Tu'Washindi: A relationship-focused intervention to reduce GBV and increase PrEP uptake and adherence among Kenyan AGYW

项目总结 这个R01应用程序由一名早期调查员领导，旨在测试多层次社区的有效性- 提高青少年口服暴露前预防(PrEP)摄入量和依从性的基础干预 肯尼亚女孩和年轻妇女(AGYW)。在这种背景下，AGYW生活在性别不平等加剧的背景下 和亲密伴侣暴力(IPV)的风险，并代表了一个特别容易感染艾滋病毒的大亚群 感染。除了有较高的艾滋病毒发病率外，经历IPV的妇女更不可能发起和持续感染 对于PrEP，限制了这种有效的生物医学预防干预的保护效益。PrEP面临的障碍 吸收和坚持发生在社会生态模型的多个层面上，包括低个人自我效能， 合作伙伴的反对，以及社区的污名。我们是PrEP的赢家，是一个多层次的， 专门为应对锡亚县AGYW之间的这些挑战而设计的基于社区的干预措施， 肯尼亚。由我们的团队使用参与式方法设计，参与当地AGYW(R34 MH114519)，干预 包括在6个月内提供的三个部分：为期八节的AGYW赋权支持俱乐部， 针对男性伴侣的社区宣传，以及针对夫妇的PrEP教育活动。活动经过精心设计 纳入以青年为重点的方案编制，以确保效率和可持续性。来自试点集群的结果- 在6个地点进行的100个AGYW的随机对照试验表明，可行性和可接受性很高，以及 初步效果：干预组参与者的PrEP摄取率和依从性提高了2倍(p&lt；0.05)， 与对照组参与者相比，IPV的发生率或严重程度较低。拟议的研究建立在这些有希望的结果的基础上，并 目的是在一项涵盖22个行政病房的完全有效的整群随机对照试验中评估干预 在肯尼亚锡亚县，每个病房招收72名青年儿童(总数为1,584人)。主要目标(目标1)将是测试 产后即刻(产后6个月)对PrEP摄取和依从性的干预效果 注册)和6个月后(12个月)。作为次要目标，我们将测试对IPV和 关系力量(目标2)。严格的流程评估将探索变化的机制、背景因素和 实施注意事项，为未来的改进和扩展提供信息，使用编程数据，参与者 问卷调查和对参与者和提供者的定性访谈(目标3)。建议的研究直接建立在 关于我们的R34干预开发工作，以开发这种由年轻人设计的多水平艾滋病毒的证据基础 预防干预。如果有效，图瓦辛迪将处于可持续融入现有环境的理想位置 以青年为重点的方案拟订工作，以扩大和支持在这一重点人群中使用初级保健方案。

PROJECT SUMMARY This R01 application, led by an Early Stage Investigator, aims to test the effectiveness of a multilevel community- based intervention to increase uptake and adherence to oral pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya. AGYW in this setting live in a context of heightened gender inequality and risk of intimate partner violence (IPV) and represent a large subpopulation who are uniquely vulnerable to HIV infection. In addition to having higher HIV incidence, women experiencing IPV are less likely to initiate and persist with PrEP, limiting the protective benefit of this efficacious biomedical prevention intervention. Barriers to PrEP uptake and adherence occur at multiple levels of the socioecological model, including low individual self-efficacy, partner opposition, and community stigma. Tu'Washindi na PrEP (We are Winners with PrEP) is a multi-level, community-based intervention designed specifically to address these challenges among AGYW in Siaya County, Kenya. Designed by our team using participatory methods engaging local AGYW (R34 MH114519), the intervention includes three components delivered over 6 months: an eight-session, empowerment-based support club for AGYW, community sensitization targeted toward male partners, and PrEP education events for couples. Activities are designed to be integrated into youth-focused programming to ensure efficiency and sustainability. Results from a pilot cluster- randomized controlled trial conducted with 100 AGYW at six sites indicate high feasibility and acceptability, and preliminary effectiveness: intervention arm participants had 2-fold higher PrEP uptake and adherence (p<0.05), with less frequent or severe IPV than control arm participants. The proposed study builds on these promising results and aims to evaluate the intervention in a fully powered cluster-randomized controlled trial across 22 administrative wards in Siaya County, Kenya, enrolling 72 AGYW per ward (total N=1,584). The primary objectives (Aim 1) will be to test the effectiveness of the intervention on PrEP uptake and adherence immediately post-delivery (month 6 post- enrollment) and 6 months later (month 12). As secondary objectives we will test the intervention effect on IPV and relationship power (Aim 2). A rigorous process evaluation will explore mechanisms of change, contextual factors, and implementation considerations to inform future refinement and scale-up, using programmatic data, participant questionnaires, and qualitative interviews with participants and providers (Aim 3). The proposed study builds directly on our R34 intervention development work to develop the evidence base for this youth-designed, multi-level HIV prevention intervention. If effective, Tu'Washindi will be ideally positioned for sustainable integration into existing youth-focused programming to expand and support PrEP use in this priority population.