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; 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（性传播感染）不成比例地影响cisgender青少年女孩和年轻女性 （AGYW）经常经历性传播感染并发症，包括不育，慢性骨盆疼痛和增加的风险 艾滋病毒获取和周围的垂死性。东非大约四分之一的AGYW患有衣原体 沙眼（CT），Neisseria Gonorrhoeae（NG），Trichomonas Vaginalis（TV）或梅毒。在肯尼亚，艾滋病毒和性传播疾病 在AGYW中，AGYW中有40％的新艾滋病毒感染汇编的集团，但研究以解决 在该人群中，性传播感染落后于艾滋病毒。肯尼亚卫生部正在开发基于药房的交付 HIV暴露前预防（PREP）的模型以扩大访问权限。 AGYW在药房寻求避孕 与AGYW相比 在设施。在AGYW访问FP和/或设施外的PREP中，几乎没有关于性传播感染的数据的数据 - 填补这一证据差距可以为解决艾滋病毒和性传播感染的高产策略提供信息。我们的团队目前领导 肯尼亚Kisumu的AGYW中的群集RCT，以测试药房的PREP交付模型，以寻求AGYW 避孕（R01HD108041） - 与2023年6月一样，预备摄取非常高。次要结果包括CT/NG 在4个药房的AGYW子集中患病率。迄今为止，所有AGYW都接受了CT/NG测试，而26％ 患有CT感染。南非诊所妇女的数据表明，性传播性传播感染测试激发了准备的使用 STI测试是否会影响药房设置中的PREP使用是否尚不清楚。在此补充申请中，我们建议 基于药房的准备递送模型（AIM 1）中AGYW之间的性传播感染的全面评估（AIM 1），A 纵向分析以了解STI测试和诊断如何影响AGYW中的PREP使用结果 （AIM 2）和定性实施评估，以了解此独特的STI测试的用户体验 上下文（AIM 3），将结合起来为agyw的集成准备/STI测试交付提供证据 肯尼亚的药房。所有目标都在父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架构。通过补充我们正在进行的 群集RCT比较零售药店中的准备交付模型并收集新的STI数据，包括ON 分子NG抗菌耐药性检测，我们在AGYW之间评估了性传播感染。 我们的团队在药房中实施AGYW之间实施HIV/STI研究的专业知识将使我们能够执行 拟议的工作一年。我们提出的研究将提供有关AGYW中传播感染烧伤的证据 在药房访问避孕和/或准备。我们将确定数据以指导药房中的性传播感染测试 AGYW的准备模型，AGYW是艾滋病毒/STI预防的优先组，并提供适用于更广泛的证据 人群。