PDF(Pubmed)
Abstract：
BACKGROUND: In Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators.
METHODS: The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored.
CONCLUSIONS: We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025.
BACKGROUND: ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.
METHODS: The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored.
CONCLUSIONS: We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025.
BACKGROUND: ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.
摘要：
背景：在肯尼亚，65%的性活跃未婚女性使用现代避孕药具，与其他人群相比，艾滋病毒感染风险增加的人群。锚定艾滋病毒预防服务，包括暴露前预防（PrEP），值得信赖的避孕药具提供了有效接触这一重要人群的机会。在肯尼亚,几乎一半(40%)的妇女在传统医疗保健设施之外获得避孕服务，比如零售药店。因此，将PrEP服务整合到零售药店可能会增加接触少女和年轻女性(AGYW)的选择，她们可以从PrEP中受益。肯尼亚正在努力为药房提供的PrEP服务定义护理途径，包括不支持和支持的模型与护士导航。
方法：AGYWPharmacyPrEP研究是一项在基苏木进行的非盲2臂整群随机对照试验，肯尼亚。目的是确定不受支持的与受支持的药房提供的PrEP服务对PrEP启动的影响，持久性,以及AGYW寻求避孕的依从性。提供药房提供商主导的PrEP交付的20家零售药房将以1：1的比例随机分配，以接收或不接收护士导航员来支持PrEP交付。合格AGYW(n=1900，总计，n=950/臂)将≥15岁，在药房购买避孕方法。训练有素的药房提供者将为符合条件的AGYW提供每日口服PrEP或每月DPV阴道环。主要试验结果是开始PrEP（在1个月时使用PrEP），持久性（在10个月时使用PrEP），和依从性（通过头发样品中TFV或DPV的水平定量）。此外,几个次要(性传播感染发生率，PrEP方法选择,PrEP依从性的预测因素)和探索性结果(HIV发病率，护理质量,避孕方法组合)将被探索。
结论：我们假设药房提供的PrEP服务由护士导航器支持，而不是单独由药房提供者提供，将改善AGYW寻求避孕的PrEP结果。我们的结果将有助于政策制定者更好地了解如何为PrEP和主要药房实施这种新颖的差异化服务模式，以便在管道中交付新的PrEP代理商（例如，长效注射剂和多用途技术)。该研究于2023年5月13日启动，预计将于2025年2月完成。
背景：ClinicalTrials.gov（NCT05467306），于2022年7月20日注册。
方法：AGYWPharmacyPrEP研究是一项在基苏木进行的非盲2臂整群随机对照试验，肯尼亚。目的是确定不受支持的与受支持的药房提供的PrEP服务对PrEP启动的影响，持久性,以及AGYW寻求避孕的依从性。提供药房提供商主导的PrEP交付的20家零售药房将以1：1的比例随机分配，以接收或不接收护士导航员来支持PrEP交付。合格AGYW(n=1900，总计，n=950/臂)将≥15岁，在药房购买避孕方法。训练有素的药房提供者将为符合条件的AGYW提供每日口服PrEP或每月DPV阴道环。主要试验结果是开始PrEP（在1个月时使用PrEP），持久性（在10个月时使用PrEP），和依从性（通过头发样品中TFV或DPV的水平定量）。此外,几个次要(性传播感染发生率，PrEP方法选择,PrEP依从性的预测因素)和探索性结果(HIV发病率，护理质量,避孕方法组合)将被探索。
结论：我们假设药房提供的PrEP服务由护士导航器支持，而不是单独由药房提供者提供，将改善AGYW寻求避孕的PrEP结果。我们的结果将有助于政策制定者更好地了解如何为PrEP和主要药房实施这种新颖的差异化服务模式，以便在管道中交付新的PrEP代理商（例如，长效注射剂和多用途技术)。该研究于2023年5月13日启动，预计将于2025年2月完成。
背景：ClinicalTrials.gov（NCT05467306），于2022年7月20日注册。
