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

NCT07420881 | Not Yet Recruiting DMC

• 1 other identifier: 124
• Study Type: interventional
• Target: 60,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

TB - Tuberculosis

Keywords

TB; Diagnostics

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint: Diagnostic accuracy (sensitivity, specificity, PPV, NPV) of NPOC assays (tongue swab and sputum swab) compared against the microbiological reference standard (MRS: sputum culture).

  WHO: All participants with interpretable NPOC results WHAT: Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of NPOC oral and sputum swabs WHEN: Calculated after completion of reference standard testing (culture) WHERE: Central data analysis and across Bangladesh, Cameroon, and Nigeria WHY: To provide robust evidence of NPOC performance against the microbiological reference standard in CBCF settings HOW MEASURED: * Reference standard = culture * Accuracy estimates presented with 95% confidence intervals * Pre-specified handling of invalid/error results * Disaggregated by sample type (tongue vs sputum swab)

  The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027

Secondary Outcomes (9)

• Secondary Endpoint 1: Diagnostic Yield among Non-Sputum Producers and people with difficulty to produce sputum

  The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027

• Secondary Endpoint 2: cost and cost-effectiveness of NPOC diagnostics in community-based case-finding (CBCF) setting and diagnostic algorithms among adults (15 years and above) and young adolescents (10-14 years)

  The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027

• Secondary Endpoint 3.1: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.

  The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027

• Secondary Endpoint 3.1: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.

  The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027

• Secondary Endpoint 3.2: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.

  The overall duration of the DARE-TB Study is expected to be 12 months, beginning in Q2 2026 and concluding in Q2 2027. Recruitment, diagnostic testing, and follow-up will all occur between Q2 2026 and Q1 2027

Study Arms (1)

Diagnostic

OTHER

Diagnostic

Diagnostic Test: Near point of care (NPOC) NAATs; Diagnostic Test: Low-complexity nucleic acid amplification tests (LC-NAATs); Diagnostic Test: LC-NAAT using pooled testing; Diagnostic Test: Computer-Aided Detection (CAD) Chest X-ray (CXR-AI); Diagnostic Test: Culture (reference standard); Diagnostic Test: Sputum smear microscopy

Interventions

Near point of care (NPOC) NAATs DIAGNOSTIC_TEST

* Near point of care instrument that can test tongue swabs and sputum swabs\[6\]. * Rapid molecular detection system for detecting infectious diseases included TB, able to provide accurate test results that are comparable to top laboratory PCR tests, while it is easier to sue and move around and only takes 15 to 35 minutes to conclude the result. * Sample: Tongue swab or sputum swab (when sputum can be produced). * Processed directly on the near point-of-care device. * Results will be automatically generated by the device and recorded in the case report form (CRF).

Diagnostic

Low-complexity nucleic acid amplification tests (LC-NAATs) DIAGNOSTIC_TEST

* Semi-quantitative, nested real-time polymerase chain reaction (PCR) diagnostic test for the detection of Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples\[9, 10\]. It can also detect rifampicin-resistance associated mutations in MTB. Results are automatically displayed on the screen of the system in less than 80 minutes. * Sample: Performed on sputum specimens where sputum can be produced. * Results are available within 1-2 days depending on site capacity. Reported back to participants at the Day 2 visit (individual test result)

Diagnostic

LC-NAAT using pooled testing DIAGNOSTIC_TEST

Platform available at the health facility will be used to perform pooled testing (4, 8, 16 or 32 modules). Sample/Procedure: Pooled testing involves combining equal volumes from multiple individuals' samples and testing them together using a single test\[10\]. Pools will be created using remaining samples from 2-4 participants who have screened positive and were able to produce a sputum, guided by CAD CXR-AI thresholds\[11\]. To the possible extend, pools will be suggested by CAD band score: 0.3 ≤ CAD \< 0.8 pooled together. No pooled testing is required with CAD ≥ 0.8.

Diagnostic

Computer-Aided Detection (CAD) Chest X-ray (CXR-AI) DIAGNOSTIC_TEST

Computer-aided detection (CAD) software for chest X-rays is designed to support rapid, automated screening for tuberculosis and other thoracic abnormalities. Operating on mobile or computer platforms, these tools can analyse chest X-rays in less than a minute, distinguishing normal from abnormal scans and highlighting findings in the lungs, pleura, mediastinum, bones, diaphragm, and heart. In addition to detecting disease, some systems can assist clinicians with tasks such as verifying device placement and measuring distances from anatomical landmarks.

Diagnostic

Culture (reference standard) DIAGNOSTIC_TEST

The Mycobacterial Culture (solid or liquid, depending on country platform availability) is the gold-standard diagnostic test for tuberculosis. Culture detects viable Mycobacterium tuberculosis (MTB) organisms by growing them on selective media, allowing for confirmation of disease and, where relevant, downstream drug susceptibility testing (DST). Sample: Performed on sputum specimens where sputum can be produced. Turnaround time: Results are typically available within 2-8 weeks depending on the culture method (solid vs liquid) and laboratory capacity.

Diagnostic

Sputum smear microscopy DIAGNOSTIC_TEST

Sputum smear microscopy (Ziehl-Neelsen or fluorescent staining, depending on laboratory platform availability) is a conventional diagnostic method that detects Mycobacterium tuberculosis (MTB) through visualisation of acid-fast bacilli (AFB) under a microscope. While widely used, its sensitivity is limited, particularly in individuals with paucibacillary disease or those unable to produce quality sputum. Sample: Performed on sputum specimens where sputum can be produced. Turnaround time: As microscopy will be performed at referral laboratories (where culture is also conducted), results are typically available within several days to 1-2 weeks, depending on sample transport and laboratory processing schedules. Results are reported semi-quantitatively (Negative, Scanty, 1+, 2+, 3+) following WHO and national TB programme grading standards.

Diagnostic

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• 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

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MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Diagnosis, Computer-Assisted; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Diagnosis; Diagnostic Techniques and Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be available for a maximum of 5 years after study close
• Access Criteria: All requests for access to the IPD will be assessed by the Sponsor and must be agreed by all Data Controller organisations.