Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: A qualitative study exploring HVTN staff perspectives

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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Developing countries to decide on HIV vaccine trials

Inpharma Weekly ◽

10.2165/00128413-199409610-00005 ◽

1994 ◽

Vol &NA; (961) ◽

pp. 5 ◽

Cited By ~ 1

Author(s):

&NA;

Keyword(s):

Developing Countries ◽

Hiv Vaccine ◽

Hiv Vaccine Trials ◽

Vaccine Trials

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A qualitative assessment of perspectives on the inclusion of adolescents in HIV vaccine trials in South Africa

International Journal of STD & AIDS ◽

10.1258/ijsa.2009.008484 ◽

2010 ◽

Vol 21 (3) ◽

pp. 172-176 ◽

Cited By ~ 9

Author(s):

H B Jaspan ◽

N F Soka ◽

C Mathews ◽

A J Flisher ◽

D Mark ◽

...

Keyword(s):

South Africa ◽

Hiv Vaccine ◽

Qualitative Assessment ◽

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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Contraceptive Use in Women Enrolled into Preventive HIV Vaccine Trials: Experience from a Phase I/II Trial in East Africa

PLoS ONE ◽

10.1371/journal.pone.0005164 ◽

2009 ◽

Vol 4 (4) ◽

pp. e5164 ◽

Cited By ~ 15

Author(s):

Hannah Kibuuka ◽

David Guwatudde ◽

Robert Kimutai ◽

Lucas Maganga ◽

Leonard Maboko ◽

...

Keyword(s):

Phase I ◽

East Africa ◽

Contraceptive Use ◽

Hiv Vaccine ◽

Hiv Vaccine Trials ◽

Vaccine Trials

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“Why Don’t You Go Into Suburbs? Why Are You Targeting Us?”: Trust and Mistrust in HIV Vaccine Trials in South Africa

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264618804740 ◽

2018 ◽

Vol 13 (5) ◽

pp. 525-536 ◽

Cited By ~ 4

Author(s):

Siyabonga Thabethe ◽

Catherine Slack ◽

Graham Lindegger ◽

Abigail Wilkinson ◽

Douglas Wassenaar ◽

...

Keyword(s):

Vaccine Trial ◽

Hiv Vaccine ◽

Community Advisory Board ◽

Future Research ◽

Community Members ◽

Group Discussions ◽

Hiv Vaccine Trials ◽

Vaccine Trials ◽

Community Stakeholders ◽

Site Staff

Trust is a key element of high-quality stakeholder relations, which are themselves essential for the success of HIV vaccine trials. Where trust is absent, community stakeholders might not volunteer to become involved in key trial activities, and potential participants might not volunteer for enrollment. We explored site staff and Community Advisory Board (CAB) members’ experiences of trust/mistrust among community members and potential participants. We analyzed 10 focus group discussions with site staff and CAB members at two active South African HIV vaccine trial sites. We report on key characteristics perceived to contribute to the trustworthiness of communicators, as well as factors associated with mistrust. Attributes associated with trustworthy communicators included shared racial identity, competence, and independence (not being “captured”). Key foci for mistrust included explanations about site selection, stored samples, vaccination, and Vaccine Induced Sero-Positivity (VISP). Our findings suggest that community members’ trust is not necessarily global, in which trials are trusted or not; rather, it appears fairly nuanced and is impacted by various perceived attributes of communicators and the information they provide. We make recommendations for clinical trial site stakeholders invested in building trust and for future research into trust at these sites.

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