NCT07517471Not yet recruiting
Start4All SCREEN-TB PROTOCOL
Start4All - Start Taking Action for TB Diagnosis SCREEN-TB
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 37000 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- Apr 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Liverpool School of Tropical Medicine
- Diseases
- Tuberculosis
- NCT number
- NCT07517471
What you commit to
- Study type: Interventional
- Planned participants: 37000
- From Apr 2026 to the primary completion date, Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Duplicate enrolment o Previous enrolment in SCREEN-TB.
Other illness
- 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
Age
- Age
- o Below 10 years at enrolment
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 10 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.