A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial
A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial
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DOI：
10.2196/10661
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发表时间：
2019-01-01
影响因子：
1.7
通讯作者：
Mayer, Kenneth H.
中科院分区：
文献类型：
--
作者：
Biello, Katie B.;Psaros, Christina;Mayer, Kenneth H.
背景：年轻男男性行为者（YMSM）中HIV新发感染率高得不成比例。因此，必须制定、测试和传播专门针对其需求和观念的全面艾滋病毒预防战略。抗逆转录病毒暴露前预防（PrEP）在减少男男性行为者中的艾滋病毒传播方面是有效的；然而，坚持治疗对其疗效至关重要。在开放标签研究中，YMSM的依从性是次优的。因此，需要采取行为方法来解决YMSM PrEP依从性的独特挑战。目的：本研究旨在描述PrEP依从性干预的改进方案和一项随机对照试验（RCT）， LifeSteps用于年轻男男性行为者暴露前预防（LSPY）。方法：本研究包括以下两个阶段：对大约20名年轻男性和10名关键信息提供者进行形成性定性访谈，以适应和改进干预措施；对多达50名年轻男性进行试点随机对照试验，以评估LSPY与PrEP标准护理相比的可行性、可接受性和初步疗效，以提高PrEP的依从性。参与者将在美国的3个iTech主题招聘场所招募。结果：第一阶段预计将于2018年6月开始，第二阶段预计将于2019年初开始。结论：很少有经过严格开发和测试的干预措施旨在提高社区环境中YMSM的PrEP依从性，尽管这一人群的艾滋病毒感染率很高。这项干预措施的长期目标是制定可扩展的方案，以优化高危男性的PrEP接受和坚持，以降低艾滋病毒发病率。
Background: New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed.Objective: This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY).Methods: This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States.Results: Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019.Conclusions: Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population's high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM's PrEP uptake and adherence to decrease the HIV incidence.