Start4All SCREEN-TB PROTOCOL

Starting soon · Not applicable

Conditions studied: TB - Tuberculosis

In brief

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

Key facts

Study ID

NCT07517471

Run by

Liverpool School of Tropical Medicine

People needed

37000

Starts

2026-04-01

Expected to finish

2027-05-01

Last updated by the study team

2026-04-08

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: accepted.

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
• o All individuals presenting to the facility, regardless of symptoms or ability to produce sputum, will be eligible for inclusion.
• 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.

Full record on ClinicalTrials.gov

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