Optimizing PrEP Implementation and Cost-effectiveness among Sexual and Gender Minority Individuals with a Substance Use Disorder

优化患有药物滥用障碍的性少数群体的 PrEP 实施和成本效益

• 批准号: 10525750
• 负责人: Sean M. Murphy
• 金额: $ 59.43万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10525750
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Adherence; Age; Attention; Behavior Therapy; Caring; Characteristics; Client; Continuity of Patient Care; Cost Effectiveness Analysis; County; Diagnosis; Effectiveness; Effectiveness of Interventions; Enrollment; Epidemic; Food; Gender; Gender Identity; Goals; HIV; HIV Infections; HIV Seronegativity; Health; Health Care Costs; Health Care Sector; Heterosexuals; Housing; Imprisonment; Incidence; Individual; Injectable; Injections; Insurance; Intervention; Knowledge; Lead; Legal; Los Angeles; Methamphetamine; Minority; Minority Groups; Minority Women; Modality; Modeling; Newly Diagnosed; Opioid; Oral; Outcome; Participant; Phase; Pilot Projects; Population; Poverty; Prevalence; Productivity; Public Health; Quality of life; Quality-Adjusted Life Years; Randomized; Reduce health disparities; Reporting; Resources; Risk; Route; Services; Severities; Sexual and Gender Minorities; Social support; State Interests; Stimulant; Substance Use Disorder; System; Text Messaging; Time; United States National Institutes of Health; acceptability and feasibility; arm; base; behavioral economics; behavioral outcome; cis-male; cisgender; contingency management; cost; cost effective intervention; cost effectiveness; cost estimate; design; ethnic identity; experience; gender minority; gender minority group; health disparity; health economics; implementation cost; improve minority health; open label; overdose death; phase 2 study; population health; pre-exposure prophylaxis; racial and ethnic; recruit; reduced substance use; response; safety net; service engagement; sexual minority; social structure; standard of care; substance use; texting support; theories; transgender women; truvada

Abstract In the US most (~70%) annual newly diagnosed HIV infections are among substance-using sexual minority cisgender men (MSM) and gender minority transgender women (TW).1 TW/MSM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts2-5 and the presence of a SUD substantially increases risk of HIV infection in both groups.6-16Although PrEP is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes, and the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration.17-26 This application builds upon the highly promising findings from our open-label Phase I A.S.K.- PrEP (Assistance Services Knowledge-PrEP) pilot, which utilized PrEP navigation with text message (SMS) support to increase PrEP initiation among TW/MSM. The Phase II study will implement a RCT with a Stepped Care design of ASK-PREP vs. standard of care (SOC) to determine optimal intervention response among TW/MSM with a SUD (N=285; n=95 TW; n=190 MSM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n=214) or SOC (n=71). Participants in the Stepped Care arm will receive the same ASK-PrEP intervention that was delivered in the pilot study and will be assessed at 3- months for intervention response; responders will be maintained in ASK-PrEP, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone). The ASK-PrEP navigation intervention is based on mechanisms of the Reasoned Action Approach, SMS support is based in Social Support Theory, and CM is based on behavioral economics. The specific aims are to: 1) Evaluate a Stepped Care approach promoting advancement along the PrEP Care Continuum (initiation, adherence, persistence), and reductions in substance use among TW/MSM with a SUD; 2) Estimate the cost of implementing and sustaining each intervention and conduct a cost-effectiveness analysis to determine the value of each intervention relative to SOC, and to each other, from the healthcare-sector, state-policymaker, and societal perspectives; Secondary Aim 1) Determine the individual effects of specific substances, routes of administration, severity of SUD, social and structural determinants of health, and differing individual-level characteristics as moderators of outcomes; and Exploratory Aim) Evaluate intervention engagement and response by chosen PrEP modality (oral daily or long-acting injectable). The “intent-to-treat” RCT uses repeated assessments at baseline and at 3-, 6-, 9-, and 12-months post enrollment. The study will be conducted in Los Angeles County, an EHE priority County.27, 28 This study could have significant public health impact by identifying scalable and effective PrEP interventions that match intensity and participant needs to maximize efficacy while minimizing costs.

抽象的 在美国，每年新诊断的艾滋病毒感染者中，大多数（约 70%）是使用药物的性少数群体 顺性别男性 (MSM) 和性别少数跨性别女性 (TW)。1 TW/MSM 更有可能报告或被 被诊断出患有物质使用障碍 (SUD) 的人比同性或异性恋者2-5 以及 SUD 的存在大大增加了两组人群感染 HIV 的风险。6-16尽管 PrEP 的风险很高 有效、启动、坚持和坚持完全是行为结果，而生物医学益处 PrEP 的效果因物质使用而被废除。 SUD 还与生活质量下降和增加 过量死亡、使用高成本医疗服务、参与街头经济以及循环 incarceration.17-26 该应用程序建立在我们开放标签第一阶段 A.S.K. 的非常有希望的发现之上 - PrEP（援助服务知识-PrEP）试点，利用短信 (SMS) 进行 PrEP 导航 支持增加 TW/MSM 中 PrEP 的启动。 II 期研究将实施一项随机对照试验（Stepped） ASK-PREP 护理设计与护理标准 (SOC) 的比较，以确定最佳干预反应 TW/MSM 与 SUD（N=285；n=95 TW；n=190 MSM），以沿着 PrEP 护理连续体前进。 参与者将被随机 (3:1) 分配至分级护理 (n=214) 或 SOC (n=71)。阶梯护理的参与者 手臂将接受与试点研究中提供的相同的 ASK-PrEP 干预措施，并将在 3- 干预反应几个月；有反应者将保留在 ASK-PrEP 中，无反应者将接受 通过应急管理 (CM) 增加对其 SUD 的关注。无应答者将被重新随机分组 (1:1) 至 a) 接受 ASK-PrEP + CM，或 b) 将主要焦点转移到 SUD（仅 CM）。 ASK-PrEP 导航干预基于理性行动方法的机制，短信支持基于 社会支持理论和CM 基于行为经济学。具体目标是： 1) 评估阶梯式 促进 PrEP 护理连续体（启动、坚持、坚持）进步的护理方法， 并通过 SUD 减少 TW/MSM 的物质使用； 2) 估算实施成本和 维持每项干预措施并进行成本效益分析以确定每项干预措施的价值 医疗保健部门、国家政策制定者和社会团体对 SOC 以及彼此之间的干预 观点；次要目标 1) 确定特定物质的个体效应、给药途径、 SUD 的严重程度、健康的社会和结构决定因素以及不同的个人层面特征 结果的调节者；和探索性目标）评估所选 PrEP 的干预参与度和反应 方式（每日口服或长效注射剂）。 “意向治疗”随机对照试验使用基线重复评估 以及注册后 3、6、9 和 12 个月。该研究将在洛杉矶县进行，这是一个 EHE 优先县.27, 28 这项研究可以通过确定可扩展和有效的方法来产生重大的公共卫生影响 PrEP 干预措施应符合强度和参与者的需求，以最大限度地提高疗效，同时最大限度地降低成本。