BACKGROUND Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group. METHODS This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up. DISCUSSION Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group. TRIAL REGISTRATION ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.

中文翻译：

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针对性少数年轻男性的 mHealth HIV 预防干预的随机对照疗效试验：MyPEEPS 移动研究方案。


背景技术美国年轻性少数男性的HIV感染率很高。对这一群体进行早期干预，即在性行为开始之前或同时进行，对于预防艾滋病毒感染至关重要。尽管如此，很少有已发表的随机对照功效试验测试干预措施，以降低种族/民族多样化、非常年轻的性少数男性（年龄≤18岁）感染艾滋病毒的性脆弱性。本文介绍了一项基于移动应用程序的干预试验的设计，以降低感染艾滋病毒的性风险并促进该群体的健康保护。方法 本研究是一项基于移动医疗的 HIV 预防干预措施 MyPEEPS Mobile 的随机对照试验，研究对象为 13-18 岁的不同性少数顺性别年轻男性。移动干预改编自先前基于团体的干预课程，具有有效性证据，旨在针对年轻性少数男性的风险背景和现实，并包括心理教育和技能建设部分以及互动游戏和活动。参与者在四个区域中心（阿拉巴马州伯明翰、伊利诺伊州芝加哥、纽约州纽约市、华盛顿州西雅图）本地招募，并通过互联网在全国范围内招募，亲自或远程（通过视频会议）报名，并随机（1:1） ) 到 MyPEEPS Mobile 干预或延迟干预条件。根据年龄、种族/民族以及城市/郊区与农村状况进行事后分层，以确保样本的多样性。 主要结果是男性肛交伴侣的数量和与男性伴侣发生性行为的频率（带或不带避孕套）、物质影响下的性行为、暴露前和暴露后预防措施的采用情况以及艾滋病毒和艾滋病病毒检测。 3、6 和 9 个月随访时的其他性传播感染。讨论 需要对非常年轻的性少数男性进行行为干预，以预防其性发育和成熟早期的性风险。这项研究将提供证据来确定基于移动应用程序的艾滋病毒预防干预措施的可行性和有效性，以降低这个非常年轻的群体的性风险。试验注册 ClinicalTrials.gov 编号，NCT03167606，注册于 2017 年 5 月 30 日。