Loading clinical trials...
Loading clinical trials...
Start 4 All - DARE-TB
DARE-TB has been designed to address critical evidence gaps on the diagnostic performance and operational value of near point-of-care (NPOC) nucleic acid amplification tests (NAATs) within community-based case finding (CBCF) strategies. Although World Health Organization (WHO) recommends wider access to molecular testing, its use remains concentrated in facility-based settings well short of the global targets and largely dependent on sputum production. This creates a substantial diagnostic gap for people reached through community screening who either cannot provide sputum or whose sputum specimens cannot be tested on a NAAT at a facility, particularly for marginalized, hard-to-reach populations with poor access to healthcare.
By embedding NPOC swab testing into CBCF strategies in Bangladesh, Cameroon, and Nigeria, this study will generate: * Diagnostic accuracy estimates for NPOC among adults ≥15 years and young adolescents (10-14 years) identified through lung health camps after screening with CAD CXR-AI. * Direct evidence on NPOC use in non-sputum producers in community settings, addressing one of the most pressing gaps highlighted by WHO and national TB programmes. * Feasibility and acceptability insights on integrating NPOC into CBCF algorithms, complementing existing facility-based evidence. * Cost and cost-effectiveness estimate of using NPOC in CBCF. The findings will directly support future WHO guideline development and inform national programme decisions on incorporating NPOC assays into CBCF models to reach populations at greatest risk of being missed by sputum-based approaches.
Age
10 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
March 1, 2026
Primary Completion Date
March 1, 2027
Completion Date
October 1, 2027
Last Updated
February 19, 2026
60,000
ESTIMATED participants
Near point of care (NPOC) NAATs
DIAGNOSTIC_TEST
Low-complexity nucleic acid amplification tests (LC-NAATs)
DIAGNOSTIC_TEST
LC-NAAT using pooled testing
DIAGNOSTIC_TEST
Computer-Aided Detection (CAD) Chest X-ray (CXR-AI)
DIAGNOSTIC_TEST
Culture (reference standard)
DIAGNOSTIC_TEST
Sputum smear microscopy
DIAGNOSTIC_TEST
Lead Sponsor
Liverpool School of Tropical Medicine
Collaborators
NCT04700579
NCT06511180
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions