Implementation Science Approaches for Novel TB Diagnostics in HIV Prevalent Areas

在艾滋病毒流行地区实施新型结核病诊断的科学方法

• 批准号: 8415935
• 负责人: MAUNANK SHAH
• 金额: $ 13.62万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8415935
• 关键词: Address; Advocate; Africa South of the Sahara; Algorithms; Area; Award; Biological Assay; Cause of Death; Characteristics; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Communicable Diseases; Communities; Data; Decision Analysis; Detection; Development; Development Plans; Diagnosis; Diagnostic; Diagnostic tests; Diagnostics Research; Disease; Emerging Technologies; Environment; Enzyme-Linked Immunosorbent Assay; Epidemic; Evaluation; Faculty; Funding; Future; Goals; HIV; Health; Health system; Healthcare Systems; Heterogeneity; Incidence; Institution; International; Intervention; Knowledge; Laboratory Personnel; Lateral; Mentored Clinical Scientist Development Award (K08); Mentorship; Methodology; Modality; Modeling; Morbidity - disease rate; Multidrug-Resistant Tuberculosis; Nucleic Acid Amplification Tests; Outcome; Patient-Focused Outcomes; Patients; Performance; Persons; Population; Prevalence; Public Health; Public Health Schools; Recommendation; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Symptoms; Testing; Therapeutic; Time; Training; Treatment Cost; Tuberculosis; Uganda; United States National Institutes of Health; Universities; Urine; career development; case finding; clinical practice; cohort; comparative; comparative effectiveness; cost; cost effective; cost effectiveness; economic evaluation; evidence base; experience; implementation science; improved; infectious disease model; innovation; lipoarabinomannan; mortality; novel; novel diagnostics; novel strategies; post intervention; primary outcome; prospective; rapid detection; screening; secondary outcome; square foot; tool

DESCRIPTION (provided by applicant): My long-term goal is to become an independent investigator focusing on novel, cost- effective strategies for the detection and control of HIV and tuberculosis (TB). During the award period, I will build expertise in the methodology and conduct of clinical investigation, infectious disease modeling and economic evaluation. My career development plan combines formal didactics with relevant research experiences that address global HIV/TB priorities. A cross-disciplinary team of recognized leaders in HIV /TB research will provide professional and scientific mentorship during this phase of career development. Research: Effective control of TB and MDR-TB in HIV patients is hindered by low case-detection rates. Intensified Case Finding (ICF) of TB is advocated by the WHO as a strategy for HIV/TB control, but critical knowledge gaps exist. First, it is unknown if ICF of TB in HIV patients will increase case-detection and reduce HIV/TB mortality. Second, the optimal usage of emerging, rapid TB diagnostic tools as part of future ICF algorithms is not clear. Finally, the cost-effectiveness of novel ICF interventions has yet to be elucidated. The Aims of this proposal are: 1) To determine the impact of standardized TB ICF on HIV patient outcomes. ICF using a standardized TB screening/diagnostic strategy recently recommended by the WHO will be implemented for a longitudinal cohort of HIV patients in Uganda. TB case-detection and HIV/TB mortality rates will be assessed using a pre/post study design. 2) To determine the comparative- effectiveness of ICF algorithms that utilize new rapid TB diagnostic tools. We will evaluate the comparative accuracy of the urine LAM-ELISA, Lateral-Flow LAM, and Cepheid Xpert rapid diagnostic tests among TB suspects in Uganda. Decision-analysis will be used to estimate the accuracy, efficiency, and yield of ICF algorithms that incorporate combinations of these tools [with/without conventional diagnostics] either serially and/or in parallel. 2) To model the impact, costs, and cost-effectiveness of incorporating novel, rapid TB diagnostics into ICF algorithms. We will model the impact of novel ICF interventions on population TB incidence, prevalence, and mortality in HIV-prevalent regions, and perform an economic evaluation to guide cost-effective placement of novel, rapid TB diagnostics in the health system. Environment: Johns Hopkins University offers substantial intellectual and physical resources. The Division of Infectious Diseases has over 50 full-time faculty including leaders in international HIV and TB research. The JH Center for TB Research further provides a unique research infrastructure with multi-disciplinary faculty, extensive international partnerships, and over 5,500 square feet of new lab and office space. Johns Hopkins Public Health School is the largest such institution in the world and offers intensive coursework in all aspects of clinical research design, management, and analysis, including economic evaluation of health interventions. This comprehensive portfolio will facilitate development as an independent clinical investigator.

描述（由申请人提供）：我的长期目标是成为一名独立的研究人员，专注于新的，成本效益高的策略，用于检测和控制艾滋病毒和结核病（TB）。在获奖期间，我将建立在方法和临床调查，传染病建模和经济评估的行为的专业知识。我的职业发展计划将正式教学与解决全球艾滋病毒/结核病优先事项的相关研究经验相结合。一个由艾滋病毒/结核病研究领域公认的领导人组成的跨学科团队将在职业发展的这一阶段提供专业和科学的指导。研究：艾滋病毒患者中结核病和耐多药结核病的有效控制受到病例检出率低的阻碍。世卫组织提倡将结核病强化病例发现（ICF）作为艾滋病毒/结核病控制的一项战略，但存在严重的知识差距。首先，目前尚不清楚艾滋病毒患者结核病的ICF是否会增加病例发现率并降低艾滋病毒/结核病死亡率。其次，作为未来ICF算法的一部分，新兴的快速结核病诊断工具的最佳使用尚不清楚。最后，新型ICF干预措施的成本效益尚未阐明。本提案的目的是：1）确定标准化结核病ICF对艾滋病患者结局的影响。将对乌干达的艾滋病毒患者纵向队列实施使用世卫组织最近建议的标准化结核病筛查/诊断策略的ICF。将采用研究前/研究后设计评估结核病例检出率和艾滋病毒/结核病死亡率。2)确定使用新的结核病快速诊断工具的ICF算法的相对有效性。我们将在乌干达结核病疑似患者中评价尿液LAM-ELISA、侧向流LAM和Cepheid Xpert快速诊断检测试剂的比较准确性。决策分析将用于估计ICF算法的准确性、效率和产量，该算法将这些工具[有/无常规诊断]的组合串联和/或并联。2)模拟将新型快速结核病诊断纳入ICF算法的影响、成本和成本效益。我们将模拟新型ICF干预措施对艾滋病毒流行地区人口结核病发病率、患病率和死亡率的影响，并进行经济评估，以指导卫生系统中新型快速结核病诊断的成本效益。环境：约翰霍普金斯大学提供大量的智力和物质资源。传染病部门拥有50多名全职教师，包括国际艾滋病毒和结核病研究的领导者。JH结核病研究中心还提供了独特的研究基础设施，包括多学科教师，广泛的国际合作伙伴关系以及超过5，500平方英尺的新实验室和办公空间。约翰霍普金斯公共卫生学院是世界上最大的此类机构，并提供临床研究设计，管理和分析，包括健康干预措施的经济评估的各个方面的密集课程。这一全面的投资组合将促进发展为一个独立的临床研究者。