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: 10301833
• 负责人: Alexis Marie Roth
• 金额: $ 72.68万
• 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/10301833
• 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; Structure; 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.

项目概要/摘要 注射毒品（WWID）的女性，尤其是从事性工作的女性，承受着不成比例的负担 新的艾滋病毒感染。虽然 WWID 将受益于妇女控制的艾滋病毒预防策略，例如预 暴露预防（PrEP），他们在 PrEP 研究和采用的所有阶段都代表性不足 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）干预可提高应急管理（CM）的有效性，以减少 开始暴露前预防 (PrEP) 的 WWID 存在感染 HIV 的风险。理由是 EW+CM 将 解决创伤、药物滥用和次优 PrEP 依从性的交叉问题，以实现更持久的效果 降低艾滋病毒感染风险（即艾滋病毒风险行为和不遵守 PrEP 的同时发生）。这 RCT 将利用我们与费城预防点的长期合作伙伴关系。有 WWID 风险的人 HIV（例如报告共用注射器或无套性行为以及 30 天内未使用 PrEP）并对 PrEP 感兴趣 将与预防点的 PrEP 护理联系起来。将登记启动 PrEP 的 360 名 WWID 并 立即开始为期 3 个月的 CM 期，其中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 次写作课程。经过一段磨合期后， 女性将被随机分配到两个研究组之一：EW+CM (n=180) 或中性写作+CM (n=180)。跟随- up 评估将在随机化后 3、6 和 12 个月进行，包括收集 头皮头发来量化替诺福韦的每月水平，这是 PrEP 依从性的客观指标。具体目标 该 RCT 的目的是： (1) 确定 EW+CM 对于提高参与者实现目标的比例的功效 HIV 感染风险的降低（具体化为 WWID 报告注射器共享或 12 个月时客观测量的 PrEP 未遵守期间的无套性行为。 (2)检查密钥 次要结果，例如更高的 PrEP 持久性、物质使用的减少、创伤后应激障碍 (PTSD) 症状、 抑郁症、开始药物治疗以及 12 个月内的成本效益。 (3) 评估中介途径 干预通过其发挥作用（例如，通过减少物质使用或情绪调节来介导） 电子战论文中的表达和处理）以及这些关系的调节者（例如，更明显的 那些基线时 PTSD 严重程度较高的人）。这项随机对照试验可能会产生特殊的影响 WWID 中 PrEP 时代首个解决 HIV 感染风险的循证干预措施。这是 高度创新地将这种针对性别的随机对照试验纳入已知和需要的基于社区的 SSP 服务 并纳入强有力的成本效益分析，以指导 EW+CM 的实施和扩大规模 有效。该研究计划的长期成果将是通过可复制的方法减少艾滋病毒 优化 WWID 之间 PrEP 参与的模型。