Optimizing PrEP Engagement Among Women Who Use Drugs in Tanzania

项目摘要 吸毒妇女，特别是海洛因吸毒妇女，在艾滋病毒流行病中承担了不成比例的负担 在坦桑尼亚。尽管在艾滋病毒预防方面取得了进展， （PrEP），坦桑尼亚的PrEP吸收缓慢。精神障碍，包括抑郁症、焦虑症和产后抑郁症。 创伤应激障碍，在WWUD中很高，是艾滋病毒预防行为的已知障碍， 包括PrEP参与。对WWUD中精神健康问题的高患病率的忽视， 破坏增加使用艾滋病毒预防战略的努力，其中包括PrEP， 脆弱但未被充分研究的人群动机访谈与认知行为治疗 (CBT)是由准专业人员成功提供的循证干预措施， 在全球和坦桑尼亚，针对一系列健康状况，包括药物使用障碍和精神疾病， 这些措施旨在提高对艾滋病毒预防战略的接受和遵守。的共同要素 治疗方法（CETA）是一种跨诊断的、基于CBT的干预措施，用于低水平和高水平的癌症患者。 中等收入国家，由没有受过或受过有限心理健康培训的非专业顾问提供服务。的 本研究的目的是使MI适应PrEP参与（MI-PrEP）以及CETA和MI-PrEP的组合 坦桑尼亚达累斯萨拉姆的准专业人员提供的干预措施（CETA+MI-PrEP），以优化PrEP 在WWUD中的参与。本研究的具体目的是：（1）识别PrEP的障碍和动机 参与，以及能够最有效地提供MI-PrEP和CETA+MI的准专业人员类型- PrEP干预措施，使用深入访谈和焦点小组与WWUD，同行和非同行社区 卫生工作者，非专业顾问和心理健康专家，（2）系统地调整MI-PrEP和CETA， 使用ADAPT-ITT模型评估坦桑尼亚WWUD与共发精神障碍的关系，以及（3）评估 三组研究中MI-PrEP和CETA+MI-PrEP干预的可行性、保真度和初步疗效 对120名有精神障碍并发症的WWUD进行试点可行性试验。的组合 访谈、结构化调查和监督将用于评估干预的可行性和忠实性。 将针对PrEP参与的主要结局估计干预措施的初步疗效 阿片类药物使用的次要结局，抑郁、焦虑和创伤后应激的症状，以及PrEP 动机和障碍。这项试点可行性研究将：（1）促进我们对独特因素的理解 （2）满足艾滋病毒预防需求， 研究不足，但极高风险的人群，（3）导致文化上适当和当地适应 MI-PrEP和CETA+MI-PrEP干预措施可以在混合I型有效性中进行正式测试- 实施随机对照试验。

PROJECT SUMMARY Women who use drugs (WWUD), specifically heroin, shoulder a disproportionate burden of the HIV epidemic in Tanzania. Despite advances in HIV prevention biomedical interventions, including pre-exposure prophylaxis (PrEP), PrEP uptake has been slow in Tanzania. Mental disorders, including depression, anxiety, and post- traumatic stress disorder, are high among WWUD and are known barriers to HIV prevention behaviors, including PrEP engagement. Inattention to the high prevalence of mental health problems in WWUD, is likely to undermine efforts to increase the use of HIV prevention strategies, including PrEP, among this highly vulnerable, yet understudied population. Motivational interviewing (MI) and cognitive-behavioral therapy (CBT) are evidence-based interventions that have been successfully delivered by paraprofessionals, both globally and in Tanzania, for a range of health conditions, including substance use disorders and mental disorders, and to improve uptake and adherence of HIV prevention strategies. The Common Elements Treatment Approach (CETA) is a transdiagnostic, CBT-based intervention developed for use in low- and middle-income countries for delivery by lay counselors with no or limited previous mental health training. The goal of this study is to adapt MI for PrEP engagement (MI-PrEP) and a combined CETA and MI-PrEP interventions (CETA+MI-PrEP) for delivery by paraprofessionals in Dar es Salaam, Tanzania, to optimize PrEP engagement among WWUD. The specific aims of this study are to: (1) identify barriers and motivators to PrEP engagement, and the types of paraprofessionals who could most effectively deliver the MI-PrEP and CETA+MI- PrEP interventions using in-depth interviews and focus groups with WWUD, peer- and non-peer community health workers, lay counselors, and mental health specialists, (2) systematically adapt MI-PrEP and CETA for WWUD with co-occurring mental disorders in Tanzania using the ADAPT-ITT model, and (3) assess the feasibility, fidelity, and preliminary efficacy of the MI-PrEP and CETA+MI-PrEP interventions in a three-arm pilot feasibility trial with 120 WWUD with co-occurring symptoms of mental disorders. A combination of interviews, structured surveys, and supervision will be used to assess for intervention feasibility and fidelity. The preliminary efficacy of the intervention will be estimated for the primary outcomes of PrEP engagement and secondary outcomes of opioid use, symptoms of depressive, anxiety, and post-traumatic stress, and PrEP motivation and barriers. This pilot feasibility study will: (1) advance our understanding of the unique factors that contribute to the PrEP engagement among WWUD, (2) address the HIV prevention needs of an understudied, yet extremely high-risk population, and (3) result in culturally appropriate and locally adapted MI-PrEP and CETA+MI-PrEP interventions that can be formally tested in a Hybrid Type I Effectiveness- Implementation randomized controlled trial.