccines generally and HIV vaccines specifically. In multivariate analysis, a 1-unit increase in HIV vaccine knowledge score was associated with a 10-fold increase in willingness to participate (adjusted odds ratio, 10.72, 95% confidence intervals: 4.40–26.12). These results suggest that while willingness to participate in HIV vaccine trials is relatively low in this setting, educational campaigns may have a substantial impact on individuals' willingness to participate in research.

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Exploring the Use of Oral Pre-exposure Prophylaxis (PrEP) Among Women from Durban, South Africa as Part of the HIV Prevention Package in a Clinical Trial

AIDS and Behavior ◽

10.1007/s10461-020-03072-0 ◽

2020 ◽

Author(s):

Ivana Beesham ◽

Renee Heffron ◽

Shannon Evans ◽

Jared M. Baeten ◽

Jenni Smit ◽

...

Keyword(s):

South Africa ◽

Hiv Prevention ◽

South African ◽

Medical Research Council ◽

Trial Site ◽

Study Staff ◽

Prevention Trials ◽

Post Trial ◽

Exposure Prophylaxis ◽

First Time

Abstract HIV endpoint-driven clinical trials in Africa enroll women who are at heightened risk of acquiring HIV. In 2017, the South African Medical Research Council recommended the provision of oral pre-exposure prophylaxis (PrEP) in HIV prevention trials, at which time the Evidence for Contraceptive Options and HIV Outcomes trial was ongoing and began to provide PrEP on-site at some trial sites. We interviewed 132 women who initiated PrEP on-site at the Durban, South Africa trial site to explore PrEP use, and conducted phone-based interviews 4–6 months post-trial exit to explore post-trial PrEP access. PrEP uptake was high (42.6%). Among women initiating PrEP on-site, 87.9% felt at risk of acquiring HIV. Most women (> 90%) heard of PrEP for the first time from study staff and three-quarters who initiated PrEP on-site continued at trial-exit. PrEP use declined post-trial exit with more than 50% of women discontinuing PrEP, and barriers relating to access emerged.

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