Abstract
BackgroundSouth Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials.MethodsSite staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n = 98) rated each recommendation on five dimensions: “Familiarity with”, “Ease of Understanding”, “Ease of Implementing”, “Perceived Protection”, and “Agreement with” each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups.ResultsBoth care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was “Ease of Implementing,” and the least problematic was “Agreement with,” suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations.ConclusionsWe propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for “Ease of Implementing”, and/ or “Ease of Understanding” in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations.
Highlights
South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015
The five lowest ranked recommendations were all prevention-related: The protocol should describe how stakeholders will negotiate adding new methods to the risk reduction package, New prevention methods should be added to the prevention package based on consultation among all stakeholders, Stakeholders should discuss disseminating results about how the standard of prevention was implemented in the trial, New prevention methods should be added to the prevention package as they are validated or approved by relevant authorities, and Trial participants should get access to all state of the art HIV prevention services
Overall merit of ethical recommendations The findings indicate that both care and prevention recommendations were rated favourably overall
Summary
South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. There has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials. The country has developed national standards on ethics for HIV vaccine research, namely the Medical Research Council of South Africa’s Guidelines on Ethics for Medical Research: HIV preventive vaccine trials [1], and domestic vaccine stakeholders are governed by international guidelines. Research into new prevention technologies and methods is vitally important in the battle against the epidemic. To this end, South Africa has conducted numerous HVTs since 2003. There are five sites currently implementing preventive HVT protocols, a massive scale up of site capacity is expected as South Africa prepares to implement a phase III licensure trial in the country in approximately 2015
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