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| Name | Class |
|---|---|
| Centre for Control of Chronic Disease (CCCD),icddr,b | UNKNOWN |
| Comité National d'Ethique pour la Recherche en Santé Humaine | UNKNOWN |
| National Health Research Ethics Committee Nigeria | UNKNOWN |
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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.
By embedding NPOC swab testing into CBCF strategies in Bangladesh, Cameroon, and Nigeria, this study will generate:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic | Other | Diagnostic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near point of care (NPOC) NAATs | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
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:
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:
â–ª Respiratory rate >30/min St
Duplicate enrolment o Previous enrolment in DARE-TB.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29479537 | Background | 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. | |
| 26511519 | Background | 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. |
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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
IPD will be available for a maximum of 5 years after study close
All requests for access to the IPD will be assessed by the Sponsor and must be agreed by all Data Controller organisations.
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|
| Low-complexity nucleic acid amplification tests (LC-NAATs) | Diagnostic Test |
|
|
| 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. |
|
| 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:
| 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: o Mixed-methods evaluation (acceptability) | 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: o Mixed-methods evaluation (FGDs, KIIs, structured observations, short questionnaires) | 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: 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) | 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: o Thematic analysis of acceptability (Sekhon framework) and feasibility (Klaic/Barker/French frameworks) | 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:
| 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. | 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). | 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 |
| 28126032 | Background | 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. |
| 22531013 | Background | 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. |
| 26821910 | Background | 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. |
| 35086538 | Background | 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. |
| 18929686 | Background | 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. |
| 28625793 | Background | 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. |
| 39100507 | Background | 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. |
| 41016409 | Background | 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. |
| 40757508 | Background | 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. |
| 33822560 | Background | 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/ |
| 33440315 | Background | 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. |
| 41175672 | Background | 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. |
| 24176144 | Background | 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. |
| 39681899 | Background | MacPherson P, Shanaube K, Phiri MD, Rickman HM, Horton KC, Feasey HRA, Corbett EL, Burke RM, Rangaka MX. Community-based active-case finding for tuberculosis: navigating a complex minefield. BMC Glob Public Health. 2024 Feb 8;2(1):9. doi: 10.1186/s44263-024-00042-9. |
| 39382418 | Background | Gupta-Wright A, Denkinger CM. Advances in TB diagnostics: A critical element for the elimination toolkit. Indian J Med Res. 2024 May;159(5):391-394. doi: 10.25259/IJMR_261_2024. No abstract available. |
| 40674508 | Background | Andrews JR, Kendall EA, Cattamanchi A, Denkinger CM, Nahid P, Shrestha S, Marx FM, Dowdy D, Hermans S, Cobelens F. Projecting the Impact and Costs of Near Point-of-Care Tuberculosis Screening Assays in Community-based Active Case Finding. Clin Infect Dis. 2025 Nov 6;81(4):776-784. doi: 10.1093/cid/ciaf395. |
| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
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| ID | Term |
|---|---|
| D003936 | Diagnosis, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D003933 | Diagnosis |
| D019937 | Diagnostic Techniques and Procedures |
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