About this trial
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.
Eligibility criteria
Qualifiers
Adults aged 15 years and above
Young adolescents aged 10-14 years
Screen positive on CAD CXR-AI (CAD score threshold ≥ 0.3).
Written informed consent (and assent for adolescents if recruited) must be obtained according to local ethics and regulatory requirements.
Disqualifiers
Age o Below 10 years at enrolment
Screening eligibility
Consent and follow-up
Current TB treatment
Trial design
Treatments tested in this trial
- Near point of care (NPOC) NAATs
- Low-complexity nucleic acid amplification tests (LC-NAATs)
- LC-NAAT using pooled testing
- Computer-Aided Detection (CAD) Chest X-ray (CXR-AI)
- Culture (reference standard)
- Sputum smear microscopy
Treatment groups
Locations
Sponsors and collaborators
Liverpool School of Tropical Medicine
Lead sponsor
Centre for Control of Chronic Disease (CCCD),icddr,b
Collaborator
Comité National d'Ethique pour la Recherche en Santé Humaine
Collaborator
National Health Research Ethics Committee Nigeria
Collaborator