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

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.

Inclusion Criteria:

1. Age:

   • Adults aged 15 years and above
   • Young adolescents aged 10-14 years

2. Community setting:

   o Rural and urban poor, elderly, marginalized groups, internally displaced persons (IDP) in camps and host communities, nomadic communities, and contacts of people with TB who attend community-based case finding (CBCF) campaigns.

3. Screening eligibility:

   • Screen positive on CAD CXR-AI (CAD score threshold ≥ 0.3).

4. Consent:

   • Written informed consent (and assent for adolescents if recruited) must be obtained according to local ethics and regulatory requirements.

Exclusion Criteria:

1. Age o Below 10 years at enrolment

2. Screening eligibility

   o Do not screen positive with CAD CXR-AI (CAD score threshold <0.3).

3. Consent and follow-up

   o Unable or unwilling to provide written informed consent (and assent where applicable) or unwilling to agree to follow-up visits.

4. Current TB treatment

   o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.

5. Recent TB preventive therapy

   o Receipt of TB preventive therapy within the last 6 months prior to enrolment.

6. Clinical danger signs

   o Presence of severe illness at screening, including but not limited to:

   ▪ Respiratory rate >30/min St

   • Fever >39°C
   • Pulse rate >120/min
   • Inability to walk unaided

7. Duplicate enrolment o Previous enrolment in DARE-TB.