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 肯尼亚的每日口服准备已缩放为众多人群，包括大量的年轻女性 艾滋病毒的风险。对于许多开始口头准备的年轻女性，许多研究表明 停药率很高，它们不太可能受益于长期的艾滋病毒保护。较新的准备产品 较长的表演，包括洗脱dapivirine的阴道环和cabo​​tegravir的肌肉注射，提供1- 2个月的保护和对用户的依赖较少，以记住服用每日药。跟随谁 指南，这些产品已纳入肯尼亚和其他国家 /地区的临床指南。每天 口头准备，有效规模的关键策略是集成到现有程序中，例如 生殖卫生保健（例如，计划生育，天线，毕业后护理），我们一直在研究方法 优化将PREP集成到这些设置中。通过实施科学研究协议，我们有 正在与公共诊所工作人员合作，介绍预备，火车提供者以提供准备，并建立联系 准备诊所和国家供应链机制，以及支持提供者和计划以克服的计划 挑战。尽管有记录了对准备的高度兴趣，从而产生高频率的准备计划 - 13-- 在我们的计划生育和产后诊所合作伙伴中，有35％的合格妇女在15-30岁的合格妇女中 - 我们有 继续看到高水平的程序退出，不遵守，并且只能跟踪是否适度 准备与性行为波动和潜在暴露于艾滋病毒的情况下重新启动。这些障碍 准备延续是由年轻女性对获得酌处权，便利性和的预备产品需求的驱动 和安全。 尚不清楚准备计划中多种艾滋病毒准备产品的可用性是否会产生一定程度 选择，支持长期使用PREP，并最终，更大的HIV预防覆盖范围。通过多步 过程调用形成性工作和阶梯式北方集群随机试验，研究团队提出的建议 确定一套准备选项的可用性是否在3-上产生更大的艾滋病毒保护覆盖范围 相对于仅每日口服准备的期间，相对于6个月的期限。拟议的研究旨在：1） 开发一条途径，将可注射的cabotegravir和Dapivirine戒指添加到通过的现有准备服务中 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） 确定是否将注射的Cabotegravir和Dapivirine环集成到现有的PREP程序中 改善通过A 在12个设施中阶梯式北向群集随机试验，3）在准备中询问潜在的弱点 选择干预措施包括：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。