Optimizing Adherence to PrEP among Young African Women through a Community Adherence Club Intervention

项目摘要/摘要 青春期女孩和年轻妇女(15-24岁)在以下地区艾滋病毒发病率最高： 撒哈拉非洲。暴露前预防(PrEP)有可能显著减少新的艾滋病毒感染 这群人。然而，在非洲妇女中进行的几项PrEP试验中，依从性太低，无法 结果是有效的。在遵守PrEP的驱动因素以及如何优化方面存在大量知识差距 因此，必须解决这一问题，以便利用初级保健方案对年轻妇女的承诺。拟议中的培训 而研究计划在本次K23指导下以患者为导向的研究事业发展奖的申请中将 允许医学博士凯瑟琳·科斯获得必要的技能，以实现成为NIH的职业目标- 资助临床调查员，具有设计和测试艾滋病毒预防干预措施的专业知识，并拥有 强调对妇女的依从性干预。在这份K23提案中，在一位专家和 专注的指导团队，Koss博士将使用混合方法来测试中心假设 干预以社区遵守俱乐部模式为基础，并根据健康需求和优先事项量身定做 年轻女性将是可行的、可接受的，并最终增加年轻女性对PrEP的依从性 东非。社区坚持俱乐部战略，患者参加由医疗保健人员领导的团体访问 用于药物供应和依从性支持的工作人员，正成功地用于艾滋病毒治疗(包括 在青年中)，以提高护理和病毒抑制的保留率，但尚未适应 准备送货。这项提案将利用一项正在进行的基于人口的研究的资源，该研究已经 在肯尼亚和乌干达农村的32个社区招募了超过32万人，以测试艾滋病毒治疗和 预防策略(Search，NCT01864603，Pi Havlir，K23初级导师)。搜索会提供口述 替诺福韦富马酸异丙酯/恩曲他滨(TDF/FTC)给6400名男女进行跟踪治疗 在通过客观生物措施(替诺福韦)监测和依从性评估的季度研究访问中 头发和血浆中的浓度)和自我报告。基于候选人先前对PrEP和 关于妇女的坚持，这项建议将涉及以下具体目标：(1)阐明影响妇女的因素 在东非以社区为基础的环境中接受预防接种的年轻妇女对预防接种计划的坚持情况； 建立社区遵守俱乐部干预措施，以提高年轻女性对PrEP的依从性； 评估遵守俱乐部干预的可行性、可接受性和初步有效性 服用PrEP的年轻女性。拟议的研究基于差异化服务交付的原则，并 与Koss博士的职业发展计划保持一致，以获得定性和混合方法研究方面的专业知识 以及干预开发、测试和评估。这项提案的结果将导致R01 在年轻女性中大规模测试社区依从性俱乐部干预的申请 试验的最终目标是减轻全世界妇女感染艾滋病毒的负担。

PROJECT SUMMARY/ABSTRACT Adolescent girls and young women (ages 15-24 years) have among the highest HIV incidence rates in sub- Saharan Africa. Pre-exposure prophylaxis (PrEP) has the potential to dramatically reduce new HIV infections in this population. However, in several PrEP trials conducted among women in Africa, adherence was too low to result in effectiveness. Substantial knowledge gaps on the drivers of, and how to optimize, adherence to PrEP must therefore be addressed in order to harness the promise of PrEP for young women. The proposed training and research plan in this K23 Mentored Patient-Oriented Research Career Development Award application will allow Catherine Koss, MD to acquire the necessary skills to achieve her career goal of becoming an NIH- funded clinical investigator with expertise in designing and testing HIV prevention interventions, with an emphasis on adherence interventions for women. In this K23 proposal, under the guidance of an expert and dedicated mentoring team, Dr. Koss will use a mixed methods approach to test the central hypothesis that an intervention building on the community adherence club model and tailored to the health needs and priorities of young women will be feasible, acceptable, and ultimately increase adherence to PrEP among young women in East Africa. The community adherence club strategy, in which patients attend group visits led by a health care worker for medication provision and adherence support, is being successfully used in HIV treatment (including among youth) to increase rates of retention in care and viral suppression, but has not yet been adapted for PrEP delivery. This proposal will leverage the resources of an ongoing population-based study that has enrolled over 320,000 individuals in 32 communities in rural Kenya and Uganda to test HIV treatment and prevention strategies (SEARCH, NCT01864603, PI Havlir, K23 primary mentor). SEARCH will provide oral PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) to 6,400 women and men who will be followed at quarterly study visits for monitoring and adherence assessment via objective biological measures (tenofovir concentrations in hair and plasma) and self-report. Building on the candidate's prior research on PrEP and adherence in women, this proposal will address the following specific aims: (1) to elucidate factors influencing adherence to PrEP among young women receiving PrEP in community-based settings in East Africa; (2) to develop a community adherence club intervention to increase adherence to PrEP among young women; (3) to evaluate the feasibility, acceptability, and preliminary effectiveness of the adherence club intervention among young women on PrEP. The proposed research is based on principles of differentiated service delivery and is aligned with Dr. Koss' career development plan to gain expertise in qualitative and mixed methods research and intervention development, testing, and evaluation. The findings of this proposal will lead to an R01 application to test a community adherence club intervention among young women on PrEP in a large-scale trial, with the ultimate goal of reducing the burden of HIV among women worldwide.