Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 17, 2019
Date Accepted: Nov 12, 2019
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Protocol for a Randomized Controlled Trial of a Web-Based HPV Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex with Men
ABSTRACT
Background:
Gay, bisexual, and other men who have sex with men experience several disparities related to human papillomavirus (HPV) infection, including high incidence rates of anal cancer. HPV vaccine is currently recommended for young adults, yet HPV vaccine coverage is low among young gay, bisexual, and other men who have sex with men (YGBMSM).
Objective:
We describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a population-targeted, individually-tailored web-based HPV vaccination intervention for YGBMSM. The RCT is designed to determine the efficacy of the intervention, the mechanism by which the intervention has an effect (i.e., mediation), and whether efficacy varies by participant characteristics (i.e., moderation).
Methods:
Outsmart HPV was previously developed and pilot-tested. The current study is a three-arm prospective RCT that will enroll a projected 1995 YGBMSM who are ages 18-25, live in the United States, and have not received any doses of HPV vaccine. Participants will be recruited via paid advertisements on social media sites and randomized to receive either: (a) standard information online about HPV vaccine (control group); (b) Outsmart HPV content online with monthly unidirectional vaccination reminders sent via text message; or (c) Outsmart HPV content online with monthly interactive vaccination reminders sent via text message. Participants will complete online surveys at four time points during the study: baseline; immediately after engaging with online content; three months after randomization; and nine months after randomization. Primary outcomes will include both HPV vaccine initiation (i.e., receipt of one or more doses of HPV vaccine) and completion (receipt of all three doses recommended for this age range). We will examine constructs from the intervention’s theoretical framework as potential mediators, and we will examine demographic and health-related characteristics as potential moderators of intervention effects.
Results:
The Institutional Review Board at The Ohio State University has approved the study. Materials have been developed and finalized for all study groups. Recruitment for the RCT is scheduled to begin in Fall 2019.
Conclusions:
If shown to be efficacious, Outsmart HPV has the potential to fill an important gap by promoting HPV vaccination among a population at increased risk of HPV infection and HPV-related disease. Clinical Trial: The trial is registered at ClinicalTrials.gov: NCT04032106 (available at: https://clinicaltrials.gov/ct2/show/NCT04032106).
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Copyright
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