Knopf, Amelia S.Ott, Mary A.Liu, NancyKapogiannis, Bill G.Zimet, Gregory D.Fortenberry, J. DennisHosek, Sybil G.2019-05-222019-05-222017-12Knopf, A. S., Ott, M. A., Liu, N., Kapogiannis, B. G., Zimet, G. D., Fortenberry, J. D., & Hosek, S. G. (2017). Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV. The Journal of adolescent health : official publication of the Society for Adolescent Medicine, 61(6), 747–754. doi:10.1016/j.jadohealth.2017.06.013https://hdl.handle.net/1805/19429PURPOSE: There is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors' access to biomedical HIV prevention technologies is impeded by the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention. METHODS: Data for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating and 58 enrolled. RESULTS: Participants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes. CONCLUSIONS: Participants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision-making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy.en-USPublisher PolicyBiomedical ethicsConsentHIVLGBTQPre-exposure prophylaxisPreventionArticle