Testing a Web-Based Parent-Focused HIV Prevention Intervention for Gay and Bisexual Adolescents: Protocol for a Randomized Controlled Trial.

Abstract

Among US teenagers, 79% of HIV infections are attributable to male-to-male sexual contact; yet, few interventions have been shown to effectively reduce sexual risk among gay and bisexual adolescents (GBA). Parent communication about sex is associated with adolescent sexual risk, and interventions to improve parent communication have been shown to successfully reduce sexual risk among heterosexual samples. However, no interventions designed specifically for parents of GBA have been tested in clinical trials. Parents and Adolescent Talking About Healthy Sexuality (PATHS) is a web-based intervention we created for parents of GBA that aims to improve parent communication about sexuality and HIV and increase parent behaviors supportive of GBA sexual health. This trial aims to test whether delivering PATHS to parents of GBA ages 14-19 years will improve GBA sexual health outcomes in the 6 months following intervention delivery. Secondary aims are to test whether the intervention's effects are sustained at 12 months after the intervention and to examine whether effects are mediated through specific parent behaviors. In total, 350 parents of GBA will be recruited online via social media advertising and randomized to receive either PATHS or an active control. PATHS is fully automated, self-paced, and can be completed in a single session lasting under an hour. The active control is an education entertainment film created to provide general support and guidance to parents of GBA. Both parents and their GBA sons will complete online assessments every 3 months over a 1-year period. Primary outcomes will be evaluated at 6 months after the intervention, and then, the control arm will crossover and receive PATHS, and dyads will be followed for another 6 months. Primary outcomes include both adolescent sexual preparedness (eg, condom skills) as well as HIV-related sexual risk behavior (ie, condomless anal or vaginal sex that is not protected by pre-exposure prophylaxis). The study was funded in March 2022, and we completed enrollment of 393 parent-GBA dyads in September 2025. We project that all participants will have completed study activities by November 2026, with data analysis and results of the trial forthcoming in the first quarter of 2027. If proven efficacious, PATHS will be among the first HIV prevention interventions shown to reduce sexual risk for GBA. Moreover, as other adolescent-focused interventions emerge, PATHS' unique focus on parents will offer a complementary, additional means for reaching GBA who do not engage with other intervention options. ClinicalTrials.gov NCT05852600; https://clinicaltrials.gov/study/NCT05852600. PRR1-10.2196/81316.