Effectiveness of PrEP product choice on HIV prevention coverage among young women in Kenya seeking reproductive health services

PrEP 产品选择对寻求生殖健康服务的肯尼亚年轻女性艾滋病毒预防覆盖率的有效性

• 批准号: 10761048
• 负责人: Renee A. Heffron
• 金额: $ 69.33万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-14 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10761048
• 关键词: AIDS prevention; Adherence; Advocate; Age; Atopobium vaginae; Behavioral Sciences; Blood; Caring; Client; Clinic; Clinical; Clinical Trials; Cluster randomized trial; Collaborations; Consolidated Framework for Implementation Research; Contraceptive Agents; Counseling; Country; Dapivirine; Dependence; Diphosphates; Drops; Educational Materials; Effectiveness; Eligibility Determination; Epidemic; Exposure to; Family Planning; Female Adolescents; Focus Groups; Frequencies; Guidelines; HIV; Healthcare; Human immunodeficiency virus test; Incidence; Individual; Injectable; Injections; Intervention; Interview; Intramuscular Injections; Kenya; Length; Measures; Methods; Oral; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Population; Prevention; Process; Protocols documentation; Provider; Qualitative Research; Randomized; Randomized, Controlled Trials; Recommendation; Reproductive Health; Reproductive Health Services; Research; Research Methodology; Residual state; Risk; Safety; Services; Sex Behavior; Sexual Health; Social support; Southern Africa; System; Tenofovir; Time; Training; Vaginal Ring; Woman; Work; antenatal; clinical epidemiology; community based research; community consultation; design; experience; implementation science; improved; interest; member; pill; pre-exposure prophylaxis; product development; programs; scale up; secondary outcome; supply chain; unintended pregnancy; uptake; young woman

ABSTRACT Daily oral PrEP has been scaled up in Kenya for numerous populations, including young women with substantial risk for HIV. For many young women who start oral PrEP, numerous studies have demonstrated that discontinuation rates are high and they unlikely benefit from long-term HIV protection. Newer PrEP products that are longer acting, including dapivirine-eluting vaginal rings and intramuscular injections of cabotegravir, offer 1- 2 months of protection and less dependence on the user to remember to take a daily pill. Following WHO guidelines, these products are being integrated into clinical guidelines in Kenya and other countries. For daily oral PrEP, a key strategy for efficient scale up was integration into existing programs, such as those for reproductive health care (e.g., family planning, antenatal, postabortal care) and we have been studying ways to optimize integration of PrEP into these settings. Through implementation science research protocols, we have been working with public clinic staff to introduct PrEP, train providers to delivery PrEP, develop linkages between clinics and national supply chain mechanisms for PrEP, and support providers and programs to overcome challenges. Despite documented high levels of interest in PrEP yielding high frequency of PrEP initiation – 13- 35% of eligible women ages 15-30 years in our family planning and post-abortal clinic partners – we have continued to see high levels of program drop out, non-adherence, and only moderate ability to track whether PrEP is re-started in alignment with fluctuating sexual behavior and potential exposure to HIV. These barriers to PrEP continuation are driven by young women’s needs for PrEP products that afford discretion, convenience, and safety. It is yet unknown whether the availability of multiple HIV PrEP products in a PrEP program will yield a degree of choice, support longer term use of PrEP, and ultimately, greater HIV prevention coverage. Through a multi-step process invoking formative work and a stepped-wedge cluster randomized trial, the research team proposes to determine whether the availability of a suite of PrEP options yields greater HIV protection coverage over a 3- and 6- month period relative to periods when only daily oral PrEP is available. The proposed study aims to: 1) develop a pathway to add injectable cabotegravir and dapivirine ring into existing PrEP services offered through in reproductive health clinics in Kenya leveraging qualitative and community-based research methods, 2) determine whether integration of injectable cabotegravir and dapivirine ring into existing PrEP programs improves PrEP uptake and persistence among young women accessing reproductive health services via a stepped-wedge cluster randomized trial in 12 facilities, and 3) interrogate potential weak points in the PrEP choice intervention including: a) provider hesitancy and client experiences, b) quality of choice-based HIV prevention counseling.

摘要 每日口服PrEP在肯尼亚已扩大到许多人群，包括患有大量 艾滋病毒的风险。对于许多开始口服PrEP的年轻女性来说，许多研究表明， 停药率很高，他们不太可能受益于长期的艾滋病毒保护。较新的PrEP产品， 包括dapivirine洗脱阴道环和cabotegravir肌内注射， 2个月的保护和更少的依赖用户记得每天服用药丸。以下谁 这些产品正在被纳入肯尼亚和其他国家的临床指南。日常 口服PrEP，有效扩大规模的一个关键策略是整合到现有的计划中，例如 生殖保健（例如，计划生育、产前和产后护理），我们一直在研究如何 优化PrEP与这些环境的整合。通过实施科学研究协议，我们 一直与公共诊所工作人员合作，介绍PrEP，培训提供者提供PrEP， 诊所和国家供应链机制的PrEP，并支持供应商和计划，以克服 挑战尽管记录了对PrEP的高度兴趣，但PrEP启动的频率很高- 13- 35%的15-30岁符合条件的妇女在我们的计划生育和堕胎后诊所合作伙伴-我们有 继续看到高水平的计划辍学，不遵守，只有中等能力，以跟踪是否 PrEP重新开始与波动的性行为和潜在的艾滋病毒暴露保持一致。这些障碍， PrEP的延续是由年轻女性对PrEP产品的需求驱动的，这些产品提供了自由裁量权，便利性， 和安全性 目前尚不清楚在PrEP计划中提供多种HIV PrEP产品是否会产生一定程度的预防效果。 选择，支持长期使用PrEP，最终扩大艾滋病毒预防覆盖面。通过多步骤 过程调用形成性工作和阶梯楔形集群随机试验，研究小组建议， 确定一套PrEP方案的可用性是否会在3- 10年内产生更大的艾滋病毒保护覆盖率， 和6个月的时间段相对于只有每日口服PrEP可用的时间段。拟议的研究旨在：1） 开发一种途径，将可注射的cabotegravir和dapivirine环添加到现有的PrEP服务中， 在肯尼亚的生殖健康诊所利用定性和基于社区的研究方法，2） 确定是否将注射用cabotegravir和dapivirine环整合到现有的PrEP计划中 通过以下方式提高获得生殖健康服务的年轻妇女对PrEP的接受率和持久性： 在12个设施中进行的阶梯楔形群随机试验，以及3）询问PrEP中的潜在弱点 选择性干预包括：a）提供者的犹豫和客户的经验，B）基于选择的艾滋病毒的质量 预防咨询。