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Tuberculosis (TB) remains the leading cause of death from a single infectious agent globally, with millions of people still undiagnosed or diagnosed late. Conventional case-finding strategies rely heavily on symptom screening using the WHO Four-Symptom Screen ((W4SS; comprising any one of current cough, fever, night sweats, or weight loss) and sputum testing, but these approaches miss a substantial proportion of individuals with active TB disease, particularly those who are asymptomatic or unable to produce sputum. Missed and delayed diagnoses drive ongoing transmission and undermine global TB elimination goals.
Recent evidence has shown that diagnostic tools which are more accessible, even if somewhat less sensitive, can still substantially improve TB case detection by reducing diagnostic loss associated with access barriers. This suggests that near point-of-care (NPOC) tests might be highly cost-effective in many settings, because the gains from earlier diagnosis, reduced delays, and broader reach could outweigh losses from slightly lower accuracy.
The purpose of this study is to evaluate new, symptom-agnostic screening and diagnostic approaches that can be implemented at lower-level health facilities in high TB-burden, low and middle-income (LMIC) countries for adults ≥15 years and 10-14 years old young adolescents
The study will generate evidence on the performance, cost-effectiveness, feasibility, acceptability, and scalability of symptom-agnostic algorithms initiated by of computer-aided detection chest radiography (CAD CXR-AI) and near point-of-care (NPOC) molecular assays applied to tongue and sputum swabs. These tools have the potential to identify TB earlier, including among asymptomatic individuals, and to reduce dependence on sputum-based diagnostics alone.
The research questions being addressed are of direct global relevance. There is currently limited real-world evidence on: how CAD CXR-AI and NPOC tongue swab and sputum swab assays compare as initial screening tools; how they can be integrated with WHO-recommended low-complexity nucleic acid amplification tests (LC-NAATs), in efficient algorithms; and whether these approaches can be delivered effectively in primary care and outpatient settings in high TB burden LMIC. Data generated through this study will directly inform WHO guideline development and national TB programme decisions, especially concerning the detection of asymptomatic TB and the role of non-sputum samples.
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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 Objective 1: To evaluate the diagnostic yield and comparative accuracy of diagnostic algorithms initiated by CAD CXR-AI and/or NPOC tongue swab and sputum swab screening as initial screening tools in a facility-based case finding strategy | Primary Endpoint 1.1: Diagnostic Yield of TB by algorithm, disaggregated by symptom status
oNumerator = number of TB cases identified; oDenominator = total participants screened by each algorithm (including those with invalid and inconclusive results); oStratification = symptomatic vs asymptomatic (per WHO 4-symptom screen); oCase definitions = WHO TB definitions (microbiologically confirmed, clinicaly diagnose | Completed within 6 month of data collection |
| Primary Objective 1: To evaluate the diagnostic yield and comparative accuracy of diagnostic algorithms initiated by CAD CXR-AI and/or NPOC tongue swab and sputum swab screening as initial screening tools in a facility-based case finding strategy | Primary Endpoint 1.2: Comparative diagnostic accuracy (sensitivity, specificity, PPV, NPV) of (i) CAD CXR-AI as an initial screening tool, (ii) NPOC tongue swab and sputum swab testing as initial screening tools.
| Completed within 6 month of data collection |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Objective 1: To assess timeliness (time to treatment initiation) and proportion initiated on treatment, of CAD CXR-AI and/or NPOC tongue swab and sputum swab -based initiated algorithms | Secondary Endpoint 1.1: Time from entering healthcare facility to being initiated on TB treatment according to National TB Programme (NTP) register record
|
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory objective (SCREEN-TB & HIV substudy) To assess added diagnostic value of newer ultra-sensitive LAM tests (Biopromic and Plasmonic Fluor LAM RDT) among people living with HIV | Exploratory Endpoint 1.1: Incremental TB cases detected using newer ultra-sensitive LAM vs. Alere LAM and vs no use of LAM testing among HIV positive patients
|
Inclusion Criteria:
Age
Facility setting
o Participating healthcare facilities (e.g., primary health centres, district hospitals), including both rural and urban facilities.
Screening eligibility
o All individuals presenting to the facility, regardless of symptoms or ability to produce sputum, will be eligible for inclusion.
Consent
Exclusion Criteria:
Age
o Below 10 years at enrolment
Screening eligibility
o Do not screen positive on any tools.
Consent and follow-up
o Unable or unwilling to provide written informed consent (and assent where applicable) or unwilling to agree to follow-up visits.
Current TB treatment
o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.
Recent TB preventive therapy
o Receipt of TB preventive therapy within the last 6 months prior to enrolment.
Clinical danger signs
o Presence of severe illness at screening, including but not limited to: Respiratory rate >30/min Fever >39°C Pulse rate >120/min Inability to walk unaided
Duplicate enrolment o Previous enrolment in SCREEN-TB.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucy Read, BA | Contact | +44 (0)151 705 3715 | start4all@lstmed.ac.uk | |
| Vibol Lem, PhD | Contact | vibol.lem@lstmed.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Tom Wingfield, PhD FRCP DTMH DipHIV | Liverpool School of Tropical Medicine | Study Director |
| Vibol Lem, PhD | Liverpool School of Tropical Medicine | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39884504 | Background | David A, Singh L, Peloakgosi-Shikwambani K, Nsingwane Z, Molepo V, Cangelosi G, da Silva P, Stevens W, Scott L. Diagnostic accuracy of self-collected tongue swabs for Mycobacterium tuberculosis complex detection in individuals being assessed for tuberculosis in South Africa using the Xpert MTB/RIF Ultra assay. Clin Microbiol Infect. 2025 Jun;31(6):1040-1045. doi: 10.1016/j.cmi.2025.01.029. Epub 2025 Jan 28. | |
| 33306694 |
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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 | Semi-quantitative, nested real-time polymerase chain reaction (PCR) diagnostic test for the detection of Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples[18]. 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 |
|
| LC-NAAT using pooled testing | Diagnostic Test | Pooled testing involves combining equal volumes from multiple individuals' samples and testing them together using a single test[. 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[20]. To the possible extend, pools will be suggested by CAD band score: CAD <0.3 pooled together and 0.3 ≤ CAD < 0.8 pooled together.](streamdown:incomplete-link) |
|
| Portable Chest X-ray Image Acquisition | Diagnostic Test | Portable X-ray systems are designed to bring diagnostic imaging to environments where conventional radiography is impractical. They are lightweight, compact, and battery-powered, making them suitable for use in remote or resource-limited settings, or for reaching people with limited mobility. Depending on the model, they can produce between 100 and 400 images on a full charge, allowing extended use without access to electricity. |
|
| 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. Software for the study has not been selected yet. It will be a WHO-approved CAD software with final selection through tender processes and in compliance with national regulatory approvals. 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. |
|
| Screen TB&HIV sub-study diagnostic test | Other | The SCREEN TB&HIV substudy is implemented only in Cameroon, Nigeria and Kenya. HIV testing will therefore not be conducted in Bangladesh or Viet Nam, as HIV testing is not part of routine care pathways at the participating facilities and the study does not introduce additional HIV testing. In addition, Bangladesh and Viet Nam have substantially lower HIV prevalence, making implementation of the HIV substudy operationally unnecessary and not aligned with clinical need |
|
| Screen TB&HIV sub-study diagnostic test | Other | The CD4 cell count is performed in venous blood in HIV positive patients to assess progression of HIV disease, including risk for developing opportunistic infections. The normal range of CD4 count is from 500 to 1500 cells/mm3 of blood, and it progressively decreases over time in persons who are not receiving or not responding well to ART. Someone with a CD4 count below 200 is described as having advanced HIV disease. |
|
| Screen TB&HIV sub-study diagnostic test | Other | LAM is a glycolipid of the cell wall of Mycobacterium tuberculosis. LAM is excreted in urine, where it can be detected using rapid lateral flow tests. In inpatient settings, WHO strongly recommends using LAM to assist in the diagnosis of active TB in HIV-positive adults, adolescents and children with signs and symptoms of TB (pulmonary and/or extrapulmonary), or with advanced HIV disease (1) or who are seriously ill (2) or else irrespective of signs and symptoms of TB and with a CD4 cell count of less than 200 cells/mm3[23]. In outpatient settings, WHO suggests using LF-LAM to assist in the diagnosis of active TB in HIV-positive adults, adolescents and children: with signs and symptoms of TB (pulmonary and/or extrapulmonary) or seriously ill; or else irrespective of signs and symptoms of TB and with a CD4 cell count of less than 100 cells/mm3[23]. LAM tests evaluated in SCREEN TB&HIV are: |
|
| Completed within 6 month of data collection |
| Secondary Objective 1: To assess timeliness (time to treatment initiation) and proportion initiated on treatment, of CAD CXR-AI and/or NPOC tongue swab and sputum swab -based initiated algorithms | Secondary Endpoint 1.2: Proportion of individuals screening positive on the diagnostic algorithm who then initiate TB treatment.
