NCT07420881Not yet recruiting
Start4All - Start Taking Action for TB Diagnosis (DARE-TB)
Start 4 All - DARE-TB
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60000 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Liverpool School of Tropical Medicine
- Diseases
- Tuberculosis
- NCT number
- NCT07420881
What you commit to
- Study type: Interventional
- Planned participants: 60000
- From 1 Mar 2026 to the primary completion date, 1 Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Duplicate enrolment o Previous enrolment in DARE-TB.
Other illness
- 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
Age
- Age o Below 10 years at enrolment
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 10 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.