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，每年最多（〜70％）新诊断的艾滋病毒感染是使用性少数群体之一 Sisgender男性（MSM）和性别少数跨性别妇女（TW）。1TW/MSM更有可能报告或成为 诊断出患有药物使用障碍（SUD），而不是其cisgender或异性恋对应物2-5 两组的SUD的存在大大增加了艾滋病毒感染的风险。6-16-16AlagePrEP高度 有效，主动性，遵守和持久性是行为结果，以及生物医学益处 用物质使用废除准备的准备。 SUD还与减少质量有关，并增加 过量的死亡，高成本医疗服务的利用，街头经济的参与以及周期 监禁17-26本申请基于我们开放标签的I阶段A.S.K.-的高度有希望的发现。 PREP（辅助服务知识-PREP）飞行员，该飞行员使用文本消息（SMS）使用准备导航 支持增加TW/MSM之间的准备计划。第二阶段研究将实施带有阶梯的RCT 询问PREP与护理标准（SOC）的护理设计，以确定最佳的干预响应 带有SUD的TW/MSM（n = 285; n = 95 TW; n = 190 msm），以沿PrEP CARE连续体进行进步。 参与者将被随机分配（3：1）以阶梯式护理（n = 214）或SOC（n = 71）。阶梯护理的参与者 ARM将获得与试点研究中交付的相同的ASK-PREP干预措施，并将在3-中进行评估 干预响应的月份；响应者将在Ask-Prep中保持 通过应急管理（CM）增加了对SUD的关注。非响应者将被重新转换为（1：1） a）接收ask-prep + cm，或b）将主要重点转移到其SUD（单独使用CM）。问答 导航干预是基于理性行动方法的机制，SMS支持基于 社会支持理论，CM基于行为经济学。具体目的是：1）评估一个阶梯 护理方法促进沿预备护理连续体（启动，依从性，持久性）的进步， 与SUD的TW/MSM之间的物质使用减少； 2）估计实施成本和 维持每种干预措施并进行成本效益分析以确定每种的价值 与医疗保健部门，国家 - 政治家和社会相对于SOC和彼此的干预措施 观点；次要目的1）确定特定物质，给药途径的各个影响， SUD的严重性，社会和结构性决定者的健康以及将个体水平的特征区分为 结果的主持人；和探索目的）评估选定的准备的干预参与和响应 模态（每天或长效注射）。 “意图对待” RCT在基线时使用重复的评估 并在入学后3，6，9和12个月。该研究将在洛杉矶县进行 优先县。27，28这项研究可以通过确定可扩展有效的方式产生重大公共卫生影响 匹配强度和参与的准备干预措施需要最大程度地提高效率，同时最大程度地减少成本。