| Completed within 6 month of data collection |
| Secondary Objective 2: To evaluate the cost-effectiveness of CAD CXR-AI and NPOC tongue swab and sputum swab as initial screening tools in facility-based case finding | Secondary Endpoint 2.1: Modelled incremental cost per person diagnosed with TB from a societal perspective (disaggregated by provider and beneficiary), comparing multiple screening and diagnostic algorithms where: CAD CXR-AI and NPOC are incorporated as initial screening tests Varying CAD thresholds for determining whether pooled or individual LC-NAAT testing is subsequently used are treated as independent and separate initial CAD CXR-AI screening tests
| Completed within 6 month of data collection |
| Secondary Objective 2: To evaluate the cost-effectiveness of CAD CXR-AI and NPOC tongue swab and sputum swab as initial screening tools in facility-based case finding | Secondary Endpoint 2.2: Modelled incremental cost per person diagnosed with TB who initiates treatment from a societal perspective (disaggregated by provider and beneficiary), comparing multiple screening and diagnostic algorithms where: CAD CXR-AI and NPOC are incorporated as initial screening tests Varying CAD thresholds for determining whether pooled or individual LC-NAAT testing is subsequently used are treated as independent and separate initial CAD CXR-AI screening tests
| Completed within 6 month of data collection |
| Secondary Objective 3: To evaluate feasibility, acceptability, and scalability of CAD CXR-AI and NPOC tongue swab and sputum swab in routine facility workflows | Secondary Endpoint 3.1: Feasibility and acceptability of CAD CXR-AI and NPOC tongue swab and sputum swab from diverse perspectives including people seeking care, and health system, and policy makers
| Completed within 6 month of data collection |
| Secondary Objective 4: To evaluate the diagnostic performance, efficiency, and feasibility of CAD-guided pooling compared with individual testing | Secondary Endpoint 4.1: Sensitivity and specificity of CAD-guided pooling relative to individual testing
| Completed within 6 month of data collection |
| Secondary Objective 4: To evaluate the diagnostic performance, efficiency, and feasibility of CAD-guided pooling compared with individual testing | Secondary Endpoint 4.2: Proportion of tests saved and associated change in turnaround time
| Completed within 6 month of data collection |
| Secondary Objective 4: To evaluate the diagnostic performance, efficiency, and feasibility of CAD-guided pooling compared with individual testing | Secondary Endpoint 4.3: Feasibility and acceptability of CAD-guided pooling from perspectives of laboratory staff, providers, and policymakers
| Completed within 6 months of data collection |
| Completed within 6 month of data collection |
| Exploratory objective (SCREEN-TB & HIV substudy) To assess added diagnostic value of newer ultra-sensitive LAM tests (Biopromic and Plasmonic Fluor LAM RDT) among people living with HIV | Exploratory Endpoint 1.2: Sensitivity and specificity of the ultra-sensitive LAM vs. Alere LAM (comparator) and of ultra-sensitive LAM compared to LC-NAAT-based reference standard
| Completed within 6 month of data collection |
| Exploratory objective (SCREEN-TB & HIV substudy) To assess added diagnostic value of newer ultra-sensitive LAM tests (Biopromic and Plasmonic Fluor LAM RDT) among people living with HIV | Exploratory Endpoint 1.3: Error/invalid rates; ease-of-use.
