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

将艾滋病毒检测纳入计划生育服务的实施科学工具的随机对照试验

• 批准号: 9761315
• 负责人: Raymond Scott McClelland
• 金额: $ 17.7万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9761315
• 关键词: AIDS prevention; Achievement; Acquired Immunodeficiency Syndrome; Address; Africa; African; Age; Applications Grants; Area; Award; Birth Rate; Budgets; Career Mobility; Caring; Cessation of life; Client; Clinic; Clinical Research; Cluster randomized trial; Collaborations; Comprehensive Health Care; Cost Analysis; Counseling; Country; County; Data; Development; Doctor of Philosophy; Effectiveness; Engineering; Ensure; Environment; Facility Controls; Failure; Family Planning; Funding; Future; Grant; HIV; HIV Seropositivity; HIV diagnosis; Health; Health Sciences; Health Services Research; Human immunodeficiency virus test; Industrialization; Infectious Disease Epidemiology; Information Dissemination; International; Intervention; Kenya; Leadership; Manuscripts; Maternal Mortality; Medicine; Mentors; Mentorship; Methods; Midcareer Investigator Award in Patient-Oriented Research; Mother-to-child HIV transmission; Outcome; Peer Review; Performance; Policy Maker; Population; Postdoctoral Fellow; Pregnancy; Preparation; Prevention; Principal Investigator; Procedures; Public Health; Public Health Schools; Publishing; Reproducibility; Reproductive Health Services; Research; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Review Literature; STI prevention; Secure; Services; Sexually Transmitted Diseases; Site; State Government; Structure; System; Systems Analysis; Techniques; Testing; Time; Training; Training and Infrastructure; USAID; United States; United States National Institutes of Health; Universities; Ursidae Family; Washington; Woman; Women' s Health; Work; Writing; antenatal; base; care systems; career; cost; disorder control; epidemiology study; experience; global health; implementation research; implementation science; improved; multidisciplinary; patient oriented research; population health; prevention service; programs; public health relevance; reproductive; research study; scale up; skills; social stigma; standard of care; success; tool; treatment arm; treatment services; trial comparing

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.

DESCRIPTION（由申请人提供）：自1998年以来，McClelland博士一直是人类免疫缺陷病毒（HIV）和性传播疾病（STD）预防和治疗方面的高产研究员。他发表了120篇同行评议的原创研究手稿，并担任13项研究资助的首席研究员，其中包括8项主要的NIH资助研究。McClelland博士领导着华盛顿大学（UW）肯尼亚蒙巴萨艾滋病/性病研究基地，在那里他建立了一个杰出的研究和培训基础设施。先后培养硕士生18人（主讲15人），博士10人（主讲5人），博士后26人（主要导师21人）。这些受训者在职业发展、出版和获得额外资金支持他们的培训和研究方面都取得了非凡的成功。麦克利兰博士的学员中，有75%以上的人留在学术界或其他专注于以患者为导向的研究领域。McClelland博士曾两次获得著名的导师奖；西澳大学公共卫生学院杰出导师奖（2012年）和医学系年度导师奖（2015年）。职业规划、机构环境和机构承诺本申请中提出的研究和指导侧重于多学科实施科学。在过去的几年中，McClelland博士一直在扩大他在这一新兴和重要领域的研究计划。作为一名年轻的艾滋病研究人员，McClelland博士在20世纪90年代末开始了他的职业生涯，在非洲进行艾滋病毒和性病预防和治疗的临床和流行病学研究。当时，关键的研究问题主要与“什么”有效有关。如今，有了一系列经过验证的预防和治疗工具，自然就需要将重点放在“如何”实施这些干预措施以最大限度地影响人口方面的研究纳入其中。McClelland博士在他的职业生涯中处于一个理想的时刻，他可以扩大他在多学科指导团队中的领导能力，同时通过结构化课程、独立学习和探索新的指导策略获得新的技能和改进他的方法。McClelland博士指导的首要目标是支持学员在完全独立研究的道路上取得进展。华盛顿大学为这项研究和指导计划提供了理想的环境，每年有100亿美元的研究经费，大量的资助支持年轻的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顶级项目，每年吸引大量优秀的学员。西澳大学对麦克利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很有希望改善向妇女提供艾滋病毒治疗和预防服务的方法。美国政府2010年全球卫生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。艾滋病毒检测是获得护理和预防的途径。将艾滋病毒检测纳入计划生育诊所可以为更多的妇女打开这扇重要的大门。文献综述支持整合这些服务的可行性，但强调需要进一步的研究。在这个K24应用程序中，我们提出了一个系统分析和改进方法（SAIA）的试验，以优化肯尼亚蒙巴萨县计划生育诊所妇女的艾滋病毒检测率。这项工作将与蒙巴萨县卫生部和肯尼亚全国艾滋病和性传播感染控制规划合作开展，确保迅速传播成果，促进成功战略的推广。我们的建议包括三个具体目标。我们将首先进行一项集群随机试验，比较在12个干预诊所和12个对照计划生育诊所中，SAIA方法与常规程序对首次参加的HIV检测率的影响。其次，为了确定SAIA培训是否产生持久的效果，我们将在一年之后比较首次参加SAIA干预的计划生育诊所与对照设施的HIV检测率，在此期间，干预部门的计划生育诊所将被鼓励继续使用SAIA工具，而不需要研究小组的进一步支持或培训。第三，我们将估算应用SAIA干预与标准程序的增量成本。预算影响将从付款人（DOH）的角度进行估计。我们设想每个目标都将由麦克利兰博士的一名学员领导。与博士进行协作和团队指导。Sherr（实施科学）和Barnabas（成本/预算影响分析）将提供多学科专业知识，这是该研究和指导提案成功的关键。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高负担的广泛环境中扩大提供一个框架。