Start4All - Start Taking Action for TB Diagnosis (DARE-TB)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorLiverpool School of Tropical Medicine

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

60,000 Participants
are divided into 1 treatment group

Locations

This trial has no 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