Center for Ethics Education, Fordham University, New York, New York, United States of America.
Clinical Psychology Department, Midwestern University, Glendale, Arizona, United States of America.
PLoS One. 2018 Jul 25;13(7):e0200560. doi: 10.1371/journal.pone.0200560. eCollection 2018.
Adolescent men who have sex with men (AMSM) account for disproportionately high numbers of new HIV diagnoses. Non-adherence to daily use limiting the effectiveness of oral PrEP (Truvada) has led to current trials with adult MSM testing Cabotegravir, a long-term injectable medication. Once comparative studies with young adult MSM have established relative safety and efficacy of these medications, there will be a need for such comparative trials involving adolescents. Trends in state laws and IRB protocol review indicate that many of these studies will permit youth to provide independent consent for participation. Understanding the motivations of AMSM to participate in HIV biomedical prevention studies is important to ensure their agreement is voluntary without misunderstanding and undue influence. This study examined AMSM attitudes toward participation in oral/injectable PrEP RCTs to inform protections of youth's rights and welfare in future studies.
We administered to 198 ethnically diverse U.S. AMSM, 14-17 years, a web-based survey including demographic and sexual health questions, description of a year-long oral versus injectable PrEP RCT and 26 Likert-type and one open-ended item assessing motivations for and against participation including: perceived benefits and risks of PrEP; free HIV/STI testing and counseling; confidentiality concerns; random assignment; and benefit to others.
Sixty-two percent indicated they were likely to participate in the study. The majority endorsed daily HIV protection, free HIV/STI testing, sexual health counseling, not having to rely on partner's condom use, and altruism as reasons to participate. Reasons against participation included medication side effects, concern taking the pill daily and clinic visits would reveal their sexual orientation and behaviors to parents. Over half erroneously assumed they would be assigned to the condition best for them and 39% indicated free access to services would lead them to participate even if they did not want to. Multiple regression indicated these factors accounted for 55% of the variance in participation choice. Nether age or ethnicity yielded significance.
Results suggest future biomedical HIV prevention research will need to develop procedures to address AMSM's confidentiality concerns, enhance youth's understanding of random assignment, the continued importance of medication adherence and partner condom use during trial participation, and availability of alternative sexual health services to avoid the potentially undue influence of access to free sexual health services.
与男性发生性关系的青少年男性（AMSM）占新 HIV 诊断数量的不成比例的高比例。由于每日使用 Truvada（一种口服暴露前预防药物）不依从，导致目前正在对成年男男性行为者进行卡博特格雷韦的临床试验，卡博特格雷韦是一种长效注射药物。一旦在年轻成年男男性行为者中进行了这些药物的相对安全性和有效性的比较研究，就需要在青少年中进行此类比较研究。州法律和 IRB 协议审查的趋势表明，许多此类研究将允许年轻人为参与提供独立同意。了解 AMSM 参与 HIV 生物医学预防研究的动机对于确保他们的同意是自愿的，没有误解和不当影响非常重要。本研究检查了 AMSM 对参与口服/注射用 PrEP RCT 的态度，以为未来研究中保护青年的权利和福利提供信息。
我们向 198 名美国 AMSM（14-17 岁）提供了一项基于网络的调查，包括人口统计学和性健康问题、为期一年的口服与注射用 PrEP RCT 描述以及 26 个李克特量表和一个开放式问题，评估了参与和反对的动机，包括：对 PrEP 的感知益处和风险；免费的 HIV/性传播感染检测和咨询；保密性问题；随机分配；以及对他人的好处。
62%的人表示他们可能会参与这项研究。大多数人赞成每天预防 HIV、免费的 HIV/性传播感染检测、性健康咨询、不必依赖伴侣使用避孕套以及利他主义作为参与的理由。反对参与的原因包括药物副作用、担心每天服用药丸以及就诊会向父母透露他们的性取向和行为。超过一半的人错误地认为他们会被分配到对他们最有利的条件，39%的人表示免费获得服务会导致他们参与，即使他们不想参与。多元回归分析表明，这些因素解释了参与选择的 55%的方差。年龄或种族均无显著性差异。
结果表明，未来的 HIV 生物医学预防研究将需要制定程序来解决 AMSM 的保密性问题，增强年轻人对随机分配的理解，在试验参与期间继续重视药物依从性和伴侣使用避孕套，以及提供替代的性健康服务，以避免免费性健康服务的潜在不当影响。
