Optimizing PrEP Engagement Among Women Who Use Drugs in Tanzania

项目总结 使用毒品，特别是海洛因的妇女在艾滋病毒流行中背负着不成比例的负担。 在坦桑尼亚。尽管在艾滋病毒预防方面取得了进展，但生物医学干预措施，包括暴露前预防 (PREP)，PrEP在坦桑尼亚的普及一直很缓慢。精神障碍，包括抑郁、焦虑和后遗症 创伤应激障碍在WWUD中很常见，是艾滋病预防行为的已知障碍， 包括PrEP订婚。在WWUD中，精神健康问题的高流行率可能会被忽视 破坏更多地使用艾滋病毒预防战略的努力，包括预防接种计划，其中包括 脆弱但未被充分研究的人群。动机访谈与认知行为疗法 (CBT)是基于证据的干预措施，已由辅助专业人员成功提供，两者 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 预防疾病，并改善对艾滋病毒预防战略的接受和遵守。共同的元素 治疗方法(CETA)是一种基于CBT的跨诊断干预方法，用于低位和 在中等收入国家，由未接受或仅接受过有限心理健康培训的非专业辅导员接生。这个 本研究的目标是使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准专业人员分娩的干预措施(CETA+MI-PrEP)，以优化PrEP WWUD之间的互动。本研究的具体目的是：(1)确定PrEP的障碍和激励因素 参与度，以及能够最有效地提供MI-PrEP和CETA+MI的辅助专业人员类型- 利用深入访谈和与WWUD、同行和非同行社区的焦点小组进行准备干预 卫生工作者、业馀顾问和心理健康专家，(2)系统地使MI-PrEP和CETA适应于 使用Adapt-ITT模型对坦桑尼亚的WWUD与共生精神障碍进行研究，以及(3)评估 MI-PrEP和CETA+MI-PrEP介入治疗的可行性、保真度和初步疗效 对120例WWUD合并精神障碍症状的试点可行性试验。一种组合 访谈、结构化调查和监督将被用来评估干预的可行性和保真度。 干预的初步效果将根据PrEP参与的主要结果进行评估 以及阿片类药物使用的次要后果，抑郁、焦虑和创伤后应激症状，以及PrEP 动机和障碍。这项试点可行性研究将：(1)增进我们对独特因素的理解 这有助于在WWUD之间开展预防艾滋病预防工作，(2)满足 研究不足，但风险极高的人群，以及(3)导致文化适应和当地适应 MI-PrEP和CETA+MI-PrEP干预措施，可在混合类型I中正式测试有效性- 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.