RCT of an Implementation Science Tool to Integrate HIV testing into Family Planning Services

简介(申请人提供)：自1998年以来，麦克莱兰博士在人类免疫缺陷病毒和性传播疾病的预防和治疗方面一直是一名富有成效的研究人员。他发表了120篇原创研究的同行评议手稿，并在13项研究拨款中担任首席研究员，其中包括8项由NIH资助的主要研究。McClelland博士在肯尼亚领导华盛顿大学蒙巴萨艾滋病毒/性传播疾病研究现场，在那里他开发了一套出色的研究和培训基础设施。他过去和现在的学员包括18名硕士(15名担任主席)、10名博士(5名担任主席)和26名博士后研究人员(21名担任初级导师)。这些学员在职业发展、出版和获得额外资金以支持他们的培训和研究方面都取得了异常成功的成就。超过75%的麦克莱兰博士的受训者一直留在学术机构或其他机构，他们专注于以患者为中心的研究。McClelland博士获得了两个享有盛誉的导师奖：华盛顿大学公共卫生学院杰出导师奖(2012)和医学部年度导师奖(2015)。职业生涯规划、制度环境和制度承诺本申请中提出的研究和指导侧重于多学科实施科学。在过去的几年里，麦克莱兰博士一直在扩大他在这个新兴而重要的领域的研究计划。20世纪90年代末，作为一名年轻的艾滋病毒研究人员，麦克莱兰博士开始了他的职业生涯，他在非洲进行了艾滋病毒和性病预防和治疗的临床和流行病学研究。当时的关键研究问题主要与“什么是有效的”有关。今天，有了一系列经过验证的预防和治疗工具，将重点放在“如何”实施这些干预措施以最大限度地扩大人口影响的研究是一个自然的延伸。McClelland博士正处于他职业生涯的理想阶段，他将扩大他对多学科指导团队的领导，同时通过结构化课程、独立学习和探索新的指导策略来获得新技能并改进他的方法。麦克莱兰博士指导的首要目标是支持受训者在完全研究独立的道路上取得进展。华盛顿大学是这项研究和指导计划的理想环境，每年有10亿美元的研究资金，大量赠款支持年轻研究人员进行以患者为导向的研究，以及传染病、流行病学、全球健康和实施科学方面的一流项目，每年吸引大量优秀的学员。华盛顿大学对麦克莱兰博士及其研究和指导计划有着坚定的承诺。研究计划将艾滋病毒和计划生育服务结合起来，是一种在改善向妇女提供艾滋病毒治疗和预防服务方面大有希望的办法。美国政府2010年的全球健康倡议战略强调将这些服务联系起来，以提高效率、降低成本并改善资源匮乏环境中妇女的健康状况。艾滋病毒检测是护理和预防的门户。将艾滋病毒检测整合到计划生育诊所可以为更多的女性打开这一重要的大门。对文献的回顾支持整合这些服务的可行性，但强调了进一步研究的必要性。在这项K24应用中，我们提出了一种系统分析和改进方法(SAIA)的试验，以优化在肯尼亚蒙巴萨县计划生育诊所就诊的妇女的艾滋病毒检测率。这项工作将与蒙巴萨县卫生局(DOH)和肯尼亚国家艾滋病和性传播感染控制方案(NASCOP)合作进行，以确保迅速传播成果并促进成功战略的扩大。我们的建议包括三个具体目标。我们将首先进行一项整群随机试验，比较SAIA方法和常规程序对12个干预诊所和12个对照FP诊所首次就诊者HIV检测率的影响。其次，为了确定SAIA培训是否会产生持久的效果，我们将在多一年后比较SAIA干预机构和对照机构首次就诊的FP诊所的HIV检测率，在此期间，干预部门的FP诊所将被鼓励继续使用SAIA工具，而无需研究小组的进一步支持或培训。第三，我们将估计应用SAIA干预措施与标准程序相比的增量成本。预算影响将从支付方(DOH)的角度进行估计。我们设想，每个目标都将由麦克莱兰博士的一名导师领导。与Sherr博士(实施科学)和Barnabas博士(成本计算/预算影响分析)的合作和团队指导将提供对本研究和指导提案成功至关重要的多学科专业知识。在蒙巴萨县整合艾滋病毒和计划生育服务将提高艾滋病毒检测率，为妇女与其他艾滋病毒预防和治疗服务的联系打开大门。对SAIA干预措施的严格测试将为在艾滋病毒负担高的广泛环境中扩大规模提供一个框架。

DESCRIPTION (provided by applicant): Dr. McClelland has been a highly productive researcher in human immunodeficiency virus (HIV) and sexually transmitted disease (STD) prevention and treatment since 1998. He has published 120 peer-reviewed manuscripts of original research and been Principal Investigator on 13 research grants including 8 major NIH- funded studies. Dr. McClelland leads the University of Washington (UW) Mombasa HIV/STD Research Field Site in Kenya, where he has developed an outstanding research and training infrastructure. His past and present trainees include 18 masters (15 as chair), 10 PhD (5 as chair), and 26 post-doctoral researchers (21 as primary mentor). These trainees have been exceptionally successful in career advancement, publishing, and securing additional funding to support their training and research. More than 75% of Dr. McClelland's mentees have remained in academics or other settings where they focus on patient-oriented research. Dr. McClelland has received two prestigious mentoring awards; the UW School of Public Health Outstanding Mentor Award (2012), and the Department of Medicine Mentor of the Year Award (2015). Career Plan, Institutional Environment, and Institutional Commitment The research and mentoring proposed in this application focus on multidisciplinary implementation science. During the past several years, Dr. McClelland has been expanding his research program in this emerging and important field. As a young HIV researcher in the late 1990s, Dr. McClelland began his career by conducting clinical and epidemiological studies of HIV and STD prevention and treatment in Africa. At that time, the key research questions related primarily to `what' works. Today, with a range of proven prevention and