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

项目总结/摘要 少女和年轻妇女（15-24岁）是艾滋病毒感染率最高的群体， 撒哈拉非洲。暴露前预防（PrEP）有可能大大减少新的艾滋病毒感染， 这个人口。然而，在非洲妇女中进行的几项PrEP试验中，依从性太低， 结果是有效性。关于PrEP依从性的驱动因素以及如何优化PrEP依从性的大量知识差距 因此，必须加以解决，以利用PrEP对年轻妇女的承诺。拟议的培训 在这个K23指导以病人为导向的研究职业发展奖申请研究计划将 允许凯瑟琳·科斯，医学博士获得必要的技能，以实现她的职业目标，成为一个国家卫生研究院- 在设计和测试艾滋病毒预防干预措施方面具有专业知识的临床研究人员， 强调对妇女的坚持干预。在这份K23提案中，在专家和 专门的指导团队，科斯博士将使用混合方法的方法来测试的中心假设， 以社区坚持俱乐部模式为基础，针对以下群体的健康需求和优先事项进行干预： 年轻女性将是可行的，可接受的，并最终增加年轻女性对PrEP的坚持， 东非。社区坚持俱乐部战略，患者参加由医疗保健领导的小组访问 提供药物和坚持支持的工作人员，正在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 PrEP递送。这项提案将利用正在进行的基于人口的研究的资源， 在肯尼亚和乌干达的32个农村社区招募了32万多人，以测试艾滋病毒治疗， 预防策略（PART，NCT 01864603，PI Havlir，K23主要指导者）。将提供口头 使用富马酸替诺福韦酯/恩曲他滨（TDF/FTC）对6，400名将接受随访的女性和男性进行PrEP 通过客观生物学措施（替诺福韦）进行季度研究访视以进行监测和依从性评估 毛发和血浆中的浓度）和自我报告。基于候选人先前对PrEP的研究， 本建议将针对以下具体目标：（1）阐明影响 在东非社区环境中接受PrEP的年轻妇女坚持PrEP;（2） 制定社区坚持俱乐部干预措施，以增加年轻女性对PrEP的坚持;（3） 评估坚持俱乐部干预的可行性、可接受性和初步效果， 拟议的研究是基于差异化服务提供的原则， 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 以及干预措施的开发、测试和评估。本提案的结果将导致R 01 应用程序测试社区坚持俱乐部干预的年轻女性在大规模的PrEP 该试验的最终目标是减轻全世界妇女的艾滋病毒负担。

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.