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

评估提高 PrEP 护理依从性和参与度的生活步骤

• 批准号: 10009463
• 负责人: KENNETH H MAYER
• 金额: $ 76.2万
• 依托单位: UNIVERSITY OF MIAMI CORAL GABLES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-06 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009463
• 关键词: AIDS prevention; Adherence; Affect; African American; Anti-Retroviral Agents; Behavior Therapy; Bisexual; Boston; Caring; Cities; Cognitive Therapy; Control Groups; Counseling; Data; Development; Diphosphates; District of Columbia; Dose; Educational Curriculum; Evaluation; Face; Funding; Gays; HIV; HIV Infections; Health Care Costs; Health Care Sector; Health Services Accessibility; Heavy Drinking; Hispanics; Incidence; Individual; Infection; Interpersonal Violence; Intervention; Latino; Life; Maintenance; Mediator of activation protein; Medical; Mental Depression; Mental Health; Modeling; Monitor; Moods; National Institute of Mental Health; Nurses; Oral; Participant; Patient Self-Report; Pharmaceutical Preparations; Population; Prevalence; Prevention; Prevention strategy; Procedures; Provider; Publishing; Qualitative Research; Randomized; Recording of previous events; Reporting; Research; Resources; Risk; Risk Factors; Sampling; San Francisco; Schedule; Self Efficacy; Service delivery model; Subgroup; Technology; Tenofovir; Testing; Text; Text Messaging; Trauma; Visit; Work; arm; base; condomless anal sex; coping; cost; cost effective; design; economic impact; efficacy testing; emtricitabine; ethnic minority population; evidence base; experience; follow-up; health service use; high risk; high risk men; housing instability; intimate partner violence; men who have sex with men; pill; pre-exposure prophylaxis; prevent; primary outcome; prospective; psychosocial; racial and ethnic; recruit; secondary outcome; skills; social; social structure; sociodemographic variables; socioeconomics; standard of care; theories; therapy development; tool; transgender women; uptake

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.

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、双性恋和其他男男性行为者 (MSM)，他们占大多数 美国的 HIV 感染 因此，如果坚持充分坚持，PrEP 可以将 HIV 感染率降低 90% 以上。 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 亚群体面临的特殊挑战，特别是那些经历多种社会心理的群体 问题（也称为综合症）包括抑郁症；大量饮酒；多种药物的使用；的历史 创伤或虐待；当前的人际暴力；以及少数种族/族裔 MSM。初步的 研究。 Life-Steps——一种基于认知行为治疗的干预措施——已成功支持 ART 各种研究中治疗和预防的依从性。在 NIMH R34 的资助下，我们调整了 Life- 步骤干预支持 MSM 坚持 PrEP 并进行了 2 组试点随机对照试验，结果显示高 参与者的可接受性、实施的可行性以及“PrEP 生命步骤”遵守的承诺 干涉。概念模型。目前的研究是为了测试分级护理“适应性”生活的功效- 对 HIV 感染高风险 MSM 进行 PrEP 依从干预的步骤。阶梯式护理是一种医疗保健 实施模式中，首先实施干预措施中资源最少的部分，并且仅实施那些 仍然存在问题的人会接受强度更高、资源更密集的干预措施。 该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发展 干预课程（“PrEP 的生活步骤”），以 MSM 的社会和背景现实为基础， 多种心理社会问题是感染艾滋病毒的高风险。干预概述。我们的干预 首先是每日双向短信，旨在通过提醒增强 PrEP 最佳依从性。虽然 对于许多 MSM（已发表的研究中约 2/3）来说，仅靠短信不足以克服这一问题 PrEP 依从性的障碍。那些不遵守短信提醒的人（7 天内服用少于 4 粒药片），将“踩 接受 Life-Steps 依从性咨询。研究计划。250 名未感染 HIV 的 PrEP 未接触过的 MSM（在 至少 50% 的种族/族裔少数群体）将被招募为有遵守困难风险（≥1 种流行病） 美国的两个主要城市都拥有良好的接触人口和研究经验。参加者将是 同样随机分为：(1)“PrEP 的生命步骤”——阶梯式护理、依从性干预与综合治疗 技术和咨询； (2) 标准护理对照组。参与者将被跟踪 18 个月 随机化后。主要结果是增强 PrEP 依从性的维持（DBS TFV-DP 浓度和自我报告）和 PrEP 护理中的保留；我们还将研究 PrEP 的改进 遵守技巧和无套肛交行为不受 PrEP 保护。最后是经济影响 考虑到医疗保健部门和社会效益将根据护理标准进行计算。