| Completed within 6 month of data collection |
| Exploratory objective (SCREEN-TB & HIV substudy) To assess added diagnostic value of newer ultra-sensitive LAM tests (Biopromic and Plasmonic Fluor LAM RDT) among people living with HIV | Exploratory Endpoint 1.4: Cost per additional case detected;
| Completed within 6 month of data collection |
| Exploratory objective Pooling of Tongue Swabs and Sputum Swabs Sub-study Exploratory Objective 2: To evaluate the diagnostic yield, accuracy, and efficiency of pooled versus individual testing of tongue swabs and sputum swabs using NPOC | Exploratory Endpoint 2.1: Diagnostic yield of TB from pooled tongue swabs versus individual tongue swabs
| Completed within 6 month of data collection |
| Exploratory objective Pooling of Tongue Swabs and Sputum Swabs Sub-study Exploratory Objective 2: To evaluate the diagnostic yield, accuracy, and efficiency of pooled versus individual testing of tongue swabs and sputum swabs using NPOC | Exploratory Endpoint 2.2: Diagnostic yield of TB from pooled tongue swabs versus individual sputum swabs
| Completed within 6 month of data collection |
| Exploratory objective Pooling of Tongue Swabs and Sputum Swabs Sub-study Exploratory Objective 2: To evaluate the diagnostic yield, accuracy, and efficiency of pooled versus individual testing of tongue swabs and sputum swabs using NPOC | Exploratory Endpoint 2.3: Comparative diagnostic accuracy (sensitivity, specificity, PPV, NPV) of tongue vs sputum pooling
| Within 6 months of data collection |
| Exploratory objective Pooling of Tongue Swabs and Sputum Swabs Sub-study Exploratory Objective 2: To evaluate the diagnostic yield, accuracy, and efficiency of pooled versus individual testing of tongue swabs and sputum swabs using NPOC | Exploratory Endpoint 2.4: Invalid or error rate of pooled vs individual testing
| Within 6 months of data collection |
| Exploratory objective Pooling of Tongue Swabs and Sputum Swabs Sub-study Exploratory Objective 2: To evaluate the diagnostic yield, accuracy, and efficiency of pooled versus individual testing of tongue swabs and sputum swabs using NPOC | Exploratory Endpoint 2.5: Efficiency outcomes (tests saved, cartridge use, estimated cost savings)
| Within 6 months of data collection |
| Exploratory objective Self-Swab Sub-study Exploratory Objective 3: Comparison between Provider-collected swab and Self-swab collection | Secondary Endpoint 3.1: Feasibility and acceptability of CAD CXR-AI and NPOC tongue swab and sputum swab from diverse perspectives including people seeking care, and health system, and policy makers
| Within 6 Months of data collection |
| Exploratory objective Self-Swab Sub-study Exploratory Objective 3: Comparison between Provider-collected swab and Self-swab collection | Exploratory Endpoint 3.2: Diagnostic accuracy of self-collected tongue swabs
| Within 6 months of data collection |
| Exploratory objective Self-Swab Sub-study Exploratory Objective 3: Comparison between Provider-collected swab and Self-swab collection | Exploratory Endpoint 3.3: Diagnostic accuracy of HCW-collected tongue swabs
| Within 6 months of data collection |
| Exploratory objective Sequential Tongue Swab Collection Sub-study Exploratory Objective 4: To evaluate the diagnostic yield and incremental value of sequentially collected tongue swabs for TB diagnosis using an NPOC test device | Exploratory Endpoint 4.1: Diagnostic yield of TB by swab order (1 through 4)
| Within 6 months of data collection |
