Dataset Information

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.

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; http://clinicaltrials.gov/show/NCT04032106. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/16294.

SUBMITTER: Reiter PL

PROVIDER: S-EPMC7063529 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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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.

Reiter Paul L PL Gower Amy L AL Kiss Dale E DE Malone Molly A MA Katz Mira L ML Bauermeister Jose A JA Shoben Abigail B AB Paskett Electra D ED McRee Annie-Laurie AL

JMIR research protocols 20200224 2

<h4>Background</h4>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).<h4>Objective</h4>We describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a ...[more]

PMID: 32130192

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Project description:Web-based approaches, specifically social media sites, represent a promising approach for recruiting young gay and bisexual men for research studies. Little is known, however, about how the performance of social media advertisements (ads) used to recruit this population is affected by ad content (ie, image and text).The aim of this study was to evaluate the effects of different images and text included in social media ads used to recruit young gay and bisexual men for the pilot test of a Web-based human papillomavirus (HPV) vaccination intervention.In July and September 2016, we used paid Facebook advertisements to recruit men who were aged 18-25 years, self-identified as gay or bisexual, US resident, and had not received HPV vaccine. A 4x2x2 factorial experiment varied ad image (a single young adult male, a young adult male couple, a group of young adult men, or a young adult male talking to a doctor), content focus (text mentioning HPV or HPV vaccine), and disease framing (text mentioning cancer or a sexually transmitted disease [STD]). Poisson regression determined whether these experimental factors affected ad performance.The recruitment campaign reached a total of 35,646 users who viewed ads for 36,395 times. This resulted in an overall unique click-through rate of 2.01% (717/35,646) and an overall conversion rate of 0.66% (241/36,395). Reach was higher for ads that included an image of a couple (incidence rate ratio, IRR=4.91, 95% CI 2.68-8.97, P<.001) or a group (IRR=2.65, 95% CI 1.08-6.50, P=.03) compared with those that included an image of a single person. Ads that included an image of a couple also had a higher conversion rate (IRR=2.56, 95% CI 1.13-5.77, P=.02) than ads that included an image of a single person. Ads with text mentioning an STD had a higher unique click-through rate compared with ads with text mentioning cancer (IRR=1.34, 95% CI 1.06-1.69, P=.01). The campaign cost a total of US $413.72 and resulted in 150 eligible and enrolled individuals (US $2.76 per enrolled participant).Facebook ads are a convenient and cost-efficient strategy for reaching and recruiting young gay and bisexual men for a Web-based HPV vaccination intervention. To help optimize ad performance among this population, researchers should consider the importance of the text and image included in the social media recruitment ads.

Project description:BackgroundGay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners.ObjectiveTo describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure.MethodsSex Positive!([+]) is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility).ResultsParticipant recruitment began in June 2015 and ended in December 2015.ConclusionsThis protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive!([+]) intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed.ClinicaltrialClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG).

Dataset Information

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.

Publications

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.

Similar Datasets

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