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.

摘要 在美国，大多数（约70%）年度新诊断的艾滋病毒感染者是使用药物的性少数群体 顺性别男性（MSM）和性别少数的跨性别女性（TW）。1 TW/MSM更有可能报告或 被诊断患有物质使用障碍（SUD）的人比他们的顺性别或异性恋对手多2 -5， SUD的存在大大增加了两组中艾滋病毒感染的风险。6 - 16尽管PrEP高度 有效，启动，坚持和持久性完全是行为结果，生物医学益处 的PrEP被物质使用废除。SUD也与生活质量降低相关， 过量死亡，利用高成本的医疗保健服务，参与街头经济，以及 监禁。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的基础上- PrEP（辅助服务知识-PrEP）试点，利用短信（SMS）进行PrEP导航 支持在TW/MSM中增加PrEP启动。II期研究将实施一项RCT， ASK-PREP与标准治疗（SOC）的治疗设计，以确定最佳干预反应， TW/MSM，SUD（N=285; n=95 TW; n=190 MSM），以便沿着PrEP护理连续体推进。 受试者将被随机（3：1）分配至阶梯式治疗组（n=214）或SOC组（n=71）。阶梯式护理的参与者 手臂将接受与试点研究中相同的ASK-PrEP干预，并将在3- 干预反应的时间为3个月;反应者将维持在ASK-PrEP中，而无反应者将接受 通过应急管理（CM）增加对SUD的关注。无应答者将重新随机（1：1）分配至 a）接受ASK-PrEP + CM，或B）将主要焦点转移到其SUD（仅CM）。ASK-PrEP 导航干预基于推理行动方法的机制，SMS支持基于 社会支持理论，CM是基于行为经济学。具体目标是：1）评估一个步骤 护理方法促进了PrEP护理连续体（启动、坚持、持续）的沿着进展， 2）估计实施的成本， 维持每项干预措施，并进行成本效益分析，以确定每项措施的价值 干预相对于SOC，以及彼此，从卫生保健部门，国家决策者，和社会 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，以及不同的个人水平特征， 结果的调节者;和探索性目标）通过选择的PrEP评估干预参与和反应 方式（每日口服或长效注射）。“意向治疗”RCT使用基线时的重复评估 以及入组后3个月、6个月、9个月和12个月。本研究将在洛杉矶县进行， 27，28这项研究可以通过确定可扩展和有效的公共卫生影响， 匹配强度和参与者需求的PrEP干预措施可以最大限度地提高疗效，同时最大限度地降低成本。