Abstract
BackgroundIn biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants.MethodsVOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings.ResultsParticipants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception.ConclusionsWomen’s participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants.Trial registrationNCT02358616; Posted February 9, 2015, retrospectively registered.
Highlights
In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy
Ugandan participants, who included more sex workers than other sites, had significantly more lifetime sexual partners and they were more likely to know that their partners had other partners (56%), while South Africans and Zimbabweans were more commonly unsure (79 and 76% respectively)
A higher proportion of South African participants were in the highest socio-economic status (SES) bracket (47%), while Ugandans were more likely to be in the lowest bracket (76%)
Summary
Correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants. Further analysis revealed that product adherence was low (estimated at only 34%), despite high self-reported adherence and overall trial retention (> 90%), and low amounts of returned unused products [10] To further explore these results, a qualitative ancillary study, MTN-003D /VOICE-D, was implemented after the completion of VOICE. This paper uses the VOICE-D sample to focus on motivations to join and remain in the VOICE trial, and possible sources of misalignment between the stated priorities of participants and those of the trial
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
