Targeted interventions to address the multi-level effects of gender-based violence on PrEP uptake and adherence among adolescent girls and young women in Kenya

项目总结/摘要 这个R34应用程序，由早期研究人员领导，旨在了解和解决多种方式， 基于性别的暴力（GBV）影响青春期女孩有效使用口服暴露前预防（PrEP）， 肯尼亚15-24岁的青年妇女。在撒哈拉以南非洲，青年女青年占所有艾滋病毒新感染者的25% 非洲尽管PrEP有可能降低这一人群的艾滋病毒风险，但年轻人的依从性很低 非洲妇女在以前的研究，限制其保护性的好处。目前的许多研究旨在增加PrEP吸收 但据我们所知，没有一个国家对性别暴力幸存者采取有针对性的PrEP干预措施。 在肯尼亚，年龄偏大的青年妇女一生中身体或性性别暴力的发生率超过40%， 艾滋病毒发病率较高，PrEP依从性较低。迫切需要采取有效干预措施，解决性别暴力问题， PrEP吸收和坚持的具体障碍，以减少这一弱势群体的艾滋病毒风险。我们建议进行 形成性研究，以更好地了解个人，合作伙伴，社区和诊所层面的障碍，以准备吸收和 AGYW GBV幸存者的依从性。在这项形成性工作的基础上，我们将制定和试行一项干预措施， 解决这些障碍。这项研究将嵌套在正在进行的梦想艾滋病毒预防活动的AGYW， 包括由锡亚亚县影响研究与发展组织（IRDO）实施的PrEP交付， 肯尼亚西部。具体目标是：1）描述年轻的性别暴力者接受和坚持PrEP的模式 幸存者，并了解他们独特的障碍和促进者使用PrEP，通过混合方法形成 研究; 2）制定和预测试干预措施，解决多层次的GBV相关障碍，以PrEP的使用，其中 AGYW;以及3）实施并评估由此产生的干预措施的可行性，安全性和初步效果 通过试点集群随机对照试验（cRCT）与100 AGYW GBV幸存者在四个PrEP交付站点。 关键的干预组成部分可以在所有AGYW的坚持支持活动中整合和维持， 包括性别暴力筛查;为成功使用PrEP树立榜样视频短片;坚持支持俱乐部; 安全规划和披露;以及供应商培训和支持。试点cRCT的主要结局将包括 可行性和安全性。我们还将确定干预是否显示出增加PrEP吸收的希望， 坚持和6个月的持久性。我们将进行参与者深入访谈和提供者焦点小组， 探索PrEP决策的可接受性和影响。拟议的工作是创新的，因为它建立在 现有的梦想倡议，并使青年参与干预设计。对基于性别的暴力幸存者的关注是新颖的， 我们在努力消除艾滋病毒流行方面存在重大差距。如果成功的话，这些发现将为一个国家提供可靠的初步数据。 R 01建议测试这种干预对PrEP吸收、持久性和依从性生物标志物的有效性， 一个全功率的多站点RCT

PROJECT SUMMARY/ABSTRACT This R34 application, led by an Early Stage Investigator, aims to understand and address the multiple ways in which gender-based violence (GBV) impacts the effective use of oral pre-exposure prophylaxis (PrEP) by adolescent girls and young women (AGYW) ages 15-24 in Kenya. AGYW account for 25% of all HIV new infections in sub-Saharan Africa. Although PrEP has the potential to reduce HIV risk in this population, adherence has been low among young African women in previous studies, limiting its protective benefit. Many current studies aim to increase PrEP uptake and adherence among AGYW, but none, to our knowledge, incorporate targeted PrEP interventions for GBV survivors. In Kenya, the lifetime prevalence of physical or sexual GBV among AGYW is over 40%, and GBV is associated with higher HIV incidence and lower adherence to PrEP. There is an urgent need for effective interventions to address GBV- specific barriers to PrEP uptake and adherence, to reduce HIV risk in this vulnerable group. We propose to conduct formative research to better understand individual-, partner-, community-, and clinic-level barriers to PrEP uptake and adherence in AGYW GBV survivors. Based on this formative work, we will develop and pilot an intervention to address these barriers. The research will be nested within the ongoing DREAMS HIV prevention activities for AGYW, including PrEP delivery, implemented by Impact Research and Development Organization (IRDO) in Siaya County, western Kenya. The specific aims are 1) to characterize patterns of PrEP uptake and adherence among young GBV survivors, and to understand their unique barriers and facilitators to PrEP use, by means of mixed-methods formative research; 2) to develop and pre-test an intervention that addresses multi-level GBV-related barriers to PrEP use among AGYW; and 3) to implement and assess the feasibility, safety, and preliminary effects of the resulting intervention through a pilot cluster randomized-controlled trial (cRCT) with 100 AGYW GBV survivors at four PrEP delivery sites. Key intervention components can be integrated and sustained within adherence support activities for all AGYW, and include GBV screening; video vignettes to role model successful PrEP use; adherence support clubs; counseling on safety planning and disclosure; and provider training and support. Primary outcomes of the pilot cRCT will include feasibility and safety. We will also determine whether the intervention shows promise in increasing PrEP uptake, adherence, and persistence at 6 months. We will conduct participant in-depth interviews and provider focus groups to explore acceptability and effects on PrEP decision-making. The proposed work is innovative because it builds on the existing DREAMS Initiative and engages youth in intervention design. The focus on GBV survivors is novel and fills a critical gap in our efforts to end the HIV epidemic. If successful, the findings will provide robust preliminary data for an R01 proposal to test the efficacy of this intervention on PrEP uptake, persistence, and biologic markers of adherence in a fully powered multisite RCT.