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: 9342984
• 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/9342984
• 关键词: AIDS population; 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; 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; arm; base; career; cost; disorder control; disorder prevention; 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; trial comparing; AIDS population; 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; 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; arm; base; career; cost; disorder control; disorder prevention; 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; 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.

描述（由适用提供）：McClelland博士自1998年以来一直是人类免疫缺陷病毒（HIV）和性传播疾病（STD）的疾病（STD）的高产研究人员。他已发表了120名对原始研究的同行评审手册，并在包括8项研究Grants Grants Grants Grants Grants Grants Grants研究者中发表了120个同行评审的手稿。麦克莱兰德博士领导肯尼亚的华盛顿大学蒙巴萨HIV/STD研究现场，在那里他开发了出色的研究和培训基础设施。他的过去和现在的学员包括18名大师赛（15名主席），10位博士学位（5名椅子）和26名博士后研究人员（21名主要导师）。这些学员在职业发展，出版和获得额外资金方面取得了非凡的成功，以支持他们的培训和研究。麦克莱兰博士的导师中有75％以上一直留在学者或其他关注患者研究的环境中。麦克莱兰德博士获得了两个著名的指导奖。大学公共卫生学院杰出导师奖（2012年）和医学部年度最佳导师奖（2015年）。职业计划，机构环境和机构承诺本申请中提出的研究和指导着重于多学科实施科学。在过去的几年中，麦克莱兰德博士一直在这个新兴和重要领域扩展他的研究计划。作为1990年代后期的年轻艾滋病毒研究员，麦克莱兰德博士在非洲对艾滋病毒和性病预防和治疗的临床和流行病学研究开始了他的职业生涯。当时，关键研究问题与“什么”有效。如今，有了一系列可靠的预防和治疗工具，是一种自然的扩展，其中包括专注于“如何”实施这些干预措施以最大程度地影响人群影响的研究。麦克莱兰德博士在职业生涯的理想点上扩大了他对多学科指导团队的领导地位，同时获得新的技能并通过结构化课程，独立研究和探索新的指导策略来完善他的方法。麦克莱兰德博士资师身份的总体目标是支持受训者在完全研究独立性的道路上的进步。 UW是该研究和心理计划的理想环境，年度研究资金> 10亿美元，许多赠款以支持年轻的研究人员从事以患者为导向的研究，以及在传染病，流行病学，全球健康和实施科学领域的顶级计划，每年吸引大量超级学员。西澳大学对麦克莱兰德博士及其研究和心理计划有坚定的承诺。艾滋病毒和计划生育（FP）服务的研究计划整合是一种方法，它具有提高艾滋病毒治疗和预防服务的良好承诺。 2010年的美国政府全球卫生倡议战略强调了这些服务的联系，以提高效率，降低成本并改善低资源环境中妇女的健康状况。艾滋病毒的测试是护理和预防的门户。将艾滋病毒测试纳入FP诊所可能会为更多女性打开这一重要门户。文献的评论支持整合这些服务的可行性，但强调了进行其他研究的必要性。在此K24应用程序中，我们提出了一项系统分析和改进方法（SAIA）的试验，以优化肯尼亚蒙巴萨县FP诊所的妇女中的艾滋病毒测试率。这项工作将与蒙巴萨县卫生部（DOH）和肯尼亚国家艾滋病和STI控制计划（NASCOP）合作进行，以确保快速传播结果并支持成功策略的规模。我们的建议包括三个具体目标。我们将首先进行集群的试验，以比较SAIA方法与通常在12个干预措施的初次参加者中的艾滋病毒测试率与12个对照FP诊所的艾滋病毒测试率。其次，为了确定SAIA培训是否会产生持久的影响，我们将比较SAIA干预中首次FP诊所参与者的HIV测试率与额外的一年后的控制设施进行比较，在此期间，将鼓励干预部门的FP诊所继续使用SAIA工具，而无需进行研究团队的进一步支持或培训。第三，我们将估计应用SAIA干预与标准程序的增量成本。预算影响将从付款人（DOH）的角度估算。我们设想，每个目标都将由麦克莱兰博士的孟德斯博士领导。与博士的合作和团队修补。 Sherr（实施科学）和Barnabas（成本上/预算影响分析）将提供多学科的专业知识，这是这项研究和修订建议成功的关键。在蒙巴萨县整合艾滋病毒和FP服务将提高艾滋病毒测试率，为妇女与其他艾滋病毒预防和治疗服务的联系开放。对SAIA干预的严格测试将提供一个框架，以在艾滋病毒高燃烧的各种环境中进行扩展。