Division of Adolescent Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E. Chicago Avenue, Box 161, Chicago, IL, 60611, USA.
Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
BMC Public Health. 2020 Jan 15;20(1):65. doi: 10.1186/s12889-020-8180-4.
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.
背景：美国年轻的性少数群体男性感染 HIV 的发病率很高。在这个群体中进行早期干预，即在性开始之前或同时进行干预，对于预防 HIV 感染至关重要。尽管如此，针对不同种族/民族、非常年轻、性少数群体男性（年龄≤18 岁）的降低 HIV 获得风险的干预措施，很少有发表的随机对照疗效试验。本文描述了一项基于移动应用程序的干预试验的设计，以降低该群体的性风险并促进健康保护。
方法：这是一项针对不同性少数群体顺性别年轻男性（年龄 13-18 岁）的基于 mHealth 的 HIV 预防干预措施 MyPEEPS Mobile 的随机对照试验。该移动干预措施改编自先前具有疗效的基于小组的干预课程，旨在针对年轻性少数群体男性的风险背景和现实情况进行具体设计，并包括心理教育和技能建设组件，以及具有互动游戏和活动的内容。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、纽约市、华盛顿州西雅图）和全国范围内通过互联网招募，亲自或远程（通过视频会议）注册，并按 1:1 的比例随机分配到 MyPEEPS Mobile 干预组或延迟干预组。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性伴侣数量和与男性性伴侣进行性行为的频率（有无避孕套）、在物质影响下发生性行为以及接受暴露前和暴露后预防措施的情况，以及在 3、6 和 9 个月随访时进行 HIV 和其他性传播感染的检测。
讨论：需要为非常年轻的性少数群体男性提供行为干预措施，以在他们的性发育和成熟早期预防性行为风险。这项研究将提供证据，以确定一种基于移动应用程序的 HIV 预防干预措施在减少这个非常年轻群体的性风险方面的可行性和有效性。
试验注册：ClinicalTrials.gov 编号，NCT03167606，于 2017 年 5 月 30 日注册。
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