A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men

项目摘要 我们的总体目标是在年轻的性少数男性中增加人乳头瘤病毒（HPV）疫苗接种 （YSMM）.性少数男性（即，与男性发生性关系或认同为同性恋或双性恋的男性） HPV感染和HPV相关疾病，包括肛门癌。HPV疫苗是针对性 26岁以下的少数男性，但18-26岁的YSMM中只有不到21%接受过任何HPV疫苗剂量 (i.e.,开始）和少于10%的人接受了所有三种推荐剂量（即，完成）。解决 针对这一问题，我们最近开发并试点测试了一种理论上知情的移动的健康HPV疫苗 YSMM（Outsmart HPV）据我们所知，Outsmart HPV是第一个HPV疫苗干预 为这一人群开发的。试点研究确定了干预措施的可行性和可接受性， 产生了非常有希望的初步数据。然而，这项研究的试点性质使我们无法正式 确定干预效果或审查其他干预机制进程。 拟议的研究是这一研究领域的关键下一步，因为它将建立在我们的试点研究基础上， 通过一项具有良好把握度的随机对照试验全面评估Outsmart HPV。我们将招募1995名 通过社交媒体从美国招募18-25岁未接种疫苗的YSMM，并将每位参与者随机分配至：a） 通过手机友好网站提供关于HPV和HPV疫苗的标准信息（对照组）; B）智取 具有单向疫苗提醒的HPV;或c）具有交互式疫苗提醒的智胜HPV。目标1将 确定Outsmart HPV对增加HPV疫苗启动和完成的功效。这样做 目的将确定哪种类型的HPV疫苗提醒（单向或互动）最有效 增加疫苗接种作为智取HPV干预的一部分。目标2将确定解释 研究组与HPV疫苗接种开始和完成之间的关系。这将通过以下方式确定机制： 干预影响HPV疫苗接种（即，干预如何导致理论变化 构建体，其又导致疫苗接种）。目标3将确定干预效果是否在关键 参与者的人口统计学和健康相关特征（即，适度）。这将使我们能够确定 如果智胜HPV在不同的亚组中有不同的疗效，如果是这样，确定那些 今后可能需要进一步调整干预措施。这项研究的结果将提供证据， 关于干预有效性、调解人和主持人的基础。这些发现将提供一个复杂的 了解Outsmart HPV，需要有效和高效地传播这一创新 在未来的YSMM干预。

PROJECT SUMMARY Our overall goal is to increase human papillomavirus (HPV) vaccination among young sexual minority men (YSMM). Sexual minority men (i.e., men who have sex with men or identify as gay or bisexual) have high rates of HPV infection and HPV-related disease, including anal cancer. HPV vaccine is recommended for sexual minority men through age 26, yet fewer than 21% of YSMM ages 18-26 have received any HPV vaccine doses (i.e., initiation) and fewer than 10% have received all three recommended doses (i.e., completion). To address this issue, we recently developed and pilot tested a theoretically-informed mobile health HPV vaccine intervention for YSMM (Outsmart HPV). To our knowledge, Outsmart HPV is the first HPV vaccine intervention developed for this population. The pilot study established the intervention’s feasibility and acceptability and produced very promising preliminary data. However, the pilot nature of this study precluded us from formally establishing intervention efficacy or examining additional intervention mechanism processes. The proposed study is a critical next step in this line of research because it will build upon our pilot study to comprehensively evaluate Outsmart HPV via a well-powered randomized controlled trial. We will recruit 1995 unvaccinated YSMM ages 18-25 from the US via social media and randomize each participant to either: a) standard information about HPV and HPV vaccine via a mobile-friendly website (control group); b) Outsmart HPV with unidirectional vaccine reminders; or c) Outsmart HPV with interactive vaccine reminders. Aim 1 will determine the efficacy of Outsmart HPV on increasing HPV vaccine initiation and completion. In doing so, the aim will determine which type of HPV vaccine reminders (unidirectional or interactive) most effectively increases vaccination as part of the Outsmart HPV intervention. Aim 2 will identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion. This will identify the mechanism by which the intervention affects HPV vaccination (i.e., how the intervention leads to changes in theoretical constructs which in turn lead to vaccination). Aim 3 will determine if intervention efficacy differs across key demographic and health-related characteristics of participants (i.e., moderation). This will allow us to determine if Outsmart HPV has differential efficacy across subgroups and, if so, to identify those men for whom the intervention may require further adaptation in the future. Results of the proposed study will provide an evidence base regarding intervention efficacy, mediators, and moderators. These findings will offer a sophisticated understanding of Outsmart HPV that is needed to effectively and efficiently disseminate this innovative intervention to YSMM in the future.