A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men

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PROJECT SUMMARY Our overall goal is to increase human papillomavirus (HPV) vaccination among young sexual minority men (YSMM). Sexual minority men (i.e., men who have sex with men or identify as gay or bisexual) have high rates of HPV infection and HPV-related disease, including anal cancer. HPV vaccine is recommended for sexual minority men through age 26, yet fewer than 21% of YSMM ages 18-26 have received any HPV vaccine doses (i.e., initiation) and fewer than 10% have received all three recommended doses (i.e., completion). To address this issue, we recently developed and pilot tested a theoretically-informed mobile health HPV vaccine intervention for YSMM (Outsmart HPV). To our knowledge, Outsmart HPV is the first HPV vaccine intervention developed for this population. The pilot study established the intervention’s feasibility and acceptability and produced very promising preliminary data. However, the pilot nature of this study precluded us from formally establishing intervention efficacy or examining additional intervention mechanism processes. The proposed study is a critical next step in this line of research because it will build upon our pilot study to comprehensively evaluate Outsmart HPV via a well-powered randomized controlled trial. We will recruit 1995 unvaccinated YSMM ages 18-25 from the US via social media and randomize each participant to either: a) standard information about HPV and HPV vaccine via a mobile-friendly website (control group); b) Outsmart HPV with unidirectional vaccine reminders; or c) Outsmart HPV with interactive vaccine reminders. Aim 1 will determine the efficacy of Outsmart HPV on increasing HPV vaccine initiation and completion. In doing so, the aim will determine which type of HPV vaccine reminders (unidirectional or interactive) most effectively increases vaccination as part of the Outsmart HPV intervention. Aim 2 will identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion. This will identify the mechanism by which the intervention affects HPV vaccination (i.e., how the intervention leads to changes in theoretical constructs which in turn lead to vaccination). Aim 3 will determine if intervention efficacy differs across key demographic and health-related characteristics of participants (i.e., moderation). This will allow us to determine if Outsmart HPV has differential efficacy across subgroups and, if so, to identify those men for whom the intervention may require further adaptation in the future. Results of the proposed study will provide an evidence base regarding intervention efficacy, mediators, and moderators. These findings will offer a sophisticated understanding of Outsmart HPV that is needed to effectively and efficiently disseminate this innovative intervention to YSMM in the future.