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

项目总结 我们的总体目标是在年轻的性少数族裔男性中增加人类乳头瘤病毒(HPV)疫苗接种 (YSMM)。性少数男性(即与男性发生性关系或自认为是同性恋或双性恋的男性)的比率很高 HPV感染和HPV相关疾病，包括肛门癌。建议对性行为患者接种HPV疫苗 26岁以下的少数族裔男性，但在18-26岁的青年男性中，接种过HPV疫苗的不到21% 只有不到10%的人接受了所有三种建议剂量(即完成)。致信地址 本期，我们最近开发了一种理论上知情的移动健康HPV疫苗并进行了中试 对YSMM(OutSmart HPV)的干预。据我们所知，OutSmart HPV是第一个HPV疫苗干预 是为这群人开发的。初步研究确定了干预的可行性和可接受性，并 产生了非常有希望的初步数据。然而，这项研究的试验性性质使我们无法正式 建立干预效果或检查额外的干预机制过程。 拟议的研究是这一研究方向的关键的下一步，因为它将建立在我们的初步研究的基础上，以 通过一项功能强大的随机对照试验全面评估OutSmart HPV。我们将在1995年招募 来自美国的18-25岁未接种疫苗的YSMM通过社交媒体随机选择每个参与者：a) 通过移动友好网站提供有关HPV和HPV疫苗的标准信息(控制组)；b)OutSmart 具有单向疫苗提醒的HPV；或c)具有交互式疫苗提醒的智能HPV。目标1将 确定OutSmart HPV在增加HPV疫苗启动率和完成率方面的有效性。在这样做的时候， AIM将确定哪种类型的HPV疫苗提醒(单向或交互式)最有效 作为OutSmart HPV干预的一部分，增加疫苗接种。目标2将确定调解人来解释 研究ARM与HPV疫苗启动和完成的关系。这将通过以下方式识别该机制 哪些干预措施影响HPV疫苗接种(即干预措施如何导致理论上的变化 这反过来又导致接种疫苗)。目标3将确定不同关键因素的干预效果是否不同 参与者与人口和健康有关的特征(即适度)。这将使我们能够确定 如果智慧型HPV在不同的亚组中有不同的疗效，如果是这样的话，识别哪些男性 未来的干预可能需要进一步的适应。拟议的研究结果将提供证据 关于干预效果、调解人和调解人的基础。这些发现将提供一个复杂的 了解OutSmart HPV，这是有效和高效地传播这一创新产品所必需的 未来对基督教青年会的干预。

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.