Katz Ariana W K, Mensch Barbara S, Woeber Kubashni, Musara Petina, Etima Juliane, van der Straten Ariane
Women's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA.
Population Council, New York, NY, USA.
BMC Womens Health. 2019 Jan 25;19(1):18. doi: 10.1186/s12905-019-0713-6.
In 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.
VOICE-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.
Participants 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.
Women'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.
NCT02358616 ; Posted February 9, 2015, retrospectively registered.
在生物医学预防试验中，正确且一致地使用研究产品对于确定疗效至关重要。在VOICE试验（一项关于用于预防HIV的阴道凝胶和口服片剂的2B期随机试验）中，产品依从性较低（约34%），但自我报告的依从性和保留率较高（>90%）。这项来自VOICE-D（一项试验后的定性辅助研究）的分析探讨了参与VOICE试验的动机，以及试验既定优先事项与参与者之间可能存在的不一致来源。
VOICE-D招募了171名VOICE试验的前参与者，以调查除其他事项外，参与并留在试验中的原因。当地语言的深入访谈和焦点小组讨论被转录并翻译成英语，并使用NVivo进行编码和分析。还分析了从106名参与者的VOICE终止访视调查中获得的参与动机数据，以证实VOICE-D的研究结果。
参与者主要是为了个人健康益处（如免费医疗保健和HIV检测）而参与，并表示出于对试验的责任感而继续参与。利他动机是终止访视调查中最常提及的动机；从定性角度来看，许多陈述利他原因的人也希望获得个人健康益处。很少有人提到为了经济补偿而参与。社交网络影响了招募并传播了治疗性误解。
女性为了个人健康益处而参与试验，凸显了她们监测自身HIV风险和整体健康状况的愿望。帮助参与者将研究产品的使用视为改善社会资本，并提醒参与者他们的研究责任，可能会改善试验结果。了解参与研究的原因将有助于确保研究人员和参与者的优先事项保持一致。
NCT02358616；于2015年2月9日发布，追溯注册。
