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

Paul L Reiter, Amy L Gower, Dale E Kiss, Molly A Malone, Mira L Katz, Jose A Bauermeister, Abigail B Shoben, Electra D Paskett, Annie-Laurie McRee, Paul L Reiter, Amy L Gower, Dale E Kiss, Molly A Malone, Mira L Katz, Jose A Bauermeister, Abigail B Shoben, Electra D Paskett, Annie-Laurie McRee

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. 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.

Trial registration: ClinicalTrials.gov NCT04032106; https://ichgcp.net/clinical-trials-registry/NCT04032106.

International registered report identifier (irrid): PRR1-10.2196/16294.

Keywords: gay or bisexual; human papillomavirus; human papillomavirus vaccination; intervention; men who have sex with men; young adult.

Conflict of interest statement

Conflicts of Interest: 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.

©Paul L L Reiter, Amy L Gower, Dale E Kiss, Molly A Malone, Mira L Katz, Jose A Bauermeister, Abigail B Shoben, Electra D Paskett, Annie-Laurie McRee. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.02.2020.

Figures

Figure 1
Figure 1
Overview of the randomized controlled trial for the Outsmart HPV intervention. HPV: human papillomavirus; Out-I group: Outsmart HPV that includes monthly interactive vaccination reminders; Out-U group: Outsmart HPV that includes monthly unidirectional vaccination reminders.
Figure 2
Figure 2
Screenshot from a smartphone of the Outsmart HPV intervention showing the 4 sequential sections. Both intervention arms (Outsmart HPV that includes monthly interactive vaccination reminders and Outsmart HPV that includes monthly unidirectional vaccination reminders groups) will receive this content.
Figure 3
Figure 3
Screenshot from a tablet computer of the Get Answers section of Outsmart HPV. Presentation of content is individually tailored to prioritize participants’ barriers and concerns about the human papillomavirus vaccine, as indicated on the baseline survey.
Figure 4
Figure 4
Outsmart HPV Action Plan on a desktop computer and a tablet computer. The plan is informed by participants’ engagement with the project website and includes a goal date for getting the first dose of the human papillomavirus vaccine series, schedule for subsequent doses, next steps for getting vaccinated, and tailored information for taking these next steps. Participants may revisit the plan on the study website or save/print a copy for future reference.
Figure 5
Figure 5
Example of an interactive human papillomavirus vaccination reminder that includes an initial prompted message and subsequent communications. As shown, some of the communications will contain a meme or brief animation in Graphics Interchange Format.

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