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.

抽象的 肯尼亚已将每日口服 PrEP 扩大到众多人群，其中包括患有大量疾病的年轻女性。 对于许多开始口服 PrEP 的年轻女性来说，大量研究表明，存在感染艾滋病毒的风险。 停药率很高，而且他们不太可能受益于长期的新型 PrEP 产品。 作用较长，包括达匹韦林洗脱阴道环和卡博特韦肌肉注射，提供 1- 2 个月的保护，减少对使用者的依赖，记住每天服用世界卫生组织的药片。 指南中，这些产品正在被纳入肯尼亚和其他国家的日常临床指南。 口服 PrEP，有效扩大规模的一个关键策略是整合到现有计划中，例如那些 生殖保健（例如计划生育、产前、流产后护理），我们一直在研究如何 通过实施科学研究方案，我们优化了 PrEP 与这些环境的整合。 一直与公共诊所工作人员合作，介绍 PrEP，培训提供者提供 PrEP，建立 PrEP 的诊所和国家供应链机制，以及支持提供者和计划来克服 尽管有记录表明人们对 PrEP 的兴趣很高，但 PrEP 启动的频率很高 – 13- 35% 的 15-30 岁符合资格的女性在我们的计划生育和流产后诊所合作伙伴中 – 我们有 继续看到大量的计划退出、不遵守，并且只有中等能力来跟踪是否 PrEP 是根据性行为的波动和潜在的 HIV 暴露而重新启动的。 年轻女性对 PrEP 产品的需求推动了 PrEP 的继续进行，这些产品可提供谨慎、便利、 和安全。 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效果。 选择，支持长期使用 PrEP，并最终通过多步骤扩大艾滋病毒预防覆盖范围。 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 方案的可用性是否比 3- 与仅提供每日口服 PrEP 的时期相比，为期 6 个月的时期拟议的研究旨在：1) 开发一条途径，将可注射的卡博特韦和达匹韦林环添加到通过以下方式提供的现有 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) 确定是否将可注射的卡博特韦和达匹韦林环整合到现有的 PrEP 计划中 通过 在 12 个设施中进行阶梯楔形整群随机试验，以及 3) 询问 PrEP 中的潜在弱点 选择干预包括：a) 提供者犹豫和客户体验，b) 基于选择的艾滋病毒质量 预防咨询。