Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care

背景资料。暴露前预防(PrEP)极大地改变了预防艾滋病毒的承诺， 尤其是男同性恋者、双性恋者和其他与男性发生性关系的男性(MSM)，他们占大多数 美国的艾滋病毒感染。因此，PrEP在充分遵守的情况下将艾滋病毒感染减少了90%。 然而，许多MSM在启动、坚持和保持PrEP方面面临着多重挑战， 对特定MSM亚群的特殊挑战，特别是那些经历多重心理社会的人 问题--也称为综合症--包括抑郁；酗酒；多药使用； 精神创伤或虐待；目前的人际暴力；以及作为一名种族/少数民族MSM。初步 研究。生活步骤--一种基于认知行为疗法的干预--成功地支持了ART 在各种研究中坚持治疗和预防。在NIMH R34的资助下，我们改编了生活- 步骤干预以支持MSM遵守PrEP，并进行了两臂试点RCT，显示高 参与者的可接受性、实施的可行性和对坚持《PrEP的生命步骤》的承诺 干预。概念模型。目前的研究是为了测试阶梯式护理“适应性”生活的有效性-- 对HIV感染高危男男性行为者实施PrEP依从性干预步骤。阶梯式护理是一种医疗保健 一种交付模式，在该模型中，首先交付干预的资源密集度最低的部分，并且仅 那些继续存在问题的人将接受更高强度、更多资源密集型的干预。 概念模型基于我们的形成性工作，这些工作导致了理论驱动的 干预课程(“PrEP的生活步骤”)，立足于男男性接触者的社会和背景现实 多种心理社会问题是艾滋病毒感染的高危因素。干预概述。我们的干预 从每日双向短信开始，旨在通过提醒增强最佳PrEP遵从性。虽然 对于许多MSM(来自已发表的研究的~2/3)来说，单靠短信不足以克服 遵守PrEP的障碍。那些没有遵守短信提醒的人(在7天内服用4粒)，将 接受生活步骤依从性咨询。研究计划。250名未感染HIV的PrEP幼稚男男性接触者(在 至少50%的种族/少数民族)有遵守困难的风险(≥1综合征)将在#年招募 两个美国主要城市，都有很好的接触人口和研究经验的机会。参与者将是 同样随机分为：(1)《生命--PrEP的步骤》--分级护理、坚持治疗和综合干预 技术与咨询；(2)护理标准对照组。参与者将被跟踪18个月 后随机化。主要结果是增强了PrEP遵从性(DBS TFV-DP 浓度和自我报告)和保留在PrEP护理中；我们还将检查PrEP的改进 坚持技能和无避孕套的肛交行为不受PrEP保护。最后，经济影响 考虑到医疗保健部门和社会福利将与护理标准进行比较。

Background. Pre-exposure prophylaxis (PrEP) has dramatically changed the promise of HIV prevention, particularly for gay, bisexual, and other men who have sex with men (MSM) who account for the majority of HIV infections in the U.S. Accordingly, PrEP reduces HIV acquisition by >90% with adequate adherence. However, many MSM face multiple challenges with respect to initiating, adhering to, and staying on PrEP, with particular challenges for specific MSM subgroups, specifically those experiencing multiple psychosocial problems—also known as syndemics—including depression; heavy alcohol use; polydrug use; history of trauma or abuse; current interpersonal violence; as well as being a racial/ethnic minority MSM. Preliminary Research. Life-Steps—a cognitive-behavioral therapy-based intervention—has successfully supported ART treatment and prevention adherence in various studies. With funding from an NIMH R34, we adapted the Life- Steps intervention to support PrEP adherence for MSM and conducted a 2-arm pilot RCT that showed high participant acceptability, feasibility of implementation, and promise of the “Life-Steps for PrEP” adherence intervention. Conceptual Model. The current study is to test the efficacy of a stepped-care “adaptive” Life- Steps for PrEP adherence intervention for MSM at high-risk for HIV acquisition. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who continue to have problems receive the higher intensity, more resource intensive parts of an intervention. The conceptual model is based on our formative work that led to the development of a theoretically-driven intervention curriculum (“Life-Steps for PrEP”), grounded in the social and contextual realities of MSM with multiple psychosocial problems at high-risk for HIV acquisition. Overview of Intervention. Our intervention begins with 2-way daily text messaging aimed at enhancing optimal PrEP adherence via reminders. Although helpful, for many MSM (~2/3 from published research), text messaging alone is not sufficient to overcome the barriers to PrEP adherence. Those not adherent (<4 pills over a 7-day period) from text reminders, will “step up” to receive Life-Steps adherence counseling. Research Plan. 250 HIV uninfected PrEP naïve MSM (at least 50% racial/ethnic minority) at risk for adherence difficulties (≥1 syndemic condition) will be recruited in two major U.S. cities with excellent access to and research experience with the population. Participants will be equally randomized to: (1) “Life-Steps for PrEP” – a stepped care, adherence intervention with integrated technology and counseling; or (2) Standard of care control group. Participants will be followed for 18-months post-randomization. The primary outcomes are enhanced maintenance of PrEP adherence (DBS TFV-DP concentrations & self-report) and retention in PrEP care; we will also examine improvements in PrEP adherence skills and condomless anal sex acts not protected by PrEP. Lastly, the economic impact considering healthcare sector and societal benefits will be calculated compared to standard of care.