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

项目摘要--意义：撒哈拉以南非洲的年轻妇女(16-24岁)是 艾滋病毒感染方面的弱势群体，每周约有7,000例新感染病例。每日口述 暴露前预防(PrEP)是定期服用的一种非常有效的艾滋病毒预防手段。早些时候 在这一人群中全球推广PrEP的经验表明，人们对PrEP充满热情，但也存在障碍 遵守和计划保留。建议干预：Prep My Way是一种新的PrEP传递系统 包括以诊所为基础的PrEP启动，然后是同行交付的艾滋病毒自我检测试剂盒，PrEP重新填充， 淋病和衣原体的阴道拭子自我采样、妊娠试验和避孕补充物，如果 想要。基于社会认知理论，我们的总体假设是PrEP My Way将克服关键 耻辱和结构性障碍目前限制了PrEP的使用，从而使年轻女性能够促进 性健康。创新：据我们所知，这项研究是第一次为PrEP开发同行交付的试剂盒 使用、性传播感染(STI)检测和避孕。这种干预措施巧妙地利用了 随时可用的技术(例如，短信、WhatsApp、Vimeo)，以支持该套件的使用和基于对等的 赋权。方法：我们将首先开发、定制和改进PrEP，以供年轻女性使用 肯尼亚基苏木(目标1)。我们将使用以客户为中心的迭代方法，包括约15次个人采访 和两次焦点小组讨论(每个讨论约5名女性)，以优化设计PrEP My Way工具包(与 教学材料)和同行交付系统(包括通信和套件交付计划)。我们会 然后测试干预措施的可行性、可接受性以及对PrEP遵守和计划的初步影响 保留(目标2)。我们将随机选择100名肯尼亚妇女进行PrEP My Way与标准护理(即，诊所- 以提供PrEP和性健康服务为基础)，并跟踪6个月。将评估可行性 在1个月、3个月和6个月收到试剂盒，并能够按照协议使用其组件。可接受性将是 在6个月时通过一次混合方法的面试确定。初步影响将由SDED进行评估 以6个月的血点替诺福韦水平(依从性)和试剂盒使用情况/临床就诊次数(保留)为主要指标 结果。潜在的影响和调解社会行为因素的调查问卷将在 基线和6个月。调查人员/环境：我们的团队拥有丰富的相关经验，以确保 这一提议的成功，包括遵守PrEP和行为科学(PI：Dr.Haberer at 马萨诸塞州总医院)，性健康服务提供(肯尼亚医学研究所的Bukusi医生 华盛顿大学Baeten博士)，以及对PrEP和性传播感染的远程交付和监测 (埃默里的西格勒博士)，以及产品设计(内罗毕的方舟)。未来方向：准备我的方式是 设计满足有限的基础设施需求，从而创造了在现实世界中大规模实施的潜力 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.