Enhancing PrEP outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform

少女和年轻妇女的艾滋病毒感染率仍然高得令人无法接受（青年妇女协会）。暴露前 预防（PrEP）艾滋病毒预防工具是有希望的，基于替诺福韦（TFV）的每日口服PrEP和 达匹韦林阴道环（DPV-VR）是世卫组织推荐用于有艾滋病毒感染风险的顺性别妇女的。肯尼亚是一个领导者 在非洲提供PrEP服务，目前正在努力增加PrEP服务，AGYW是一个优先群体。我们 团队率先在肯尼亚计划生育（FP）诊所提供综合PrEP服务;然而，40%的肯尼亚妇女 在没有与设施接触的情况下获得避孕药具，包括在零售药店， 基于设施的PrEP平台。零售药店可以增加PrEP接触高危人群的选择 目前正在努力确定肯尼亚药房提供PrEP的途径。我们改造了我们的FP诊所- 基于PrEP模型和试点PrEP交付由护士导航员为寻求避孕的AGYW提供便利， 药店AGYW提供每日口服PrEP频繁启动，计划继续使用，并愿意支付 在药店做预防措施药丸负担是减少口服PrEP的常见原因，可以通过以下方式解决 提供DPV-VR。通过与肯尼亚卫生部在国家和县级的密切合作， 我们建议在肯尼亚基苏穆的20家药店开展一项随机对照试验，该地区的艾滋病流行率高达28 在妇女中-测试在零售药店利用护士导航员提高AGYW的有效性 PrEP使用。我们将扩大我们成功的试点，提供每日口服PrEP和DPV-VR， 确定AGYW之间的PrEP结果（启动，持续性，依从性）。这种有效性-实施 混合RCT旨在通过评估临床有效性以及 实施和成本结果。我们假设，结合护士导航与药房为基础的 PrEP将提供一种具有成本效益的策略，为艾滋病毒高负担地区的AGYW提供新型艾滋病毒预防工具 设置.目标1将确定护士导航员对PrEP启动，持续和坚持的影响 在通过双臂集群在基于药店的PrEP提供模式中寻求避孕的AGYW中 在肯尼亚基苏穆的20家零售药店对艾滋病毒阴性的青少年妇女进行随机对照试验。AGYW寻求避孕将 提供PrEP和自我选择每日口服PrEP或DVR-VR。主要结局将是AGYW的比例 获得启动PrEP的避孕措施，持续使用10个月，和粘附（通过TFV或DPV定量 毛发水平）。次要结局将包括PrEP选择（PrEP药丸与DPV-VR）、STI发生率和 粘附辅助因子目标2将确定潜在的障碍和促进因素，以实现可接受性、可行性和客户 护士导航员的满意度和AGYW通过零售药店访问PrEP的DPV-VR交付 由普罗克特等人指导的定性评价。目标3将估计实施的成本效益 基于药房的PrEP输送与护士导航。这将是第一项旨在改善PrEP获取的研究 AGYW使用基于药房的模式，并将主要药房提供新的PrEP制剂。

HIV incidence remains unacceptably high for adolescent girls and young women (AGYW). Pre-exposure prophylaxis (PrEP) HIV prevention tools are promising, with tenofovir (TFV)-based daily oral PrEP and the dapivirine vaginal ring (DPV-VR) recommended by WHO for cisgender women at-risk for HIV. Kenya is a leader for PrEP delivery in Africa and efforts are ongoing to increase PrEP access with AGYW as a priority group. Our team pioneered integrated PrEP delivery in family planning (FP) clinics in Kenya; yet, 40% of Kenyan women access contraception without interfacing with facilities, including at retail pharmacies, and would be missed by facility-based PrEP platforms. Retail pharmacies can increase options for reaching at-risk individuals with PrEP and efforts are underway to define pathways for pharmacy-delivered PrEP in Kenya. We adapted our FP clinic- based PrEP model and piloted PrEP delivery facilitated by nurse-navigators for AGYW seeking contraception at pharmacies. AGYW offered daily oral PrEP frequently initiated, planned to continue use, and were willing to pay for PrEP at pharmacies. Pill burden was a common reason for declining oral PrEP and could be addressed by offering DPV-VR. Through close collaboration with the Kenya Ministry of Health both, national- and county-level, we propose a cluster RCT at 20 pharmacies in Kisumu, Kenya–a region with an HIV prevalence of up to 28% among women–to test the effectiveness of utilizing nurse-navigators at retail pharmacies to enhance AGYW PrEP use. We will expand on our successful pilot to offer both daily oral PrEP and the DPV-VR and prospectively ascertain PrEP outcomes (initiation, persistence, adherence) among AGYW. This effectiveness-implementation hybrid RCT is designed to expedite translation into practice by evaluating clinical effectiveness alongside implementation and cost outcomes. We hypothesize that combining nurse-navigators with pharmacy-based PrEP will provide a cost-effective strategy for delivering novel HIV prevention tools to AGYW in HIV high-burden settings. Aim 1 will determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model through a 2-arm cluster RCT among HIV-negative AGYW at 20 retail pharmacies in Kisumu, Kenya. AGYW seeking contraception will be offered PrEP and self-select daily oral PrEP or the DVR-VR. Primary outcomes will be proportion of AGYW accessing contraception that initiate PrEP, persist with use at 10 mos., and adhere (quantified by TFV or DPV hair levels). Secondary outcomes will include PrEP selection (PrEP pills vs. DPV-VR), STI incidence, and adherence cofactors. Aim 2 will identify potential barriers and facilitators to acceptability, feasibility, and client satisfaction of nurse-navigators and DPV-VR delivery for AGYW accessing PrEP at retail pharmacies through a qualitative evaluation guided by Proctor et al. Aim 3 will estimate the cost-effectiveness of implementing pharmacy-based PrEP delivery with nurse-navigators. This will be the first study aiming to improve PrEP access for AGYW using a pharmacy-based model and will prime pharmacies to deliver novel PrEP agents in the pipeline.