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

在肯尼亚基于药房的 PrEP 交付模式中评估青春期女孩和年轻女性的性传播感染情况。

• 批准号: 10878139
• 负责人: Elizabeth Anne BUKUSI
• 金额: $ 39.66万
• 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/10878139
• 关键词: Address; Administrative Supplement; Affect; Africa; Age; Antimicrobial Resistance; Behavior; Biological Assay; Characteristics; Chlamydia trachomatis; Clinic; Contraceptive Agents; Contraceptive methods; Cox Proportional Hazards Models; Data; Data Collection; Decision Making; Detection; Diagnosis; Enrollment; Evaluation; Family Planning; Female Adolescents; Focus Groups; Guidelines; HIV; HIV Infections; HIV risk; Health; Incidence; Infection; Infertility; Infrastructure; Kenya; Learning; Logistic Regressions; Measures; Modeling; Molecular; Morbidity - disease rate; Motivation; Neisseria gonorrhoeae; Outcome; Parents; Pattern; Perinatal; Pharmacy facility; Population; Positioning Attribute; Prevalence; Procedures; Proctor framework; Research; Research Infrastructure; Risk; STI prevention; Sex Behavior; Sexual Partners; Sexually Transmitted Diseases; Site; South Africa; Specimen; Syphilis; Syphilis Serodiagnosis; Testing; Time; Trichomonas vaginalis; Woman; Work; chronic pelvic pain; cisgender; condoms; demographics; experience; follow-up; implementation evaluation; infection burden; intimate partner violence; longitudinal analysis; pre-exposure prophylaxis; rapid test; risk perception; satisfaction; secondary outcome; syndemic; uptake; young woman

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.

抽象的 性传播感染 (STI) 对顺性别少女和年轻女性的影响尤为严重 (AGYW) 经常经历性传播感染并发症的人，包括不孕、慢性盆腔疼痛和增加患性病的风险 东非大约四分之一的 AGYW 感染艾滋病毒和围产期发病率。 沙眼衣原体 (CT)、淋病奈瑟菌 (NG)、阴道毛滴虫 (TV) 或梅毒 在肯尼亚，艾滋病毒和性传播感染。 AGYW 中包括一种综合征，40% 的新 HIV 感染发生在 AGYW 中，但研究尚未解决 肯尼亚卫生部正在开发以药房为基础的治疗方法。 HIV 暴露前预防 (PrEP) 模型，以扩大 AGYW 在药房寻求避孕的机会。 与 AGYW 相比，在提供 PrEP 时更频繁地接受 PrEP，并且有与 HIV 风险相关的行为 关于在设施外使用 FP 和/或 PrEP 的 AGYW 的性传播疾病负担的数据很少—— 填补这一证据空白可以为解决艾滋病毒和性传播感染的高收益战略提供信息。 在肯尼亚基苏木开展 AGYW 集群随机对照试验，以测试在药房寻求 AGYW 的 PrEP 交付模式 避孕 (R01HD108041)——截至 2023 年 6 月，PrEP 的采用率非常高，次要结果包括 CT/NG。 4 家药房的 AGYW 子集的患病率 迄今为止，所有提供 CT/NG 检测的 AGYW 均已接受，占 26%。 来自南非诊所女性的 CT 感染数据表明，性传播感染检测促进了 PrEP 的使用。 目前尚不清楚 STI 检测是否会影响药房环境中 PrEP 的使用，在此补充申请中，我们建议。 在基于药房的 PrEP 交付模式内对 AGYW 中的性传播感染进行全面评估（目标 1）， 纵向分析以了解 STI 检测和诊断如何影响 AGYW 中 PrEP 使用结果 （目标 2），以及定性实施评估，以了解 STI 测试在这种独特的情况下的用户体验 背景（目标 3），这将结合起来为 AGYW 的综合 PrEP/STI 测试交付提供证据 肯尼亚的药房。所有目标都在母研究的科学范围内，扩大正在进行的研究。 程序和数据收集，并利用现有的研究基础设施来补充我们正在进行的研究。 集群随机对照试验比较零售药房的 PrEP 交付模式并收集新的 STI 数据，包括 分子 NG 抗菌药物耐药性检测，我们在评估 AGYW 中的性传播感染方面具有独特的优势。 我们团队在药房 AGYW 中实施 HIV/STI 研究的专业知识将使我们能够执行 我们提议的一年内的工作将为 AGYW 中性传播感染的负担提供证据。 在药房获取避孕药具和/或 PrEP 我们将确定数据来指导药房的性传播感染检测。 AGYW（艾滋病毒/性传播感染预防的优先群体）的 PrEP 模型，并提供适用于更广泛的证据 人口。