Evaluating sexually transmitted infections among adolescent girls and young women within a pharmacy-based PrEP delivery model in Kenya.

摘要 性传播感染对顺性青春期女孩和年轻妇女的影响不成比例 (AGYW)经常出现性传播感染并发症，包括不孕不育、慢性盆腔疼痛和增加患病风险 HIV感染与围产期发病率。在东非，大约四分之一的AGYW人患有衣原体 沙眼衣原体(CT)、淋球菌(NG)、阴道毛滴虫(TV)或梅毒。在肯尼亚，艾滋病毒和性传播疾病 在AGYW中，有40%的新艾滋病毒感染发生在AGYW中，但尚未进行研究 在这一人群中，性传播疾病落后于艾滋病毒。肯尼亚卫生部正在开发基于药房的递送服务 艾滋病毒暴露前预防模式(PrEP)，以扩大获取机会。AGYW在药房寻求避孕 与AGYW相比，在提供PrEP时更频繁地接受PrEP，并有与艾滋病毒风险相关的行为 在设施中。关于AGYW在设施外访问FP和/或PrEP的STI负担的数据很少- 填补这一证据空白可以为应对艾滋病毒和性传播感染的高产出战略提供信息。我们的团队目前领导着一支 在肯尼亚基苏木的AGYW之间建立RCT集群，以测试在药店为AGYW寻求的PrEP递送模式 避孕(R01HD108041)--截至2023年6月，PrEP的吸收率非常高。次要结果包括CT/NG 在4家药店的AGYW的一个子集中的流行率。到目前为止，所有AGYW提供的CT/NG测试都被接受，26% 感染了CT。来自南非诊所妇女的数据表明，性传播感染检测刺激了PrEP的使用，但 目前尚不清楚STI检测是否会影响PrEP在药房环境中的使用。在这份补充申请中，我们建议 在以药房为基础的PrEP交付模式下对AGYW中的性传播感染进行综合评价(目标1)，a 纵向分析以了解STI检测和诊断如何影响AGYW中PrEP的使用结果 (目标2)，以及定性实施评估，以了解STI测试的用户体验 背景(目标3)，它们将结合在一起，为AGYW的综合PrEP/STI测试提供证据 肯尼亚的药店。所有目标都在母体研究的科学范围内，扩展正在进行的研究 程序和数据收集，并利用现有的研究基础设施。通过补充我们正在进行的 分组RCT比较零售药店的PrEP交付模式并收集新的STI数据，包括 在分子NG耐药性检测方面，我们在评估AGYW中的性传播感染方面具有独特的地位。 我们团队在药房的AGYW中实施艾滋病毒/STI研究的专业知识将使我们能够执行 建议在一年内完成工作。我们建议的研究将为青年性传播疾病的负担提供证据。 在药房获得避孕和/或PrEP。我们将确定数据以指导药房的STI检测 为预防艾滋病毒/性传播感染的优先小组AGYW准备模型，并提供适用于更广泛的 人口。

ABSTRACT Sexually transmitted infections (STIs) disproportionately affect cisgender adolescent girls and young women (AGYW) who often experience STI complications, including infertility, chronic pelvic pain, and increased risk for HIV acquisition and peripartum morbidity. Approximately one in four AGYW in East Africa have Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), or syphilis. In Kenya, HIV and STIs among AGYW comprise a syndemic with 40% of new HIV infections occurring in AGYW, yet research to address STIs lags behind HIV in this population. The Kenya Ministry of Health is developing pharmacy-based delivery models for HIV pre-exposure prophylaxis (PrEP) to expand access. AGYW seeking contraception at pharmacies more frequently accept PrEP when offered and have behaviors associated with HIV risk compared with AGYW at facilities. Few data exist on the burden of STIs among AGYW accessing FP and/or PrEP outside of facilities— filling this evidence gap could inform high-yield strategies to address HIV and STIs. Our team currently leads a cluster RCT among AGYW in Kisumu, Kenya to test models of PrEP delivery at pharmacies for AGYW seeking contraception (R01HD108041)—as of June 2023, PrEP uptake is very high. Secondary outcomes include CT/NG prevalence in a subset of AGYW at 4 pharmacies. To date, all AGYW offered CT/NG testing accepted, and 26% had CT infections. Data from women at clinics in South Africa suggest that STI testing motivates PrEP use, yet it is unknown if STI testing influences PrEP use in pharmacy settings. In this supplement application, we propose a comprehensive evaluation of STIs among AGYW within a pharmacy-based PrEP delivery model (Aim 1), a longitudinal analysis to understand how STI testing and diagnoses influence PrEP use outcomes among AGYW (Aim 2), and a qualitative implementation evaluation to understand user experiences of STI testing in this unique context (Aim 3), which will combine to provide evidence for integrated PrEP/STI testing delivery for AGYW within pharmacies in Kenya. All aims are within the scientific scope of the parent study, expand ongoing study procedures and data collection, and leverage existing research infrastructure. By supplementing our ongoing cluster RCT comparing PrEP delivery models in retail pharmacies and collecting new STI data, including on molecular NG antimicrobial resistance detection, we are uniquely positioned to evaluate STIs among AGYW. Our team’s expertise in implementing HIV/STI studies among AGYW in pharmacies will enable us to execute the proposed work in one year. Our proposed study will provide evidence on the burden of STIs among AGYW accessing contraception and/or PrEP at pharmacies. We will ascertain data to guide STI testing in pharmacy PrEP models for AGYW, a priority group for HIV/STI prevention, and provide evidence applicable to broader populations.