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Novel clinic-based TB diagnostics and testing algorithms for persons with HIV

针对艾滋病毒感染者的基于临床的新型结核病诊断和检测算法

基本信息

批准号：
10359215
负责人：
ADRIENNE E SHAPIRO
金额：
$ 18.68万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-03-20 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10359215
关键词：
Address Adopted Adult Africa Africa South of the Sahara Algorithms Biological Assay Body mass index CD4 Lymphocyte Count Caring Classification Clinic Clinical Clinical Research Consumption Cost Analysis Data Store Decision Analysis Detection Diagnosis Diagnostic Diagnostic tests Epidemiologic Methods Epidemiology Equipment Evaluation Foundations Generations Goals HIV HIV/TB Health Hospitals Impact evaluation In Vitro Inpatients Laboratories Mentored Patient-Oriented Research Career Development Award Mentors Mentorship Modeling Morbidity - disease rate Outpatients Patient Dropouts Patient Selection Patients Performance Peripheral Persons Physicians Population Positioning Attribute Property Randomized Controlled Trials Research Research Institute Resource-limited setting Rural Science Scientist Services South Africa Specificity Specimen Sputum Symptoms Testing Time Training Training Programs Translating Tuberculosis Tuberculosis diagnosis Urine Validation World Health Organization base budget impact care seeking career clinically relevant cohort cost diagnostic accuracy diagnostic algorithm diagnostic strategy economic evaluation effective intervention epidemiology study evaluation/testing follow-up health economics implementation science implementation strategy improved infectious disease model innovation lipoarabinomannan meetings microcosting minimal risk mortality mycobacterial next generation novel novel diagnostics point of care point of care testing predictive modeling primary outcome prospective regression trees rural South Africa screening secondary outcome skills standard of care tool transmission process tuberculosis diagnostics tuberculosis treatment uptake validation studies

项目摘要

PROJECT SUMMARY/ABSTRACT Tuberculosis (TB) is the leading cause of mortality in people with HIV (PWH) in sub-Saharan Africa, due in part to delays in diagnosis and timely treatment. While HIV-infected persons often first seek care at peripheral clinics, TB diagnostic testing equipment located in centralized laboratories require time-consuming specimen transport and processing, resulting in delayed diagnosis and patient drop-out from care. Use of a point-of-care urine-based test detecting mycobacterial lipoarabinomannan (LAM) has been successful in reducing mortality in a hospital setting, but the existing test is insensitive in ambulatory patients. The largest burden of undiagnosed TB is in PWH in non-hospital settings, and clinic-based testing assays and improved algorithms are urgently needed. A promising novel, rapid, urine-based tests (nuLAM) has been developed that may overcome many barriers to TB diagnosis, but has not yet been tested in a clinical setting. My central hypothesis is that rational use of next- generation POC LAM testing will be an effective intervention for PWH in South Africa. I will test this hypothesis with the following specific aims: 1) To develop an optimized clinical algorithm to identify HIV-infected outpatients for TB testing using POC uLAM and guide evaluation of nuLAM. 2) To determine the diagnostic accuracy of the next-generation LAM tests to detect TB in a population of HIV-infected outpatients attending a rural clinic in South Africa, compared to rigorous validation standards of TB culture and GeneXpert. 3) To estimate the population-level impact of nuLAM testing of outpatient PWH through costing and decision analysis. My career goal is to become a physician-scientist with a focus on developing and implementing diagnostic approaches to ultimately reduce morbidity and mortality from HIV-associated TB. I will use the opportunity of the K23 award to obtain mentorship in predictive modeling, implementation science, and diagnostics science. These skills are highly complementary to my strong background in epidemiologic methods and clinical research, and will enable me to translate epidemiologic research findings into tools to help clinicians and policymakers improve approaches to TB diagnosis. At the completion of the research and mentoring outlined, I will be well-positioned to launch an independent research career with the ultimate goal of improving diagnosis, treatment, and care of HIV-associated TB in sub-Saharan Africa.

项目总结/文摘