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

项目概要-意义：撒哈拉以南非洲的年轻妇女（16-24岁）是 在艾滋病毒感染方面，弱势群体每周约有7 000例新感染。口服日 暴露前预防（PrEP）是一种非常有效的预防艾滋病毒的手段，如果定期服用。早期 在这一人群中全球推广PrEP的经验表明了对PrEP的热情，但也存在障碍， 坚持和方案保留。建议的干预措施：PrEP My Way是一种新型PrEP输送系统 包括基于诊所的PrEP启动，随后是用于HIV自我检测的同行交付试剂盒，PrEP补充， 阴道拭子淋病和衣原体自我采样，妊娠试验和避孕补充，如果 需要的话根据社会认知理论，我们的总体假设是，PrEP My Way将克服关键的 耻辱和结构性障碍，目前限制了PrEP的使用，从而使年轻妇女能够促进其 性健康创新：据我们所知，这项研究是第一个为PrEP开发同行交付试剂盒的研究。 使用、性传播感染（STI）检测和避孕。干预措施利用了 容易获得的技术（例如，短信，WhatsApp，Vimeo），以支持使用该工具包和基于同行 赋能方法：我们将首先开发，定制和完善PrEP My Way，用于年轻女性， 肯尼亚基苏穆（目标1）。我们将使用以客户为中心的迭代方法，包括~15个单独访谈 和两个焦点小组讨论（每个小组约有5名女性），以优化设计PrEP My Way套件（ 教学材料）和同行交付系统（包括通信和工具包交付计划）。我们将 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）。我们将随机选择100名肯尼亚妇女接受PrEP My Way与标准护理（即，诊所- 基于PrEP和性健康服务的交付），并跟踪他们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分。可接受性将是 通过6个月时的混合方法访谈确定。初步影响将由干燥的 血斑替诺福韦水平（依从性）和6个月时药盒使用/门诊就诊（保留）作为主要指标 结果。将通过调查问卷探索潜在的影响和调解社会行为因素， 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， 这项提案的成功，包括PrEP坚持和行为科学（PI：Haberer博士在 马萨诸塞州总医院），提供性健康服务（肯尼亚医学研究所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 (Dr.埃默里大学的西格勒），以及产品设计（内罗毕的方舟）。未来的方向：PrEP我的方式是 设计的基础设施需求有限，从而为真实的世界大规模实施创造了潜力， 可以在未来的R 01赠款中进行测试。

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.