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

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.