treatment tools available, it is a natural extension to include research that focuses on `how' to implement these interventions to maximize population impact. Dr. McClelland is at an ideal point in his career to expand his leadership of multidisciplinary mentoring teams while gaining new skills and refining his approach through structured courses, independent study, and exploration of new mentoring strategies. The overarching objective of Dr. McClelland's mentorship is to support trainees' progress on the path to full research independence. The UW is an ideal environment for this research and mentoring program, with >1 billion dollars in annual research funding, numerous grants to support young investigators in patient-oriented research, and top-ranked programs in Infectious Diseases, Epidemiology, Global Health, and Implementation Science attracting a large number of superb trainees each year. The UW has a strong commitment to Dr. McClelland and his research and mentoring plan. Research Plan Integration of HIV and family planning (FP) services is an approach that holds considerable promise for improving delivery of HIV treatment and prevention services to women. The United States Government Global Health Initiative Strategy of 2010 emphasized linkage of these services to increase efficiency, lower costs, and improve the health of women in low-resource settings. Testing for HIV is the gateway to care and prevention. Integrating HIV testing into FP clinics could open this essential gateway to far more women. Reviews of the literature support the feasibility of integrating these services, but highlight the need for additional research. In this K24 application, we propose a trial of a systems analysis and improvement approach (SAIA) to optimize rates of HIV testing in women presenting to FP clinics in Mombasa County, Kenya. This work will be conducted in collaboration with the Mombasa County Department of Health (DOH) and Kenya's National AIDS and STI Control Programme (NASCOP), ensuring rapid dissemination of results and facilitating scale up of successful strategies. Our proposal includes three specific aims. We will first conduct a cluster-randomized trial comparing the effect of the SAIA approach versus usual procedures on rates of HIV testing in first-time attendees at 12 intervention versus 12 control FP clinics. Second, to determine whether the SAIA training results in a lasting effect, we will compare HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control facilities after an additional year, during which FP clinics in the intervention arm will be encouraged to continue to use the SAIA tools without further support or training from the study team. Third, we will estimate the incremental cost of applying the SAIA intervention versus standard procedures. Budget impact will be estimated from the payer (DOH) perspective. We envision that each aim will be led by one of Dr. McClelland's mentees. Collaboration and team mentoring with Drs. Sherr (Implementation Science) and Barnabas (Costing/Budget Impact Analysis) will provide the multidisciplinary expertise that is key to the success of this research and mentoring proposal. Integrating HIV and FP services in Mombasa County will result in improved rates of HIV testing, opening the gateway for linkage of women to other HIV prevention and treatment services. Rigorous testing of the SAIA intervention will provide a framework for scale-up in a wide range of settings with a high burden of HIV.