Start4All - Start Taking Action for TB Diagnosis (DARE-TB) (S4A-DARE-TB)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TB - Tuberculosis
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 60000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age:

   • Adults aged 15 years and above
   • Young adolescents aged 10-14 years

2. 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.

3. Screening eligibility:

   • Screen positive on CAD CXR-AI (CAD score threshold ≥ 0.3).

4. Consent:

   • Written informed consent (and assent for adolescents if recruited) must be obtained according to local ethics and regulatory requirements.

Exclusion Criteria:

1. Age o Below 10 years at enrolment

2. Screening eligibility

   o Do not screen positive with CAD CXR-AI (CAD score threshold <0.3).

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.

4. Current TB treatment

   o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.

5. Recent TB preventive therapy

   o Receipt of TB preventive therapy within the last 6 months prior to enrolment.

6. 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
7. Duplicate enrolment o Previous enrolment in DARE-TB.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Diagnostic

Diagnostic test: 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: 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: LC-NAAT using pooled testing; 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 test: 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: 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: Sputum smear microscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	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: 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)	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-NAATcomparing 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	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: Numerator = TB-positive results from each swab type.; Denominator = total attempted tests.; Stratification = symptomatic vs asymptomatic.	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

Collaborators and Investigators

• Sponsor: Liverpool School of Tropical Medicine
• 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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/
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: TB; Diagnostics
• Additional Relevant MeSH Terms: Latent Infection; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Latent Tuberculosis; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnosis, Computer-Assisted
• Other Study ID Numbers: 124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: IPD will be available for a maximum of 5 years after study close
• IPD Sharing Access Criteria: All requests for access to the IPD will be assessed by the Sponsor and must be agreed by all Data Controller organisations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No