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

通过社区依从俱乐部干预，优化非洲年轻女性对 PrEP 的依从性

• 批准号: 10161842
• 负责人: Catherine Anne Stimets Koss
• 金额: $ 19.9万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10161842
• 关键词: AIDS prevention; Address; Adherence; Adopted; Africa; Africa South of the Sahara; African; Age; Biological; Caring; Clinic; Clinical; Clinical Investigator; Communities; Complement; Data; Development; Development Plans; Education; Effectiveness; Enrollment; Evaluation; Female Adolescents; Focus Groups; Fostering; Fumarates; Funding; Goals; HIV; HIV Infections; HIV risk; Hair; Health; Health Personnel; Health Priorities; Health Services; Healthcare; Home; Household; Human immunodeficiency virus test; Incidence; Individual; Intervention; Interview; Kenya; Knowledge; Lead; Literature; Measures; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methods; Modality; Modeling; Monitor; Oral; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pilot Projects; Plasma; Population; Population Study; Pregnancy; Prevention strategy; Provider; Reproductive Health; Research; Research Methodology; Resources; Risk; Rural; Sampling; Self Efficacy; Site; Structure; Sum; Surveys; Tenofovir; Testing; Time; Training; Uganda; United States National Institutes of Health; Viral; Visit; Woman; Youth; base; career; career development; cost; design; emtricitabine; follow-up; group intervention; implementation barriers; male; men; method development; novel; pre-exposure prophylaxis; prevent; preventive intervention; psychosocial; research and development; retention rate; risk perception; searchable database; service delivery; skills; therapy development; treatment strategy; young woman

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.

项目概要/摘要 青春期女孩和年轻女性（15-24 岁）是亚裔中艾滋病毒感染率最高的群体之一。 撒哈拉非洲。暴露前预防 (PrEP) 有可能显着减少艾滋病毒新发感染 这个人口。然而，在非洲女性中进行的几项 PrEP 试验中，依从性太低，无法 产生效果。关于 PrEP 依从性的驱动因素以及如何优化的知识存在巨大差距 因此，必须解决这一问题，以便实现 PrEP 对年轻女性的承诺。拟议的培训 K23 指导的以患者为导向的研究职业发展奖申请中的研究计划和研究计划将 让凯瑟琳·科斯 (Catherine Koss) 医学博士获得必要的技能，以实现她成为 NIH 的职业目标 资助临床研究人员，具有设计和测试艾滋病毒预防干预措施的专业知识， 强调对妇女的依从性干预。在本次K23提案中，在专家的指导下 Koss 博士将在专门的指导团队中使用混合方法来检验中心假设： 干预措施建立在社区依从俱乐部模式的基础上，并根据健康需求和优先事项进行定制 年轻女性将是可行的、可接受的，并最终提高年轻女性对 PrEP 的依从性 东非。社区依从俱乐部策略，其中患者参加由医疗保健人员领导的小组访问 提供药物和依从性支持的工作人员，已成功用于艾滋病毒治疗（包括 青年）以提高护理和病毒抑制的保留率，但尚未适应 PrEP 交付。该提案将利用正在进行的基于人群的研究的资源，该研究已 在肯尼亚和乌干达农村地区的 32 个社区招募了超过 320,000 人来测试艾滋病毒治疗和 预防策略（SEARCH，NCT01864603，PI Havlir，K23 初级导师）。 SEARCH 将提供口头 使用富马酸替诺福韦二吡呋酯/恩曲他滨 (TDF/FTC) 对 6,400 名女性和男性进行 PrEP，并进行随访 在季度研究访问中通过客观生物措施（替诺福韦）进行监测和依从性评估 头发和血浆中的浓度）和自我报告。以候选人之前对 PrEP 的研究为基础， 为了提高女性的依从性，本提案将解决以下具体目标：（1）阐明影响因素 东非社区环境中接受 PrEP 的年轻女性坚持 PrEP 的情况； (2) 至 制定社区依从性俱乐部干预措施，以提高年轻女性对 PrEP 的依从性； (3) 至 评估依从俱乐部干预的可行性、可接受性和初步有效性 接受 PrEP 的年轻女性。拟议的研究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。该提案的结果将导致 R01 应用程序大规模测试社区依从俱乐部对年轻女性 PrEP 的干预 试验的最终目标是减轻全世界妇女的艾滋病毒负担。

项目成果

Cost-effectiveness of easy-access, risk-informed oral pre-exposure prophylaxis in HIV epidemics in sub-Saharan Africa: a modelling study.

撒哈拉以南非洲艾滋病毒流行中易于获得、风险告知的口服暴露前预防的成本效益：一项模型研究。

• 发表时间: 2022-05
• 作者: Phillips, Andrew N;Bershteyn, Anna;Revill, Paul;Bansi;Kripke, Katharine;Boily, Marie;Martin;Johnson, Leigh F;Mukandavire, Zindoga;Jamieson, Lise;Meyer;Hallett, Timothy B;Ten Brink, Debra;Kel
• 通讯作者: Kel

The Association Between Social Network Characteristics and Tuberculosis Infection Among Adults in 9 Rural Ugandan Communities.

乌干达 9 个农村社区成年人的社交网络特征与结核病感染之间的关联。

• 发表时间: 2023-02-08
• 作者: Marquez, Carina;Chen, Yiqun;Atukunda, Mucunguzi;Chamie, Gabriel;Balzer, Laura B;Kironde, Joel;Ssemmondo, Emmanuel;Mwangwa, Florence;Kabami, Jane;Owaraganise, Asiphas;Kakande, Elijah;Abbott, Rachel;Ssekyanzi, Bob;Koss, Catherine;Kamya, Moses
• 通讯作者: Kamya, Moses

Distance to clinic is a barrier to PrEP uptake and visit attendance in a community in rural Uganda.

距离诊所较远是乌干达农村社区接受 PrEP 和就诊的一个障碍。

• 发表时间: 2019
• 影响因子: 6
• 作者: Mayer, Christopher M;Owaraganise, Asiphas;Kabami, Jane;Kwarisiima, Dalsone;Koss, Catherine A;Charlebois, Edwin D;Kamya, Moses R;Petersen, Maya L;Havlir, Diane V;Jewell, Britta L
• 通讯作者: Jewell, Britta L

Uptake of a patient-centred dynamic choice model for HIV prevention in rural Kenya and Uganda: SEARCH SAPPHIRE study.

肯尼亚和乌干达农村地区采用以患者为中心的动态选择模型来预防艾滋病毒：SEARCH SAPPHIRE 研究。

• 发表时间: 2023-07
• 影响因子: 6
• 作者: Kabami, Jane;Kakande, Elijah;Chamie, Gabriel;Balzer, Laura B;Petersen, Maya L;Camlin, Carol S;Nyabuti, Marilyn;Koss, Catherine A;Bukusi, Elizabeth A;Kamya, Moses R;Havlir, Diane V;Ayieko, James
• 通讯作者: Ayieko, James