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

通过基于药房的新型 PrEP 交付平台提高肯尼亚少女和年轻女性的 PrEP 效果

• 批准号: 10402054
• 负责人: Elizabeth Anne BUKUSI
• 金额: $ 61.54万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10402054
• 关键词: AIDS prevention; Address; Adherence; Africa; Client; Client satisfaction; Climate; Clinic; Clinical effectiveness; Collaborations; Contraceptive Usage; Contraceptive methods; Counseling; County; Data; Family Planning; Female Adolescents; Focus Groups; HIV; HIV Seronegativity; Hair; Health; Health care facility; Incidence; Individual; Injectable; Intervention; Kenya; Measures; Mental Depression; Modeling; Motion; Nurses; Oral; Outcome; Participant; Pathway interactions; Pharmacists; Pharmacy facility; Positioning Attribute; Prevalence; Prevention; Provider; Public Facilities; Qualitative Evaluations; Quality of Care; Randomized; Research Design; Research Infrastructure; Risk; Southern Africa; Standard Model; System; TMC120-R147681; Technology; Tenofovir; Time; Translations; Vaginal Ring; Wait Time; Woman; arm; base; cis-female; cofactor; cost; cost effective; cost effectiveness; cost estimate; cost outcomes; design; economic impact; effectiveness implementation study; effectiveness testing; health economics; implementation outcomes; improved; mathematical model; microcosting; novel; novel strategies; pill; pre-exposure prophylaxis; primary outcome; programs; prospective; reversible contraceptive; satisfaction; scale up; secondary outcome; social stigma; success; tool; young woman

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.

对于青春期女孩和年轻女性（AGYW），艾滋病毒事件仍然不可接受。预曝光 预防（PREP）HIV预防工具很有希望，基于Tenofovir（TFV）的每日口服准备 dapivirine阴道环（DPV-VR）由WHO推荐给艾滋病毒危险的妇女。肯尼亚是领导者 为了在非洲进行准备，并正在努力增加与AGYW作为优先组的准备访问权限。我们的 在肯尼亚的计划生育（FP）诊所中，团队开创了综合准备交付；然而，有40％的肯尼亚妇女 无需与设施接口（包括零售药店）接口的避孕避孕，并将错过 基于设施的准备平台。零售药店可以增加与PREP的高危个人的选择 正在努力定义肯尼亚药房销售Prep的途径。我们改编了FP诊所 - 由护士 - 纳维格员准备的基于基于的准备模型和试验的准备交付，以寻求避孕 药房。 AGYW提供了经常发起的每日口服准备，计划继续使用，并愿意付款 用于药房的准备。伯恩伯恩是口服准备下降的常见原因，可以通过 提供DPV-VR。通过与肯尼亚卫生部，国家和县级的密切合作， 我们在肯尼亚基苏木（Kisumu）的20个药房中提出了一个集群RCT，艾滋病毒患病率高达28％ 在妇女中 - 测试在零售药店使用护士 - 武器的有效性来增强AGYW 准备使用。我们将扩大我们成功的飞行员，以提供每日口头准备和DPV-VR以及前瞻性的 确定AGYW之间的准备预期（启动，持久性，依从性）。这种有效的实践 Hybrid RCT旨在通过评估临床有效性以及 实施和成本成果。我们假设将护士 - 武器与药房结合 PREP将提供一种具有成本效益的策略，用于在HIV高负荷中提供新颖的HIV预防工具 设置。 AIM 1将确定护士 - 武者对准备，持久性和依从性的影响 在通过2臂群集在基于药房的准备递送模型中寻求避孕的AGYW中 在肯尼亚基苏木的20个零售药店的HIV阴性AGYW中RCT。寻求避孕的AGYW将会 提供准备和自我选择的每日口服准备或DVR-VR。主要结果将是AGYW的比例 访问启动PREP的避孕，在10个月中使用，并粘附（由TFV或DPV量化） 头发水平）。次要结果将包括PrEP选择（PREP PILLS与DPV-VR），STI事件和 依从性辅助因子。 AIM 2将确定潜在的障碍和促进者可接受性，可行性和客户 对AGYW访问零售药店的AGYW访问PREVIGATORS和DPV-VR的满意度 Proctor等人指导的定性评估。 AIM 3将估计实施的成本效益 基于药房的预备送货与护士 - 纳维克人。这将是提高准备访问的第一个研究 用于使用基于药房的模型的AGYW，并将主要药房在管道中提供新颖的准备剂。