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

背景暴露前预防（PrEP）极大地改变了艾滋病毒预防的前景， 特别是对于同性恋，双性恋和其他与男性发生性关系的男性（MSM），他们占大多数， 因此，PrEP在充分遵守的情况下将HIV感染减少了>90%。 然而，许多MSM在启动、坚持和坚持PrEP方面面临多重挑战， 特定MSM亚群的特殊挑战，特别是那些经历多种心理社会问题的人 问题-也称为综合征-包括抑郁症;重度酒精使用;多种药物使用; 创伤或虐待;当前的人际暴力;以及作为少数种族/民族男男性行为者。初步 Research.生活步骤--一种基于认知行为疗法的干预--已成功地支持了ART 治疗和预防依从性的研究。在NIMH R34的资助下，我们改造了生命- 步骤干预，以支持MSM的PrEP依从性，并进行了一项双臂试点RCT， 参与者的可接受性，实施的可行性，以及对“PrEP生命步骤”依从性的承诺 干预概念模型。目前的研究是测试分级护理“适应性”生活的功效， 步骤PrEP依从性干预MSM在艾滋病毒感染的高风险。分级护理是一种医疗保健 一种交付模式，首先交付干预措施中资源密集程度最低的部分，只有那些 继续有问题的人接受更高强度、更资源密集的干预部分。 概念模型是基于我们的形成性工作，导致了理论驱动的发展， 干预课程（“生命步骤的准备”），植根于男男性行为者的社会和背景现实， 多种心理社会问题，艾滋病毒感染的高风险。干预概述。我们的干预 从每天双向短信开始，旨在通过提醒提高最佳PrEP依从性。虽然 对于许多MSM（约2/3来自已发表的研究）来说，短信本身不足以克服 PrEP依从性的障碍。那些不遵守（<4丸超过7天）从文字提醒，将“步骤 ”，并接受了“生命步骤”的坚持咨询。研究计划。250例未感染艾滋病毒的PrEP初治MSM（ 至少50%的种族/少数民族），将在以下人群中招募 两个主要的美国城市，具有良好的访问和研究经验的人口。参与者将被 同样随机分配至：（1）“PrEP的生命步骤”-一种阶梯式护理，依从性干预， 技术和咨询;或（2）护理标准对照组。参与者将被跟踪18个月 随机化后。主要结局是增强PrEP依从性的维持（DBS TFV-DP 浓度和自我报告）和保留PrEP护理;我们还将研究PrEP的改进 坚持技能和无避孕套肛交行为不受PrEP保护。最后， 考虑到医疗保健部门和社会效益，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.