Abstract
BackgroundPROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design.MethodsParticipants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants.ResultsAcceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported ‘being deferred’ as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design.ConclusionThe quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in this study.
Highlights
Randomised placebo-controlled trials are considered the ‘gold standard’ when evaluating an investigational product for prevention
University College London and an innovations grant from Public Health England, and most clinics received support through the UK National Institute of Health Research Clinical Research Network
Randomised placebo-controlled trials have provided a breakthrough in HIV prevention by demonstrating the benefit of oral and topical pre-exposure prophylaxis (PrEP) [1,2,3,4,5,6,7]
Summary
Randomised placebo-controlled trials are considered the ‘gold standard’ when evaluating an investigational product for prevention. Randomised placebo-controlled trials have provided a breakthrough in HIV prevention by demonstrating the benefit of oral and topical pre-exposure prophylaxis (PrEP) [1,2,3,4,5,6,7]. The NecessityConcerns-Framework (NCF) predicts adherence by measuring an individual’s belief about the necessity of taking medication balanced against their concerns about taking it [14, 15] This balance of necessity and concern is skewed against adherence in placebo-controlled trials where there is no benefit of taking a placebo, unclear benefit of taking the investigational product, and a heightened focus on potential side effects [16]. We report on the acceptability of this open-label wait-listed trial design
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