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发病率仍然高得令人无法接受(AGYW)。预曝光 预防(PrEP)艾滋病毒预防工具很有前途，基于替诺福韦(TFV)的每日口服PrEP和 达匹韦林阴道环(DPV-VR)是世卫组织推荐给艾滋病毒高危顺性女性使用的。肯尼亚是领头羊 关于在非洲交付PrEP，目前正在努力增加PrEP的机会，将AGYW作为优先群体。我们的 团队率先在肯尼亚的计划生育(FP)诊所提供综合PrEP；然而，40%的肯尼亚妇女 在不与包括零售药店在内的设施对接的情况下获得避孕措施，并将被 基于设施的PrEP平台。零售药店可以增加接触PrEP高危人群的选择 目前正在努力确定肯尼亚药房提供的PrEP的路径。我们调整了我们的FP诊所- 基于PrEP模型和护士导航员帮助AGYW寻求避孕的试点PrEP分娩 药店。AGYW每天提供经常发起的口服PrEP，计划继续使用，并愿意付费 为药店的PrEP做准备。药片负担是口服PrEP下降的一个常见原因，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两级的密切合作， 我们建议在肯尼亚基苏木的20家药店进行分组随机对照试验，该地区的艾滋病毒流行率高达28% 在女性中-测试在零售药店使用护士导航员来提高AGYW的有效性 准备使用。我们将扩大我们成功的试点，提供每日口头PrEP和DPV-VR，并具有前瞻性 确定AGYW之间的PrEP结果(启动、坚持、坚持)。这种有效性--实施 混合随机对照试验旨在通过评估临床有效性来加速转化为实践 实施和成本结果。我们假设把护士导航员和药房结合起来 PREP将为在艾滋病毒高负担地区向AGYW提供新的艾滋病毒预防工具提供具有成本效益的战略 设置。目标1将确定护士导航员对PrEP的启动、坚持和依从性的影响 在AGYW中，通过双臂集群在基于药房的PrEP交付模式中寻求避孕 在肯尼亚基苏木的20家零售药店的艾滋病毒阴性AGYW中进行随机对照试验。AGYW寻求避孕意愿 提供PrEP和自行选择的每日口服PrEP或DVR-VR。主要结果将是AGYW的比例 获得避孕措施，启动PrEP，在10个月内坚持使用，并坚持(以TFV或DPV量化 头发水平)。次要结果将包括PrEP选择(PrEP药丸与DPV-VR)、STI发生率以及 依从性辅因。目标2将确定可接受性、可行性和客户的潜在障碍和促进者 护士导航员和DPV-VR分娩方式对AGYW零售药店使用PrEP的满意度 由Proctor等人指导的定性评价。目标3将评估实施的成本效益 以药房为基础的PrEP分娩与护士导航员。这将是旨在改善PrEP获取的第一项研究 对于AGYW，将使用以药房为基础的模式，并将启动药房，以提供正在筹备中的新型PrEP药物。

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.