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. Although the HPV vaccine is currently recommended for young adults, HPV vaccine coverage is modest 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 (ie, mediation), and whether efficacy varies by participant characteristics (ie, moderation). Methods: Outsmart HPV was previously developed and pilot-tested. This study is a 3-arm prospective RCT that will enroll a projected 1995 YGBMSM who are aged 18 to 25 years, live in the United States, and have not received any doses of the HPV vaccine. Participants will be recruited by means of paid advertisements on social media sites and randomized to receive (1) standard information on the Web about HPV vaccine (control group), (2) Outsmart HPV content on the Web with monthly unidirectional vaccination reminders sent via text messages, or (3) Outsmart HPV content on the Web with monthly interactive vaccination reminders sent via text messages. Participants will complete Web-based surveys at 4 time points during the study: baseline, immediately after engaging with Web-based content, 3 months after randomization, and 9 months after randomization. Primary outcomes will include both HPV vaccine initiation (ie, receipt of 1 or more doses of the HPV vaccine) and completion (receipt of all 3 doses recommended for this age range). We will examine constructs from the intervention's theoretical framework as potential mediators and 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 began 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.
Bibliographical noteFunding Information:
The authors wish to thank members of their project advisory board for their valuable input and feedback. The research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number R37CA226682 (originally awarded as R01CA226682). Additional support was provided from the Center for Health Communications Research at the University of Michigan (P30CA046592) and the Behavioral Measurement Shared Resource at The Ohio State University Comprehensive Cancer Center (P30CA016058). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
The project has been funded by the National Cancer Institute of the National Institutes of Health under Award Number R37CA226682 (originally awarded as R01CA226682). The institutional review board at The Ohio State University has approved this study (study number 2019C0028). The Ohio State University served as the reviewing institution with other study sites ceding review. We have also registered this clinical trial (NCT04032106). Recruitment and enrollment for the RCT began in Fall 2019.
PR has received research grants from Merck Sharp & Dohme Corp and Cervical Cancer-Free America through an unrestricted educational grant from GlaxoSmithKline. EP has received research grants from Merck Sharp & Dohme Corp. These funds were not used to support this research study. None of the other authors have any conflicts of interest to declare.
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- Gay or bisexual
- Human papillomavirus
- Human papillomavirus vaccination
- Men who have sex with men
- Young adult