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

项目摘要/摘要 此R34应用程序由早期调查人员领导，旨在通过多种方式了解和解决以下问题 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措施(PrEP) 肯尼亚15-24岁的年轻妇女。AGYW占撒哈拉以南地区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中的艾滋病毒风险，但年轻人的依从性一直很低 在以前的研究中，非洲妇女，限制了它的保护益处。目前的许多研究旨在增加PrEP的摄取 并在AGYW中坚持，但据我们所知，没有一个纳入针对GBV幸存者的有针对性的PrEP干预措施。 在肯尼亚，AGYW中身体或性GBV的终生流行率超过40%，GBV与 较高的HIV发病率和较低的PrEP依从性。迫切需要有效的干预措施来解决GBV-- 对PrEP的吸收和依从性的具体障碍，以降低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、社区和临床层面的PrEP吸收和 AGYW GBV幸存者的依从性。在这项形成性工作的基础上，我们将制定和试点一项干预措施 解决这些障碍。这项研究将嵌套在AGYW正在进行的DREAMS艾滋病毒预防活动中， 包括由影响研究和发展组织(IRDO)在Siaya县实施的PrEP交付， 肯尼亚西部。具体目标是1)描述幼年GBV摄取和黏附PrEP的模式 幸存者，并了解他们通过混合形成性方法使用PrEP的独特障碍和促进者 研究；2)开发和预先测试干预措施，解决PrEP使用中与GBV相关的多层次障碍 3)实施和评估由此产生的干预措施的可行性、安全性和初步效果 通过试点整群随机对照试验(CRCT)，在四个PrEP交付地点对100名AGYW GBV幸存者进行了试验。 关键干预组成部分可以整合到所有AGYW的遵守支持活动中并保持下去，以及 包括GBV筛查；成功使用PrEP榜样的视频片段；遵守支持俱乐部；咨询 安全规划和披露；以及供应商培训和支持。CRCT试点的主要成果将包括 可行性和安全性。我们还将确定干预措施是否显示出增加PrEP摄入量的前景， 坚持，坚持6个月。我们将对参与者进行深入访谈和供应商焦点小组，以 探索可接受性和对PrEP决策的影响。拟议的工作具有创新性，因为它建立在 现有的梦想倡议，并让青年参与干预设计。对GBV幸存者的关注是新颖的，填补了 我们在努力结束艾滋病毒流行方面存在重大差距。如果成功，这些发现将为 R01建议测试这种干预对PrEP摄取、持久性和依从性的生物标记物的有效性 全功率多站点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.