| Exploratory objective Sequential Tongue Swab Collection Sub-study Exploratory Objective 4: To evaluate the diagnostic yield and incremental value of sequentially collected tongue swabs for TB diagnosis using an NPOC test | Exploratory Endpoint 4.2: Diagnostic accuracy using first swab only, 1-2 combined, 1-3 combined, 1-4 combined
| Within 6 months of data collection |
| Exploratory objective Sequential Tongue Swab Collection Sub-study Exploratory Objective 4: To evaluate the diagnostic yield and incremental value of sequentially collected tongue swabs for TB diagnosis using an NPOC test device | Exploratory Endpoint 4.3: Incremental diagnostic yield by swab order (additional positives with each subsequent swab)
| Within 6 months of data collection |
| Objective 5 Exploratory objective Lung Flute ECO sub study To evaluate the diagnostic yield of tuberculosis and sputum production using the Lung Flute ECO device compared with standard sputum collection without the device | Exploratory Endpoint 5.1: Incremental diagnostic yield of TB compared with sputum collection without the Lung Flute ECO device
| within 6 months of data collection |
| Objective 5 Exploratory objective Lung Flute ECO sub study To evaluate the diagnostic yield of tuberculosis and sputum production using the Lung Flute ECO device compared with standard sputum collection without the devic | Exploratory Endpoint 5.2 : Incremental yield of participants able to produce sputum greater than 1 mL compared with sputum collection without the Lung Flute ECO device
Comparison of proportions producing sputum volume greater than 1 mL with versus without the Lung Flute ECO device | Within 6 months of data collection |
| Exploratory Objective 6: To estimate downstream health economic outcomes such as disability-adjusted life years (DALYs) | Secondary Endpoint 6.1: Incremental cost per DALY averted (by diagnostic algorithm)
| within 6 months of data collection |
| Background |
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| 28727491 | Background | Lessells RJ, Cooke GS, McGrath N, Nicol MP, Newell ML, Godfrey-Faussett P. Impact of Point-of-Care Xpert MTB/RIF on Tuberculosis Treatment Initiation. A Cluster-randomized Trial. Am J Respir Crit Care Med. 2017 Oct 1;196(7):901-910. doi: 10.1164/rccm.201702-0278OC. |
| 32936877 | Background | Frascella B, Richards AS, Sossen B, Emery JC, Odone A, Law I, Onozaki I, Esmail H, Houben RMGJ. Subclinical Tuberculosis Disease-A Review and Analysis of Prevalence Surveys to Inform Definitions, Burden, Associations, and Screening Methodology. Clin Infect Dis. 2021 Aug 2;73(3):e830-e841. doi: 10.1093/cid/ciaa1402. |
| 38490237 | Background | Stuck L, Klinkenberg E, Abdelgadir Ali N, Basheir Abukaraig EA, Adusi-Poku Y, Alebachew Wagaw Z, Fatima R, Kapata N, Kapata-Chanda P, Kirenga B, Maama-Maime LB, Mfinanga SG, Moyo S, Mvusi L, Nandjebo N, Nguyen HV, Nguyen HB, Obasanya J, Adedapo Olufemi B, Patrobas Dashi P, Raleting Letsie TJ, Ruswa N, Rutebemberwa E, Senkoro M, Sivanna T, Yuda HC, Law I, Onozaki I, Tiemersma E, Cobelens F; scTB Meta Investigator Group. Prevalence of subclinical pulmonary tuberculosis in adults in community settings: an individual participant data meta-analysis. Lancet Infect Dis. 2024 Jul;24(7):726-736. doi: 10.1016/S1473-3099(24)00011-2. Epub 2024 Mar 12. |
| 40127658 | Background | Dheda K, Perumal T, Fox GJ. Asymptomatic tuberculosis: undetected and underestimated, but not unimportant. Lancet. 2025 May 24;405(10492):1797-1800. doi: 10.1016/S0140-6736(25)00555-0. Epub 2025 Mar 22. No abstract available. |
| 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/ |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003936 | Diagnosis, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D003933 | Diagnosis |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided