TB - TuberculosisS4A-DARE-TBNCT07420881

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

A study testing Near point of care (NPOC) NAATs, Low-complexity nucleic acid amplification tests (LC-NAATs) and LC-NAAT using pooled testing in people with TB - Tuberculosis, run by Liverpool School of Tropical Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

Trial summary

Who is it for?: Ages 10 years and older
Conditions the study is for: TB - Tuberculosis
What is being tested?: Near point of care (NPOC) NAATs, Low-complexity nucleic acid amplification tests (LC-NAATs) and LC-NAAT using pooled testing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60,000 participants
Where: No sites listed yet
Study dates: 1 Mar 2026to 1 Oct 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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:

Show all 9Show fewer

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.

Who cannot join

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

Show all 16Show fewer

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.

About this study

Official title: 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.

Read the detailed description

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.

Conditions: TB - Tuberculosis
Being tested: Near point of care (NPOC) NAATs, Low-complexity nucleic acid amplification tests (LC-NAATs), LC-NAAT using pooled testing, Computer-Aided Detection (CAD) Chest X-ray (CXR-AI), Culture (reference standard)
Keywords: TB, Diagnostics
Medical subject headings: Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Near point of care (NPOC) NAATsDiagnostic 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 testingDiagnostic 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 microscopyDiagnostic 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.

Study groups in NCT07420881
Study group	Role	What they receive
Diagnostic	Other	Diagnostic Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
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)
Measured: 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)
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
Measured: 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.
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:
- Mixed-methods evaluation (acceptability)
Measured: 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.
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:
- Mixed-methods evaluation (FGDs, KIIs, structured observations, short questionnaires)
Measured: 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.
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:
- 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)
Measured: 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 3.3: Feasibility & acceptability of NPOC from the perspective of people reached through CBCF and from the health system.
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:
- Thematic analysis of acceptability (Sekhon framework) and feasibility (Klaic/Barker/French frameworks)
Measured: 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 4.1: Diagnostic yield of TB among participants using self-collected swabs compared with HCW-collected swabs
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.
Measured: 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 4.2: Diagnostic accuracy of self-collected tongue swabs
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.
Measured: 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 4.3: Diagnostic accuracy of HCW-collected tongue swabs
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).
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20261 Oct 2027

First posted19 Feb 2026
Study start1 Mar 2026 (estimated)
Primary completion1 Mar 2027 (estimated)
Study completion1 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for TB - TuberculosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07420881
Sponsor's protocol ID: 124
Acronym: S4A-DARE-TB
Status last verified: Nov 2025
First submitted: 26 Nov 2025
Last updated: 19 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: At the end of the study, after the primary results have been published, the individual participant data (IPD) and associated documentation (e.g. protocol, statistical analysis plan, annotated blank CRF) will be prepared in order to be shared with external researchers. IPD will only be shared with external researchers if the participants have consented to this onward disclosure, IPD has been fully anonymised prior to sharing

Publications

Azam K, Cadir N, Madeira C, Gillespie SH, Sabiiti W. OMNIgene.SPUTUM suppresses contaminants while maintaining Mycobacterium tuberculosis viability and obviates cold-chain transport. ERJ Open Res. 2018 Feb 16;4(1):00074-2017. doi: 10.1183/23120541.00074-2017. eCollection 2018 Jan.
PubMed 29479537
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
PubMed 26511519
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
PubMed 28126032
French SD, Green SE, O'Connor DA, McKenzie JE, Francis JJ, Michie S, Buchbinder R, Schattner P, Spike N, Grimshaw JM. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci. 2012 Apr 24;7:38. doi: 10.1186/1748-5908-7-38.
PubMed 22531013
Barker PM, Reid A, Schall MW. A framework for scaling up health interventions: lessons from large-scale improvement initiatives in Africa. Implement Sci. 2016 Jan 29;11:12. doi: 10.1186/s13012-016-0374-x.
PubMed 26821910
Klaic M, Kapp S, Hudson P, Chapman W, Denehy L, Story D, Francis JJ. Implementability of healthcare interventions: an overview of reviews and development of a conceptual framework. Implement Sci. 2022 Jan 27;17(1):10. doi: 10.1186/s13012-021-01171-7.
PubMed 35086538
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686
Datta S, Shah L, Gilman RH, Evans CA. Comparison of sputum collection methods for tuberculosis diagnosis: a systematic review and pairwise and network meta-analysis. Lancet Glob Health. 2017 Aug;5(8):e760-e771. doi: 10.1016/S2214-109X(17)30201-2. Epub 2017 Jun 15.
PubMed 28625793
Codlin AJ, Vo LNQ, Garg T, Banu S, Ahmed S, John S, Abdulkarim S, Muyoyeta M, Sanjase N, Wingfield T, Iem V, Squire B, Creswell J. Expanding molecular diagnostic coverage for tuberculosis by combining computer-aided chest radiography and sputum specimen pooling: a modeling study from four high-burden countries. BMC Glob Public Health. 2024;2(1):52. doi: 10.1186/s44263-024-00081-2. Epub 2024 Aug 1.
PubMed 39100507
Iem V, Byrne RL, Garg T, Santos V, Yassin MA, Kathure I, Donkeng Donfack VF, Vuchas C, Bilder CR, Creswell J, Squire SB, Wingfield T. Pooled testing for TB: revisiting a cost-saving innovation. Lancet Respir Med. 2025 Nov;13(11):958-961. doi: 10.1016/S2213-2600(25)00328-5. Epub 2025 Sep 25. No abstract available.
PubMed 41016409
Kohli M, Inbaraj LR, Salomon A, Scandrett K, Korobitsyn A, Ismail N, Srinivasalu VA, Daniel J, Steingart KR, Takwoingi Y. Low-complexity automated nucleic acid amplification tests for extrapulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Aug 4;8(8):CD012768. doi: 10.1002/14651858.CD012768.pub4.
PubMed 40757508
WHO consolidated guidelines on tuberculosis: Module 2: screening - systematic screening for tuberculosis disease [Internet]. Geneva: World Health Organization; 2021. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK569338/
PubMed 33822560
Qin ZZ, Naheyan T, Ruhwald M, Denkinger CM, Gelaw S, Nash M, Creswell J, Kik SV. A new resource on artificial intelligence powered computer automated detection software products for tuberculosis programmes and implementers. Tuberculosis (Edinb). 2021 Mar;127:102049. doi: 10.1016/j.tube.2020.102049. Epub 2021 Jan 4.
PubMed 33440315
Steadman A, Kumar KM, Asege L, Kato-Maeda M, Mukwatamundu J, Shah K, Trang T, Ball A, Khimani K, Kim Dung DT, Michael JS, Christopher DJ, Phan H, Yerlikaya S, Nahid P, Denkinger CM, Cattamanchi A, Andama A. Diagnostic accuracy of swab-based molecular tests for tuberculosis using near-point-of-care platforms: a multi-country evaluation. EBioMedicine. 2025 Nov;121:105991. doi: 10.1016/j.ebiom.2025.105991. Epub 2025 Oct 31.
PubMed 41175672
Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, Lesosky M, Bara W, Mungofa S, Pai M, Hoelscher M, Dowdy D, Pym A, Mwaba P, Mason P, Peter J, Dheda K; TB-NEAT team. Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet. 2014 Feb 1;383(9915):424-35. doi: 10.1016/S0140-6736(13)62073-5. Epub 2013 Oct 28.
PubMed 24176144

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis

All TB - Tuberculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Start 4 All - DARE-TB
ClinicalTrials.gov ID: NCT07420881
Acronym / sponsor ID: S4A-DARE-TB / 124
Conditions: TB - Tuberculosis
Keywords: TB, Diagnostics
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60,000 participants (estimated)
Lead sponsor: Liverpool School of Tropical MedicineUniversity, hospital or 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
Study start: 1 Mar 2026 (estimated)
Primary completion: 1 Mar 2027 (estimated)
Study completion: 1 Oct 2027 (estimated)
First posted: 19 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic	Other	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 microscopyDiagnostic

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Age:
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:
Consent:

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Near point of care (NPOC) NAATs* 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 test	Diagnostic
Low-complexity nucleic acid amplification tests (LC-NAATs)* 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 test	Diagnostic
LC-NAAT using pooled testingPlatform 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 test	Diagnostic
Computer-Aided Detection (CAD) Chest X-ray (CXR-AI)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 test	Diagnostic
Culture (reference standard)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 test	Diagnostic
Sputum smear microscopySputum 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 test	Diagnostic

Primary outcome

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)

9 secondary outcomes

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
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
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
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
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
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
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
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
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
Background: PubMed 29479537Azam K, Cadir N, Madeira C, Gillespie SH, Sabiiti W. OMNIgene.SPUTUM suppresses contaminants while maintaining Mycobacterium tuberculosis viability and obviates cold-chain transport. ERJ Open Res. 2018 Feb 16;4(1):00074-2017. doi: 10.1183/23120541.00074-2017. eCollection 2018 Jan.
Background: PubMed 26511519Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
Background: PubMed 28126032Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
Background: PubMed 22531013French SD, Green SE, O'Connor DA, McKenzie JE, Francis JJ, Michie S, Buchbinder R, Schattner P, Spike N, Grimshaw JM. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci. 2012 Apr 24;7:38. doi: 10.1186/1748-5908-7-38.
Background: PubMed 26821910Barker PM, Reid A, Schall MW. A framework for scaling up health interventions: lessons from large-scale improvement initiatives in Africa. Implement Sci. 2016 Jan 29;11:12. doi: 10.1186/s13012-016-0374-x.
Background: PubMed 35086538Klaic M, Kapp S, Hudson P, Chapman W, Denehy L, Story D, Francis JJ. Implementability of healthcare interventions: an overview of reviews and development of a conceptual framework. Implement Sci. 2022 Jan 27;17(1):10. doi: 10.1186/s13012-021-01171-7.
Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Background: PubMed 28625793Datta S, Shah L, Gilman RH, Evans CA. Comparison of sputum collection methods for tuberculosis diagnosis: a systematic review and pairwise and network meta-analysis. Lancet Glob Health. 2017 Aug;5(8):e760-e771. doi: 10.1016/S2214-109X(17)30201-2. Epub 2017 Jun 15.
Background: PubMed 39100507Codlin AJ, Vo LNQ, Garg T, Banu S, Ahmed S, John S, Abdulkarim S, Muyoyeta M, Sanjase N, Wingfield T, Iem V, Squire B, Creswell J. Expanding molecular diagnostic coverage for tuberculosis by combining computer-aided chest radiography and sputum specimen pooling: a modeling study from four high-burden countries. BMC Glob Public Health. 2024;2(1):52. doi: 10.1186/s44263-024-00081-2. Epub 2024 Aug 1.
Background: PubMed 41016409Iem V, Byrne RL, Garg T, Santos V, Yassin MA, Kathure I, Donkeng Donfack VF, Vuchas C, Bilder CR, Creswell J, Squire SB, Wingfield T. Pooled testing for TB: revisiting a cost-saving innovation. Lancet Respir Med. 2025 Nov;13(11):958-961. doi: 10.1016/S2213-2600(25)00328-5. Epub 2025 Sep 25. No abstract available.
Background: PubMed 40757508Kohli M, Inbaraj LR, Salomon A, Scandrett K, Korobitsyn A, Ismail N, Srinivasalu VA, Daniel J, Steingart KR, Takwoingi Y. Low-complexity automated nucleic acid amplification tests for extrapulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Aug 4;8(8):CD012768. doi: 10.1002/14651858.CD012768.pub4.
Background: PubMed 33822560WHO consolidated guidelines on tuberculosis: Module 2: screening - systematic screening for tuberculosis disease [Internet]. Geneva: World Health Organization; 2021. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK569338/
Individual participant dataSharing planned: Yes. At the end of the study, after the primary results have been published, the individual participant data (IPD) and associated documentation (e.g. protocol, statistical analysis plan, annotated blank CRF) will be prepared in order to be shared with external researchers. IPD will only be shared with external researchers if the participants have consented to this onward disclosure, IPD has been fully anonymised prior to sharing

Related trials for TB - Tuberculosis

RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07420881, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.