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

Starting soon · Not applicable

Conditions studied: TB - Tuberculosis

In brief

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.

Key facts

Study ID

NCT07420881

Run by

Liverpool School of Tropical Medicine

People needed

60000

Starts

2026-03-01

Expected to finish

2027-10-01

Last updated by the study team

2026-02-19

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age:
• Adults aged 15 years and above
• Young adolescents aged 10-14 years
• 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.
• Screening eligibility:
• Screen positive on CAD CXR-AI (CAD score threshold ≥ 0.3).
• Consent:
• Written informed consent (and assent for adolescents if recruited) must be obtained according to local ethics and regulatory requirements.

You may not qualify if…

• Age o Below 10 years at enrolment
• Screening eligibility
• o Do not screen positive with CAD CXR-AI (CAD score threshold <0.3).
• 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.
• Current TB treatment
• o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.
• Recent TB preventive therapy
• o Receipt of TB preventive therapy within the last 6 months prior to enrolment.
• 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
• Duplicate enrolment o Previous enrolment in DARE-TB.

Full record on ClinicalTrials.gov

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