Efficacy of a Trauma Intervention for Affect Regulation, Adherence, and Substance Use to Optimize PrEP for Women Who Inject Drugs

创伤干预对影响调节、依从性和物质使用的功效，以优化注射吸毒女性的 PrEP

• 批准号: 10425426
• 负责人: Alexis Marie Roth
• 金额: $ 86.52万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10425426
• 关键词: AIDS prevention; Abstinence; Address; Adherence; Adoption; Affect; Behavior Therapy; Behavioral; Caring; Cities; Clinical; Collection; Communities; Cost Effectiveness Analysis; Disease; Disease Outbreaks; Distress; Dose; Economics; Effectiveness; Enrollment; Epidemic; Evidence based intervention; Face; Female; Gender; Geography; Goals; HIV; HIV Infections; HIV risk; Hair; Health; Health Benefit; Health behavior; Injecting drug user; Intervention; Link; Long-Term Effects; Measures; Mediating; Mediation; Mental Depression; Methods; Modeling; Needle Sharing; Needle-Exchange Programs; Opioid; Outcomes Research; Participant; Pathway interactions; Pharmaceutical Preparations; Pharmacotherapy; Phase; Philadelphia; Population; Prevention; Prevention strategy; Public Health; Randomized; Randomized Controlled Trials; Regulation; Reporting; Research; Rewards; Risk; Risk Behaviors; Running; Scalp structure; Severities; Signal Transduction; Sterility; Stimulant; Symptoms; Syringes; Tenofovir; TimeLine; Trauma; Treatment Effectiveness; Unsafe Sex; Urine; Ursidae Family; Viral Load result; Woman; Work; Writing; attentional control; base; cocaine use; cohort; condoms; contingency management; cost effectiveness; efficacy testing; essays; experience; expressive writing; financial incentive; follow up assessment; improved; innovation; interest; intervention effect; novel; pre-exposure prophylaxis; primary outcome; programs; psychological symptom; reduced substance use; scale up; screening; secondary outcome; service programs; sex; showing emotion; stimulant use; substance use; tool; trauma symptom; two-arm study; uptake; violence exposure; virtual

PROJECT SUMMARY/ ABSTRACT Women who inject drugs (WWID), especially those engaging in sex work, bear a disproportionate burden of new HIV infections. While WWID would benefit from woman-controlled HIV prevention strategies, such as pre- exposure prophylaxis (PrEP), they have been underrepresented in all phases of PrEP research and uptake remains low. The goal of this randomized controlled trial (RCT) is to test the efficacy of a trauma-informed expressive writing (EW) intervention for boosting the effectiveness of contingency management (CM) to reduce HIV acquisition risk in WWID who initiate pre-exposure prophylaxis (PrEP). The rationale is that EW+CM will address the intersection of trauma, substance use, and suboptimal PrEP adherence to achieve more durable reductions in HIV acquisition risk (i.e., the co-occurrence of HIV risk behaviors and PrEP non-adherence). This RCT will leverage our longstanding partnership with Prevention Point Philadelphia. WWID who are at risk for HIV (e.g., report syringe sharing or condomless sex and no PrEP use within 30 days) and interested in PrEP will be linked to PrEP care at Prevention Point. A cohort of 360 WWID who initiate PrEP will be enrolled and immediately begin a 3-month CM period that includes daily directly observed PrEP doses, stimulant/opioid abstinence (measured thrice weekly through urine screening), and 4 writing sessions. After a run-in period, women will be randomized to one of two study arms: EW+CM (n=180) or Neutral Writing+CM (n=180). Follow- up assessments will be conducted at 3, 6, and 12 months post-randomization and will include collection of scalp hair to quantify monthly levels of tenofovir, an objective metric of PrEP adherence. The specific aims of this RCT are to: (1) Determine the efficacy of EW+CM for improving the proportion of participants achieving reductions in HIV acquisition risk (operationalized as the proportion of WWID reporting syringe sharing or condomless sex during objectively measured periods of PrEP non-adherence) at 12 months. (2) Examine key secondary outcomes such as greater PrEP persistence, reductions in substance use, PTSD symptoms, depression, entry into drug treatment, and cost-effectiveness over 12 months. (3) Evaluate mediating pathways through which the intervention operates (e.g., mediated by reductions in substance use or emotional expression and processing in EW essays) and moderators of these relationships (e.g., more pronounced among those with higher PTSD severity at baseline). This RCT could have exceptional impact by yielding one of the first evidence-based interventions to address HIV acquisition risk in the era of PrEP among WWID. It is highly innovative to integrate this gender-specific RCT into known and needed community-based SSP services and to include a robust cost-effectiveness analysis to guide implementation and scale up should EW+CM be efficacious. The long-term outcome of this research program will be a reduction in HIV through a replicable model that that optimizes PrEP engagement among WWID.

项目摘要/摘要 注射毒品（WWID），尤其是从事性工作的妇女，承担不成比例的负担 新的艾滋病毒感染。尽管WWID将从女性控制的HIV预防策略中受益，例如 预防暴露（PREP），在准备和吸收的所有阶段中，它们的代表性不足 保持低。这项随机对照试验（RCT）的目的是测试受创伤信息的功效 表达式写作（EW）干预措施提高应急管理（CM）的有效性以减少 启动预防前预防的WWID的HIV获取风险（PREP）。理由是ew+cm将 解决创伤，物质使用和次优的准备依从性的交点以实现更耐用的 艾滋病毒获取风险的减少（即，艾滋病毒风险行为的同时出现和不依从性）。这 RCT将利用我们与预防点费城的长期合作关系。 WWID有风险 艾滋病毒（例如，报告注射器共享或无避孕套性别，在30天内不使用PREP），并且对PREP感兴趣 将与预防点的预备护理联系起来。启动PREP的360个队列将被注册，并且 立即开始一个3个月的CM时期，包括每日直接观察到的准备剂量，刺激性/阿片类药物 禁欲（通过尿液筛查每周三次测量）和4次写作课程。经过磨合期， 妇女将被随机分为两个研究臂之一：EW+CM（n = 180）或中性写作+CM（n = 180）。跟随- 随机化后3、6和12个月将进行UP评估，并将包括收集 头皮头发可量化每月的替诺福韦水平，这是预遵循的客观指标。具体目的 此RCT的旨在：（1）确定EW+CM提高参与者所取得的比例的功效 减少艾滋病毒收购风险（以WWID报告注射器共享或 在客观测量的不遵守期间的无避孕套性别）12个月时。 （2）检查密钥 次要结果，例如更大的准备持续性，降低药物使用，PTSD症状， 抑郁症，进入药物治疗以及成本效益12个月。 （3）评估中介途径 干预的运作（例如，通过减少药物使用或情感介导的介导 在EW论文中的表达和处理）和这些关系的主持人（例如，更明显 在基线时PTSD严重程度较高的患者中）。这种RCT可能会产生特别的影响 在WWID期间，首先基于证据的干预措施解决了艾滋病毒获取风险。这是 高度创新的，将这种特定性别的RCT集成到已知和需要的社区SSP服务中 并包括强大的成本效益分析以指导实施和扩展，如果是EW+CM 有效。该研究计划的长期结果将是通过可复制的艾滋病毒的减少 模型，可以优化WWID之间的准备工作。