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.

青春期女孩和年轻女性（AGYW）的艾滋病毒感染率仍然高得令人无法接受。 预防 (PrEP) HIV 预防工具前景广阔，基于替诺福韦 (TFV) 的每日口服 PrEP 和 世界卫生组织推荐用于艾滋病毒高危顺性别女性的达匹韦林阴道环（DPV-VR）是领先的。 为非洲的 PrEP 提供提供服务，我们正在努力增加 PrEP 的获取，并将 AGYW 作为我们的优先群体。 团队在肯尼亚的计划生育 (FP) 诊所率先开展了综合 PrEP 实施，目前为止，40% 的肯尼亚妇女 无需与设施（包括零售药店）连接即可获得避孕药具，并且会被错过 基于设施的 PrEP 平台可以增加为高危人群提供 PrEP 的选择。 我们正在努力确定肯尼亚药房提供的 PrEP 途径。我们调整了 FP 诊所。 基于 PrEP 模型和由护士导航员协助的试点 PrEP 交付，用于寻求避孕的 AGYW AGYW 经常提供每日口服 PrEP，计划继续使用，并愿意付费。 药房的 PrEP 药物负担是减少口服 PrEP 的一个常见原因，可以通过以下方法解决： 通过与肯尼亚卫生部在国家和县级的密切合作，提供 DPV-VR。 我们提议在肯尼亚基苏木的 20 家药店开展集群随机对照试验（该地区的艾滋病毒感染率高达 28%） 在女性中——测试零售药房利用护士导航员来增强 AGYW 的有效性 我们将扩大我们成功试点的范围，提供每日口服 PrEP 和 DPV-VR，并前瞻性地提供。 确定 AGYW 的 PrEP 结果（启动、坚持、坚持）。 混合随机对照试验旨在通过评估临床有效性和 我们努力将护士导航员与基于药房的人员结合起来。 PrEP 将为艾滋病毒高负担地区的 AGYW 提供一种具有成本效益的战略，提供新型艾滋病毒预防工具 目标 1 将确定护士导航员对 PrEP 启动、持久性和依从性的影响。 AGYW 通过 2 臂集群在基于药房的 PrEP 交付模式中寻求避孕 将在肯尼亚基苏木 20 家寻求避孕的 AGYW 零售药店对 HIV 阴性 AGYW 进行随机对照试验。 提供 PrEP 和自行选择每日口服 PrEP 或 DVR-VR 主要结果将是 AGYW 的比例。 获得避孕措施，包括启动 PrEP、坚持使用 10 个月并坚持（通过 TFV 或 DPV 量化） 次要结局包括 PrEP 选择（PrEP 药丸与 DPV-VR）、STI 发病率和 目标 2 将确定可接受性、可行性和客户的潜在障碍和促进因素。 护士导航员的满意度以及 AGYW 通过 DPV-VR 交付在零售药房获取 PrEP 的满意度 Proctor 等人指导的定性评估将评估实施的成本效益。 由护士导航员进行基于药房的 PrEP 实施 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，并将推动药房提供新的 PrEP 制剂。