Toledo Lauren, McLellan-Lemal Eleanor, Henderson Faith L, Kebaabetswe Poloko M
ICF International, Atlanta, USA; Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, USA.
Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, USA.
World J AIDS. 2015 Mar;5(2):10-20. doi: 10.4236/wja.2015.51002. Epub 2015 Feb 12.
Recent clinical trials have shown that a daily dose of oral TDF/FTC pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency (HIV) risk. Understanding trial participants' perspectives about retention and PrEP adherence is critical to inform future PrEP trials and the scale-up and implementation of PrEP programs. We analyzed 53 in-depth interviews conducted in April 2010 with participants in the TDF2 study, a Phase 3, randomized, double-blind, placebo-controlled clinical trial of daily oral TDF/FTC with heterosexual men and women in Francistown and Gaborone, Botswana. We examined participants' knowledge, attitudes, and experiences of the trial, identified facilitators and barriers to enrollment and retention, and compared participant responses by study site, sex, and study drug adherence. Our findings point to several factors to consider for participant retention and adherence in PrEP trials and programs, including conducting pre-enrollment education and myth reduction counseling, providing accurate estimates of participant obligations and side effect symptoms, ensuring participant understanding of the effects of non-adherence, gauging personal commitment and interest in study outcomes, and developing a strong external social support network for participants.
近期临床试验表明，每日口服替诺福韦酯/恩曲他滨暴露前预防（PrEP）药物可有效降低感染人类免疫缺陷病毒（HIV）的风险。了解试验参与者对于持续参与试验及坚持服用PrEP药物的看法，对于指导未来的PrEP试验以及扩大PrEP项目的规模并付诸实施至关重要。我们分析了2010年4月对参与TDF2研究的参与者进行的53次深入访谈，该研究是一项3期随机双盲安慰剂对照临床试验，在博茨瓦纳弗朗西斯敦和哈博罗内，让异性恋男女每日口服替诺福韦酯/恩曲他滨。我们考察了参与者对试验的了解、态度和体验，确定了参与招募及持续参与试验的促进因素和障碍，并按研究地点、性别和研究药物依从性对参与者的回答进行了比较。我们的研究结果指出了在PrEP试验和项目中，为提高参与者持续参与试验及坚持服药率需要考虑的几个因素，包括开展入组前教育和破除误解咨询，准确告知参与者所需承担的责任和副作用症状，确保参与者了解不坚持服药的后果，评估个人对研究结果的投入程度和兴趣，以及为参与者建立强大的外部社会支持网络。
