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

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) 预防和治疗方面高产的研究人员。他发表了 120 篇经过同行评审的原创研究手稿，并被McClelland 博士是 13 项研究经费的首席研究员，其中包括 8 项由 NIH 资助的主要研究，领导华盛顿大学 (UW) 肯尼亚蒙巴萨 HIV/STD 研究现场。他建立了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 名担任主要导师）。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取得成功 超过 75% 的麦克莱兰博士的学员仍然留在学术界或其他专注于以患者为导向的研究领域。麦克莱兰获得了两项著名的指导奖：威斯康星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）。在过去的几年里，作为一名年轻的艾滋病毒研究人员，麦克莱兰博士一直在这一新兴的重要领域扩展他的研究项目。 20 世纪 90 年代，麦克莱兰博士开始了他的职业生涯，当时他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，当时的关键研究问题主要涉及“什么”有效，以及一系列经过验证的预防和治疗方法。麦克莱兰博士在他的职业生涯中处于一个理想的阶段，可以在获得新技能的同时扩大他对多学科指导团队的领导力。麦克莱兰博士指导的总体目标是支持学员在完全独立研究的道路上取得进展，华盛顿大学是这项研究和研究的理想环境。指导计划，每年提供超过 10 亿美元的研究经费，为支持年轻研究人员进行以患者为导向的研究提供大量资助，传染病、流行病学、全球健康和实施科学领域的顶级项目吸引了大批威斯康星大学对麦克莱兰博士及其研究和指导计划做出了坚定的承诺，艾滋病毒和计划生育 (FP) 服务的整合是一种为改善艾滋病毒治疗和服务的提供带来巨大希望的方法。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地区妇女的健康状况。整合艾滋病毒检测FP 诊所可以为更多女性打开这一重要途径。文献综述支持整合这些服务的可行性，但强调需要进行额外的研究。在此 K24 应用中，我们提出了一项系统分析和改进方法的试验。 SAIA）旨在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 (DOH) 和肯尼亚国家艾滋病和性传播感染控制计划合作开展。 (NASCOP)，我们的建议包括三个具体目标，首先确保比较 SAIA 方法与常规程序对 HIV 检测率的影响。 - 12 个干预和 12 个对照 FP 诊所的参加者 其次，为了确定 SAIA 培训是否产生持久效果，我们将在一年后比较 SAIA 干预和对照设施中首次 FP 诊所参加者的 HIV 检测率。其间将鼓励干预组中的 FP 诊所继续使用 SAIA 工具，而无需研究团队的进一步支持或培训。第三，我们将根据标准程序的影响来估计应用 SAIA 干预的增量成本。我们设想每个目标都将由 McClelland 博士的一位学员领导，并与 Sherr 博士（实施科学）和 Barnabas（成本/预算影响）进行合作和团队指导。分析）将提供对本研究成功至关重要的多学科专业知识，并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各种环境中扩大规模提供框架。