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

项目摘要 这个R 01应用程序，由一个早期阶段的研究者领导，旨在测试一个多层次社区的有效性- 基于干预措施，以增加青少年对口服暴露前预防（PrEP）的接受和依从性 肯尼亚的女童和青年妇女组织。在这种情况下，AGYW生活在两性不平等加剧的环境中 和亲密伴侣暴力（IPV）的风险，代表了一个特别容易感染艾滋病毒的大亚群 感染除了艾滋病毒感染率较高外，经历IPV的妇女不太可能开始和持续感染 与PrEP，限制了这种有效的生物医学预防干预的保护效益。PrEP的障碍 吸收和坚持发生在社会生态模型的多个层面，包括低个人自我效能， 伴侣的反对和社区的耻辱。Tu'Washindi na PrEP（我们是PrEP的赢家）是一个多层次， 专门为解决锡亚亚县青年女青年协会面临的这些挑战而设计的社区干预措施， 肯尼亚.由我们的团队设计，采用参与式方法，让当地AGYW（R34 MH 114519）参与， 包括三个组成部分，在6个月内交付：一个八届会议，授权为基础的支持俱乐部AGYW， 针对男性伴侣的社区宣传，以及针对夫妇的PrEP教育活动。活动的设计 将其纳入以青年为重点的方案拟订工作，以确保效率和可持续性。一个试点集群的结果- 在6个地点进行的100 AGYW的随机对照试验表明具有较高的可行性和可接受性， 初步有效性：干预组参与者的PrEP摄取和依从性高2倍（p<0.05）， 与对照组参与者相比，IPV发生频率更低或更严重。拟议的研究建立在这些有希望的结果之上， 目的是在22个行政病房进行的一项完全有效的随机分组对照试验中评估干预措施 在肯尼亚的锡亚亚县，每个病房招募72名AGYW（总N= 1，584）。主要目标（Aim 1）是测试 干预措施对PrEP摄取和分娩后立即依从性的有效性（分娩后6个月） 入组）和6个月后（第12个月）。作为次要目标，我们将测试对IPV的干预效果， 权力（目标2）。一个严格的过程评估将探索变化的机制，背景因素， 执行方面的考虑因素，以便利用方案数据、参与者 问卷调查，以及对参与者和提供者的定性访谈（目标3）。该研究直接建立在 我们的R34干预开发工作，为这个年轻人设计的多层次艾滋病毒开发证据基础， 预防干预。如果有效，Tu'Washindi将成为可持续融入现有 以青年为重点的方案，以扩大和支持在这一优先人群中使用PrEP。

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.