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NCT05845112Completed

Start Taking Action For TB Diagnosis

Start Taking Action For TB Diagnosis (START4ALL)

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

Globally, tuberculosis (TB) is one of the main causes of death and the leading cause from a single infectious agent. In 2020, an estimated 9.9 million people developed TB and 1.5 million died. Millions of people remain undiagnosed with TB, hindering efforts to end TB. TB tests have inadequate accuracy or performance characteristics for implementation across all populations and settings. None of the tests meet the WHO-Target-Product Profile for TB screening and most need specialized laboratory staff and infrastructure, making them unsuitable for primary health care (PHC). The overall objectives for this project are to: 1. To evaluate the performance of selected TB tests and test combinations in primary health care settings and KVPs. 2. To identify test combinations that increase the proportion of people diagnosed with microbiologically confirmed TB in comparison to a microbiological reference standard. 3. To demonstrate that test combinations are cost-efficient and feasible for scale-up to facilitate enhanced access to TB diagnosis in locations and for populations where they are not currently available. Methods in brief: Objectives 1 and 2 will use the same methods and will be assessed simultaneously. These objectives will use cross-sectional surveys. Activities will be conducted in Bangladesh, Brazil, Kenya, Cameroon, Malawi, Nigeria, and Viet Nam. Each country will study selected priority populations at risk of TB, including adults attending PHC centers and district hospitals; people living with HIV (PLHIV); marginalized populations (internally displaced, refugees and pastoralists), and children. Activities within countries will use standardized protocols for evaluating diagnostic tests and combinations. Methods for Objective 3 (Phase 1) will be a realist evaluation consisting of a market landscape analysis, evaluation of the costs and cost-efficiency of implementing TB tests and combinations, and a combination of key informant interviews, focus group discussions and/or participatory workshops, depending on appropriateness to stakeholder group and local context, to gather qualitative data on acceptability of TB tests and combinations.

Status (registry)
Completed
Study type
Observational
Enrollment
14747 (actual)
First submitted
5 Apr 2023
Start date
28 Feb 2025
Primary completion date
28 Feb 2025
Lead sponsor
Liverpool School of Tropical Medicine
Diseases
Tuberculosis
NCT number
NCT05845112

What you commit to

  • Study type: Observational
  • Participants enrolled: 14747
  • From 28 Feb 2025 to the primary completion date, 28 Feb 2025
  • 8 sites in 7 countries
  • 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.

Criteria the registry did not label

  • Inclusion criteria for Individuals attending stationary health facilities:
    • health-seeking persons presenting at participating study site health facilities who are:
    • Age 15 years and above
    • PLHIV irrespective of their CD4 count and antiretroviral therapy (ART) status
    • At risk of pulmonary and/or extra-pulmonary TB
    • OR
    • People with a positive WHO-recommended four-symptom screen (W4SS) or parenchymal abnormalities on chest radiography
    • Written informed consent and agreement to follow-up after enrolment (e.g. not planning to relocate)
    • A parent or guardian present at the time of enrolment to provide signed informed consent and assent signed for those aged 15 years to age of majority
    • Exclusion
    • Current anti-TB treatment (counting from the third dose)
    • Any anti-TB treatment within 60 days prior to enrolment
    • Any TB preventive therapy within 6 months prior to enrolment
  • Inclusion criteria for refugees and IDPs
    • health-seeking persons resident in official refugee camps who have cross international borders from other countries; OR
    • internally displaced individuals (IDPs), defined as persons forced or obliged to flee or to leave their homes to avoid the effects of armed conflict, situations of generalized violence, violations of human rights or natural or human-made disasters, and who have not crossed an internationally recognized state border.
    • IDPs can be recruited from refugee camps or among individuals sharing accommodation with local residents.
    • At the time they are presenting at participating study site health facilities.
    • Clinical criteria will be the same as described for individuals attending health facilities
    • Exclusion
    • Same as described for individuals attending health facilities and
    • Individuals who intend to leave the local area in the short term and have no means of contact
  • Inclusion criteria for nomadic populations
    • Participants will be selected using active case finding through community screening camps targeting the nomadic population (nomadic are defined as a member of a group of people who have no fixed home and move according to the seasons from place to place in search of food, water, and grazing land and are usually herders with traditional hierarchies.
    • The dates and locations of screening days will coincide with community market days, after consultation with nomadic community leaders
    • Clinical criteria will be the same as described for individuals attending health facilities
    • Exclusion
    • Same as described for individuals attending health facilities and Individuals who intend to leave the local area in the short term and have no means of contact
  • Inclusion criteria for informal settlements, urban vulnerable groups and the rural poor
    • Participants will be selected using active case finding through community screening activities targeting urban vulnerable groups and the rural poor.
    • Screening will be conducted on dates and in locations agreed with community leaders, depending on the setting.
    • Clinical criteria will be the same as described for individuals attending health facilities.
    • Exclusion
    • Same as described for individuals attending health facilities and Individuals who intend to leave the local area in the short term and have no means of contact.
  • Inclusion criteria for children health-seeking children presenting at participating study site health facilities who:
    • Are between 12 months and 15 years of age.
    • Have presumptive TB based on at least one criterion among the following:
    • Persistent cough for more than 2 weeks
    • Persistent fever for more than 2 weeks
    • Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age \< 2)
    • Failure of broad-spectrum antibiotics for treatment of pneumonia to improve symptoms and signs
    • Suggestive CXR features OR
    • History of contact with a person with TB and any of the symptoms listed above with a shorter duration (\< 2 weeks), if the child is HIV infected or presents with Severe Acute Malnutrition
    • A parent or guardian present at the time of enrolment to provide signed informed consent and assent signed by children \> 7 years old.
    • \> 5 days of anti-TB treatment in the last 3 months or individuals receiving TB preventive therapy
    • Children \<12 months old

Age in the registry: 1 year to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Icddr,B
Coordinator of this site? Confirm its status
DhakaBangladeshUnknown status
Fundação de Apoio à Pesquisa e Extensão de Sergipe
Coordinator of this site? Confirm its status
SergipeBrazilUnknown status
CHPR
Coordinator of this site? Confirm its status
BamendaCameroonUnknown status
KEMRI
Coordinator of this site? Confirm its status
KisumuKenyaUnknown status
Malawi-Liverpool-Wellcome Clinical
Coordinator of this site? Confirm its status
BlantyreMalawiUnknown status
Zankli Research Centre, Bingham University
Coordinator of this site? Confirm its status
AbujaNigeriaUnknown status
Janna Health Foundation
Coordinator of this site? Confirm its status
AdamawaNigeriaUnknown status
Friends for International TB Relief
Coordinator of this site? Confirm its status
Hà NộiVietnamUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.