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: 10614581
• 负责人: Alexis Marie Roth
• 金额: $ 90.44万
• 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/10614581
• 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 Benefit; Health behavior; Inequity; 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; Risk Reduction; Running; Scalp structure; Severities; Signal Transduction; Sterility; Stimulant; Symptoms; Syringes; Tenofovir; Trauma; Treatment Effectiveness; Unsafe Sex; Urine; Viral Load result; Woman; Work; Writing; acceptability and feasibility; attentional control; cocaine use; cohort; condoms; contingency management; cost effectiveness; efficacy evaluation; 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; timeline; 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.

项目总结/摘要 注射毒品的妇女，特别是从事性工作的妇女， 新的艾滋病毒感染。虽然妇女参与发展将受益于妇女控制的艾滋病毒预防战略，如预防艾滋病毒感染前的预防战略， 暴露预防（PrEP），他们在PrEP研究和吸收的所有阶段都代表不足 仍然很低。这项随机对照试验（RCT）的目的是测试创伤知情的疗效。 表达性写作（EW）干预，以提高应急管理（CM）的有效性， 启动暴露前预防（PrEP）的WWID中的HIV感染风险。理由是EW+CM将 解决创伤，物质使用和次优PrEP依从性的交叉问题，以实现更持久的 降低艾滋病毒感染风险（即，艾滋病毒风险行为和PrEP不依从性的共同发生）。这 RCT将利用我们与费城预防点的长期合作关系。有风险的WWID HIV（例如，报告注射器共享或无避孕套的性行为，并且在30天内没有使用PrEP）并对PrEP感兴趣 将与预防点的PrEP护理联系起来。将招募360名启动PrEP的WWID队列， 立即开始为期3个月的CM期，包括每日直接观察的PrEP剂量、兴奋剂/阿片类药物 禁欲（通过尿液筛查每周测量三次）和4次写作。经过一段时间的磨合， 女性将被随机分配到两个研究组之一：EW+CM（n=180）或中性书写+CM（n=180）。关注- 将在随机化后3、6和12个月进行向上评估，包括收集 头皮头发定量泰诺福韦每月水平，这是PrEP依从性的客观指标。的具体目标 本RCT旨在：（1）确定EW+CM在提高参与者达到以下目标的比例方面的疗效 降低艾滋病毒感染风险（可操作为WWID报告共用注射器的比例，或 在客观测量的PrEP非依从性期间的无避孕套性行为）。(2)验匙 次要结果，如更大的PrEP持续性，减少物质使用，PTSD症状， 抑郁症，进入药物治疗，以及12个月的成本效益。(3)评估介导途径 干预通过其操作（例如，通过减少物质使用或情绪 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）。这项随机对照试验可能会产生特殊的影响， 第一个基于证据的干预措施，以解决艾滋病毒感染风险的时代，准备在WWID。是 将这种针对性别的随机对照试验纳入已知和所需的社区SSP服务，具有高度创新性 并包括一个强大的成本效益分析，以指导实施和规模扩大，如果EW+CM是 灵验。这项研究计划的长期成果将是通过一种可复制的方法减少艾滋病毒感染。 该模型优化了WWID之间的PrEP参与。