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. 2021 May;25(5):1606-1618.
doi: 10.1007/s10461-020-03077-9. Epub 2020 Nov 27.

Competence to Consent to Oral and Injectable PrEP Trials Among Adolescent Males Who Have Sex with Males

Celia B Fisher  1 , Leah Ibrahim Puri  2 , Kathryn Macapagal  3 , Leah Feuerstahler  4 , Jungwon Rachael Ahn  4 , Brian Mustanski  3
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Competence to Consent to Oral and Injectable PrEP Trials Among Adolescent Males Who Have Sex with Males

Celia B Fisher et al. AIDS Behav. 2021 May.

Abstract

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.

Keywords: Adolescent sexual minority males; HIV prevention; Informed consent; MacCAT-CR; Pre-exposure prophylaxis (PrEP); Randomized clinical trials.

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