Start4All SCREEN-TB PROTOCOL

NCT07517471 | Not Yet Recruiting DMC

• 1 other identifier: 125
• Study Type: interventional
• Target: 37,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

TB - Tuberculosis

Keywords

TB; Diagnostics

Outcome Measures

Primary Outcomes (2)

• 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 * WHO: All participants enrolled in the study (≥10 years) * WHAT: Number and proportion (out of attempted TB testing) of participants diagnosed with TB (microbiologically confirmed and clinically diagnosed) per diagnostic algorithm pathway * WHEN: Primary = at completion of diagnostic work-up (Day 1-3); Secondary = confirmed via NTP registry data at treatment initiation * WHERE: Study healthcare facilities and referral laboratories in Bangladesh, Cameroon, Kenya, Nigeria, Viet Nam * WHY: To determine incremental case detection across different screening approaches * HOW MEASURED: 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. * WHO: All participants with interpretable test results * WHAT: Sensitivity, specificity, PPV, NPV of CAD CXR-AI and NPOC tongue swab and sputum swab as initial screening tools * WHEN: Calculated after completion of reference standard testing for all participants * WHERE: Central data analysis * WHY: To compare performance characteristics of screening tools * HOW MEASURED: * Reference standard = LC-NAAT; * Using standard diagnostic accuracy definitions and reporting all estimates together with 95% confidence intervals; * Receiver operating characteristic (ROC) curves for CAD CXR-AI thresholds * Pre-specified handling of indeterminate/uninterpretable results

  Completed within 6 month of data collection

Secondary Outcomes (8)

• 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

  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

  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

  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

  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

  Completed within 6 month of data collection

Other Outcomes (18)

• 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

  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

  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

  Completed within 6 month of data collection

Study Arms (1)

Diagnostic

OTHER

Diagnostic

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: Portable Chest X-ray Image Acquisition; Diagnostic Test: Computer-Aided Detection (CAD) Chest X-ray (CXR-AI); Other: Screen TB&HIV sub-study diagnostic test

Interventions

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.

Diagnostic

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.

Diagnostic

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

Diagnostic

Near point of care (NPOC) NAATs DIAGNOSTIC_TEST

* Near point of care instrument that can test tongue swabs and sputum swabs. * 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 use and move around and only takes 15 to 35 minutes to conclude the result.

Diagnostic

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

Diagnostic

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.

Diagnostic

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Adults aged 15 years and above or
• Adolescents aged 10-14 years
• Facility setting
• o Participating healthcare facilities (e.g., primary health centres, district hospitals), including both rural and urban facilities.
• Screening eligibility
• Consent
• Written informed consent (and assent for adolescents (10-14 years) and adults (≥15 - 17 years) if included) must be obtained according to local ethics and regulatory requirements.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead

Related Publications (30)

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MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Diagnosis, Computer-Assisted; Diagnostic Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnosis; Diagnostic Techniques and Procedures

Study Officials

• Tom Wingfield, PhD FRCP DTMH DipHIV

  Liverpool School of Tropical Medicine

  STUDY DIRECTOR

• Vibol Lem, PhD

  Liverpool School of Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Lucy Read, BA

CONTACT

+44 (0)151 705 3715; start4all@lstmed.ac.uk

Vibol Lem, PhD

CONTACT

vibol.lem@lstmed.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be available for a maximum of 5 years after study close
• Access Criteria: All requests for access to the IPD will be assessed by the Sponsor and must be agreed by all Data Controller organisations.