PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women

项目摘要 - 意义：撒哈拉以南非洲地区的年轻女性（16-24 岁）是 艾滋病毒感染易感人群每周新增感染人数约 7,000 例。每日口服 定期采取暴露前预防 (PrEP) 是预防艾滋病毒的一种非常有效的方法。早期 在这一人群中全球推广 PrEP 的经验表明了人们对 PrEP 的热情，但也存在障碍 坚持和计划保留。建议的干预措施：PrEP My Way 是一种新型 PrEP 输送系统 包括基于临床的 PrEP 启动，然后是同行提供的 HIV 自检套件、PrEP 补充装、 用于淋病和衣原体自我取样、妊娠测试和避孕药补充的阴道拭子（如果） 想要的。基于社会认知理论，我们的总体假设是 PrEP My Way 将克服关键问题 目前，耻辱和结构性障碍限制了 PrEP 的使用，从而使年轻女性能够提高她们的能力 性健康。创新：据我们所知，这项研究是第一个开发同行交付的 PrEP 试剂盒的研究 使用、性传播感染 (STI) 检测和避孕。干预措施充分利用了 随时可用的技术（例如 SMS、WhatsApp、Vimeo）来支持套件和基于对等的使用 赋权。方法：我们将首先开发、定制和完善 PrEP My Way，供年轻女性使用 肯尼亚基苏木（目标 1）。我们将采用以客户为中心的迭代方法，涉及约 15 次个人访谈 以及两次焦点小组讨论（每人约 5 名女性），以优化设计 PrEP My Way 套件（包括 教学材料）和同伴交付系统（包括沟通和工具包交付计划）。我们会 然后测试干预措施的可行性、可接受性以及对 PrEP 依从性和计划的初步影响 保留（目标 2）。我们将随机抽取 100 名肯尼亚女性进行 PrEP My Way 与标准护理（即临床护理） 基础上提供 PrEP 和性健康服务）并跟踪 6 个月。将评估可行性 在 1、3 和 6 个月时收到试剂盒并能够按照方案使用其组件。可接受性将是 通过 6 个月时的混合方法访谈确定。初步影响将通过干燥来评估 血斑替诺福韦水平（依从性）和 6 个月时试剂盒使用/就诊（保留）作为主要指标 结果。将通过问卷调查探讨潜在的影响和调节社会行为因素 基线和 6 个月。研究者/环境：我们的团队拥有丰富的相关经验，以确保 该提案的成功，包括 PrEP 依从性和行为科学（PI：Haberer 博士） 马萨诸塞州总医院），性健康服务提供（肯尼亚医学研究中心的 Bukusi 博士） 研究所，华盛顿大学的 Baeten 博士），以及 PrEP 和 STI 的远程交付和监测 （埃默里大学的西格勒博士）以及产品设计（内罗毕的 ARK）。未来方向：PrEP 我的方式是 设计时考虑了有限的基础设施需求，从而为现实世界的大规模实施创造了潜力 可以在未来的 R01 拨款中进行测试。

PROJECT SUMMARY - Significance: Young women (16-24 years old) in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a highly effective means of HIV prevention when taken regularly. Early experience with the global rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence and program retention. Proposed intervention: PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, our overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health. Innovation: This study is the first, to our knowledge, to develop a peer-delivered kit for PrEP use, sexually transmitted infection (STI) testing, and contraception. The intervention leverages smart use of readily available technology (e.g., SMS, WhatsApp, Vimeo) to support use of the kit and peer-based empowerment. Approach: We will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). We will use a client-centered, iterative approach, involving ~15 individual interviews and two focus group discussions (with ~5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). We will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). We will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic- based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at baseline and 6 months. Investigators/environment: Our team has extensive relevant experience to ensure the success of this proposal, including PrEP adherence and behavioral science (PI: Dr. Haberer at Massachusetts General Hospital), sexual health service delivery (Dr. Bukusi at the Kenyan Medical Research Institute, Dr. Baeten at the University of Washington), and remote delivery and monitoring for PrEP and STIs (Dr. Siegler at Emory), as well as product design (ARK in Nairobi). Future directions: PrEP My Way is designed with limited infrastructure needs, thus creating potential for real world implementation at scale that can be tested in a future R01 grant.