Center for Ethics Education, HIV/Drug Abuse Prevention Research Ethics Institute, and Department of Psychology, Fordham University, Dealy Hall, Bronx, NY, 10458, USA.
Stoney Brook School of Medicine, Stoney Brook, NY, USA.
AIDS Behav. 2021 May;25(5):1606-1618. doi: 10.1007/s10461-020-03077-9. Epub 2020 Nov 27.
Adherence to oral pre-exposure prophylaxis (PrEP) is challenging for adolescent males who have sex with males (AMSM). Once adult trials comparing oral to longer lasting injectable PrEP are completed, there will be a need for adolescent studies. However, lack of data on adolescent consent capacity may sustain guardian permission requirements identified as a barrier to AMSM participation in prior PrEP trials. This online study assessed AMSM's (14-17 years) consent capacity for these trials, comparing performance to MSM (18-19 years) for whom guardian permission is not required. Applying the MacCAT-CR, participants (N = 214) viewed a video and mock consent form followed by open-ended and yes/no items. Cognitive diagnostic models and means testing analyses supported AMSM capacity to consent to these trials: 16-17 and most 14-15 year-olds, demonstrated consent understanding, appreciation and reasoning at 18-19 year-old levels. Data also identified vulnerabilities requiring attention during informed consent.
青少年男男性行为者（AMSM）坚持口服暴露前预防（PrEP）有一定难度。一旦完成比较口服和更持久的注射性 PrEP 的成人试验，就需要开展青少年研究。然而，缺乏关于青少年同意能力的数据可能会维持监护人同意要求，这被认为是先前 PrEP 试验中 AMMS 参与的障碍。这项在线研究评估了 AMSM（14-17 岁）对这些试验的同意能力，将其表现与 MSM（18-19 岁）进行了比较，后者不需要监护人同意。通过应用 MacCAT-CR，参与者（N=214）观看了一段视频和模拟同意书，然后回答了开放性和是/否问题。认知诊断模型和均值检验分析支持 AMSM 有能力同意参加这些试验：16-17 岁和大多数 14-15 岁的青少年在 18-19 岁的水平上表现出同意理解、欣赏和推理。数据还确定了在知情同意过程中需要注意的脆弱性。
