||5R37CA226682-03 Interpret this number
||Ohio State University
||A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men
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.
A Web-Based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
, Gower A.L.
, Kiss D.E.
, Malone M.A.
, Katz M.L.
, Bauermeister J.A.
, Shoben A.B.
, Paskett E.D.
, McRee A.L.
JMIR research protocols, 2020-02-24; 9(2), p. e16294.