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

项目摘要/摘要 注射毒品的妇女，特别是那些从事性工作的妇女，承担着不成比例的 新的艾滋病毒感染。虽然世界卫生组织将受益于妇女控制的艾滋病毒预防战略，例如 暴露预防(PrEP)，它们在PrEP研究和吸收的所有阶段都没有得到充分的代表 仍然很低。这项随机对照试验(RCT)的目标是测试创伤知情患者的疗效 提高应急管理(CM)有效性的表现性写作(EW)干预 实施暴露前预防(PrEP)的WWID人群中HIV感染的风险。理由是EW+CM将 解决创伤、药物使用和次优PrEP依从性的交叉问题，以实现更持久的效果 减少艾滋病毒感染风险(即艾滋病毒危险行为和不遵守PrEP的共同发生)。这 RCT将利用我们与费城预防中心的长期合作伙伴关系。面临以下风险的WWID 艾滋病毒(例如，报告共用注射器或无避孕套性行为，30天内没有使用PrEP)，并对PrEP感兴趣 将与预防中心的PrEP护理挂钩。发起PrEP的360个WWID队列将被登记，并 立即开始为期3个月的CM周期，包括每日直接观察的PrEP剂量、兴奋剂/阿片类药物 禁欲(通过尿检每周测量三次)，以及4次写作会议。经过一段磨合期后， 女性将被随机分为两组：EW+CM组(n=180)或中性写作+CM组(n=180)。以下为- UP评估将在随机化后3、6和12个月进行，并将包括收集 以量化每月的替诺福韦水平，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对提高参与者实现以下目标的比例的有效性 艾滋病毒感染风险的降低(以WWID报告共用注射器或 在客观测量的PrEP不坚持期间的无避孕套性行为)在12个月。(2)检查关键字 次要结果，如更强的PrEP持久性，药物使用的减少，创伤后应激障碍症状， 抑郁、开始药物治疗和超过12个月的成本效益。(3)评价中介途径 干预通过其进行操作(例如，通过减少物质使用或情感 EW文章中的表达和处理)和这些关系的调节因素(例如，更明显的 在基线时创伤后应激障碍严重程度较高的人中)。这一RCT可能会产生特殊的影响 在世界卫生组织中首次开展循证干预措施，以应对预防接种计划时代的艾滋病毒感染风险。它是 高度创新，将这种针对性别的RCT整合到已知和需要的基于社区的SSP服务中 并包括强大的成本效益分析，以指导实施并在EW+CM 很有效。这项研究计划的长期结果将是通过可复制的 在WWID中优化PrEP参与度的模型。

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.