"Free Testing and PrEP without Outing Myself to Parents:" Motivation to participate in oral and injectable PrEP clinical trials among adolescent men who have sex with men.

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.