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NCT Number: NCT07420881

Start4All - Start Taking Action for TB Diagnosis (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.

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Key information

Conditions

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

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

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)

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.

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.

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.

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.

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).

    Time frame: 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

    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)

Secondary outcomes

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

    Time frame: 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

    WHO: Participants able to produce sputum; Participants unable to produce sputum and people with difficulty to produce sputum WHAT: Number and proportion of TB cases identified using NPOC oral swabs WHEN: At completion of diagnostic work-up (Day 1-3) WHERE: CBCF sites and referral laboratories in Bangladesh, Cameroon, and Nigeria WHY: To evaluate whether NPOC enables TB detection among individuals excluded from sputum-based diagnostics

    -

    HOW MEASURED:

    • Numerator = number of microbiologically confirmed TB cases identified by NPOC oral swab
    • Denominator =
    • total participants able to produce sputum;
    • total participants unable to produce sputum and with difficulty to produce sputum who were tested by NPOC oral swab
    • Case definitions = WHO TB definitions (microbiologically confirmed only, since clinical diagnosis is not an endpoint in DARE-TB)

  2. 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)

    Time frame: 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

    WHO: CBCF screening events WHAT: CBCF costs and outcomes WHEN: Collected alongside diagnostic procedures during CBCF activities WHERE: CBCF sites across Bangladesh, Cameroon, and Nigeria WHY: To estimate cost and cost-effectiveness

    HOW MEASURED:

    • Measure cost of community-based case finding through community-based events
    • Incremental cost per person diagnosed with TB of NPOC test from a societal perspective (i.e., provider and beneficiary) in community-based case-finding:
    • as a diagnostic test compared to LC-NAAT
    • comparing multiple screening algorithms that use CAD CXR-AI and/or W4SS as screening tests, and NPOC test or LC-NAAT as diagnostic test
    • As an exploratory analysis, we will consider the use of secondary modelling approaches to estimate downstream health economic outcomes such as disability-adjusted life years (DALYs). This analysis will be conducted using existing data only and will not require collection of any additional primary data beyond what is already s

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

    Time frame: 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

    WHO: Sub samples of participants, healthcare providers, and programme stakeholders

    WHAT: Feasibility & Acceptability:

    Feasibility (workload, logistics, integration into CBCF workflows) Acceptability (willingness, confidence, perceived burden) of NPOC swab testing

    WHEN: Collected alongside diagnostic procedures during CBCF activities

    WHERE: CBCF sites across Bangladesh, Cameroon, and Nigeria

    WHY: To understand whether NPOC can be practically and acceptably integrated into CBCF models at scale

    HOW MEASURED:

    o Mixed-methods evaluation (acceptability)

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

    Time frame: 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

    WHO: Sub samples of participants, healthcare providers, and programme stakeholders

    WHAT: Feasibility & Acceptability:

    Feasibility (workload, logistics, integration into CBCF workflows) Acceptability (willingness, confidence, perceived burden) of NPOC swab testing

    WHEN: Collected alongside diagnostic procedures during CBCF activities

    WHERE: CBCF sites across Bangladesh, Cameroon, and Nigeria

    WHY: To understand whether NPOC can be practically and acceptably integrated into CBCF models at scale

    HOW MEASURED:

    o Mixed-methods evaluation (FGDs, KIIs, structured observations, short questionnaires)

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

    Time frame: 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

    WHO: Sub samples of participants, healthcare providers, and programme stakeholders

    WHAT: Feasibility & Acceptability:

    Feasibility (workload, logistics, integration into CBCF workflows) Acceptability (willingness, confidence, perceived burden) of NPOC swab testing

    WHEN: Collected alongside diagnostic procedures during CBCF activities

    WHERE: CBCF sites across Bangladesh, Cameroon, and Nigeria

    WHY: To understand whether NPOC can be practically and acceptably integrated into CBCF models at scale

    HOW MEASURED:

    o Proportion of participants able/willing to self- or provider-swab successfully (number of participants who are willing to complete swab & of this percentage, how many conducted it successfully) (feasibility)

  6. Secondary Endpoint 3.3: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.

    Time frame: 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

    WHO: Sub samples of participants, healthcare providers, and programme stakeholders

    WHAT: Feasibility & Acceptability:

    Feasibility (workload, logistics, integration into CBCF workflows) Acceptability (willingness, confidence, perceived burden) of NPOC swab testing

    WHEN: Collected alongside diagnostic procedures during CBCF activities

    WHERE: CBCF sites across Bangladesh, Cameroon, and Nigeria

    WHY: To understand whether NPOC can be practically and acceptably integrated into CBCF models at scale

    HOW MEASURED:

    o Thematic analysis of acceptability (Sekhon framework) and feasibility (Klaic/Barker/French frameworks)

  7. Secondary Endpoint 4.1: Diagnostic yield of TB among participants using self-collected swabs compared with HCW-collected swabs

    Time frame: 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

    WHO: All participants (≥10 years) eligible for both self- and HCW-collected swabs.

    WHAT: Number and proportion of TB diagnoses from self-collected vs HCW-collected swabs.

    WHEN: At completion of diagnostic work-up (Day 1-3); confirmation via NTP register at treatment initiation.

    WHERE: Study healthcare facilities in all countries. WHY: To assess whether self-collection achieves comparable diagnostic yield to HCW collection.

    HOW MEASURED:

    The data analysis will use the datasets collected in each of the study countries: Bangladesh, Cameroon, and Nigeria. Analyses will be conducted both stratified by country, i.e. using on the dataset from the country, and using the aggregated data across the three countries. Analysis will consider:

    • Numerator = TB-positive results from each swab type.
    • Denominator = total attempted tests.
    • Stratification = symptomatic vs asymptomatic.

  8. Secondary Endpoint 4.2: Diagnostic accuracy of self-collected tongue swabs

    Time frame: 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

    WHO: Participants who completed self-swab and had individual results available. WHAT: Sensitivity, specificity, PPV, NPV of self-swabs relative to HCW-swabs as reference.

    WHEN: At completion of diagnostic work-up (Day 1-3); confirmation via NTP register at treatment initiation.

    WHERE: Study healthcare facilities in all countries. WHY: To assess whether self-collection achieves comparable diagnostic yield to HCW collection.

    HOW MEASURED: Standard accuracy metrics using HCW swabs and final diagnostic algorithm as reference.

  9. Secondary Endpoint 4.3: Diagnostic accuracy of HCW-collected tongue swabs

    Time frame: 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

    WHO: Participants who completed HCW-collected swab and had individual results available.

    WHAT: Sensitivity, specificity, PPV, NPV of self-swabs relative to HCW-swabs as reference.

    WHEN: At completion of diagnostic work-up (Day 1-3); confirmation via NTP register at treatment initiation.

    WHERE: Study healthcare facilities in all countries. WHY: To assess whether self-collection achieves comparable diagnostic yield to diagnostic reference standard.

    HOW MEASURED: Standard accuracy metrics for HCW swabs evaluated against diagnostic reference standard (MRS).

Sponsors and collaborators

Lead sponsor

Liverpool School of Tropical Medicine

Other

Collaborators

  • Centre for Control of Chronic Disease (CCCD),icddr,b
  • Comité National d'Ethique pour la Recherche en Santé Humaine
  • National Health Research Ethics Committee Nigeria

Registry information

Official study title

Start 4 All - DARE-TB

Acronym: S4A-DARE-TB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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