Reiter Paul L, Gower Amy L, Kiss Dale E, Malone Molly A, Katz Mira L, Bauermeister Jose A, Shoben Abigail B, Paskett Electra D, McRee Annie-Laurie
The Ohio State University College of Public Health, Columbus, OH, United States.
The Ohio State University Comprehensive Cancer Center, Columbus, OH, United States.
JMIR Res Protoc. 2020 Feb 24;9(2):e16294. doi: 10.2196/16294.
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).
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).
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.
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.
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.
ClinicalTrials.gov NCT04032106; http://clinicaltrials.gov/show/NCT04032106.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16294.
男同性恋者、双性恋者以及其他与男性发生性行为的男性在人乳头瘤病毒（HPV）感染方面存在多种差异，包括肛门癌的高发病率。尽管目前建议年轻人接种HPV疫苗，但在年轻的男同性恋者、双性恋者以及其他与男性发生性行为的男性（YGBMSM）中，HPV疫苗接种率并不高。
我们描述了一项随机对照试验（RCT）的设计和方法，以严格评估“智胜HPV”，这是一种针对YGBMSM群体、个性化定制的基于网络的HPV疫苗接种干预措施。该RCT旨在确定干预措施的效果、干预措施产生效果的机制（即中介作用）以及效果是否因参与者特征而异（即调节作用）。
“智胜HPV”此前已开发并进行了试点测试。本研究是一项三臂前瞻性RCT，预计将招募1995名年龄在18至25岁之间、居住在美国且未接种过任何剂量HPV疫苗的YGBMSM。参与者将通过社交媒体网站上的付费广告招募，并随机分为三组，分别接受：（1）关于HPV疫苗的标准网络信息（对照组）；（2）网络上的“智胜HPV”内容，并通过短信每月发送单向疫苗接种提醒；或（3）网络上的“智胜HPV”内容，并通过短信每月发送交互式疫苗接种提醒。在研究期间，参与者将在4个时间点完成基于网络的调查：基线、接触网络内容后立即、随机分组后3个月以及随机分组后9个月。主要结局将包括HPV疫苗接种起始（即接种1剂或更多剂HPV疫苗）和完成情况（接种该年龄范围推荐的全部3剂疫苗）。我们将检验干预措施理论框架中的构建作为潜在中介因素，以及人口统计学和健康相关特征作为干预效果的潜在调节因素。
俄亥俄州立大学的机构审查委员会已批准该研究。所有研究组的材料均已开发并最终确定。RCT的招募工作于2019年秋季开始。
如果证明有效，“智胜HPV”有可能通过促进HPV感染和HPV相关疾病风险增加人群的HPV疫苗接种来填补一个重要空白。
ClinicalTrials.gov NCT04032106；http://clinicaltrials.gov/show/NCT04032106。
国际注册报告识别码（IRRID）：PRR1-10.2196/16294。
