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.

Automated summary

The study assessed adolescent males who have sex with males (AMSM) consent capacity for oral PrEP trials, finding that 16-17 year olds and most 14-15 year olds demonstrated understanding, appreciation, and reasoning at levels similar to adults. The data also identified vulnerabilities that need attention during informed consent.