Start Taking Action For TB Diagnosis
START4ALL
1 other identifier
observational
14,747
7 countries
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
February 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2025
CompletedNovember 21, 2025
November 1, 2025
Same day
April 5, 2023
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of performance of selected TB test
Generation of robust estimates of the diagnostic accuracy and performance of TB tests and TB test combinations in primary healthcare settings and key and vulnerable populations (KVPs).
18 months
Secondary Outcomes (2)
Secondary study endpoint (2)
18 months
Secondary study endpoint (1)
18 months
Study Arms (18)
Cameroon PHC clinics adults
Recruitment of adults in PHC clinic in Cameroon. Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1000. Recruitment type: PCF, ICF.
Cameroon children
Recruitment of children in Cameroon. Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 500. Recruitment type: PCF, ICF.
Cameroom informal settlement/people living rurally
Recruitment of adults using ACF in informal settlements/people living rurally.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 814.
Nigeria PHC clinics
Recruitment of adults in PHC clinics in Nigeria. Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1000. Recruitment type: PCF, ICF.
Nigeria District Hospitals
Recruitment of adults in District Hospitals in Nigeria. Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 700. Recruitment type: PCF, ICF.
Cameroon District Hospitals
Recruitment of adults in District Hospitals in Cameroon.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1003. Recruitment type: PCF, ICF.
Nigeria nomads, internaly displaced individuals and refugees
Recruitment of adults using active case finding, including nomads, IPD and refugees in Nigeria.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 2004.
Kenya PHC clinics
Recruitment of adults in PHC clinics in Kenya.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 700. Recruitment type: PCF, ICF.
Kenya Distric Hospitals
Recruitment of adults in District Hospitals in Kenya.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 700. Recruitment type: PCF, ICF.
Bangladesh District Hospitals
Recruitment of adults in District Hospitals in Bangladesh.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1000. Recruitment type: PCF, ICF.
Bangladesh informal settlements
Recruitment of adults in informal settlements using active case finding in Bangladesh.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1000.
Brazil PHC clinics
Recruitment of adults in PHC clinics in Brazil. One is located in Aracaju and the other in Maceio. Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1000. Recruitment type: PCF, ICF.
Viet Nam children
Recruitment of children in Viet Nam.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 500. Recruitment type: PCF, ICF, ACF.
Viet Nam District Hospital adults
Recruitment of adults in a District Hospitals in Viet Nam. Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1000. Recruitment type: PCF, ICF.
Viet Nam informal settlements
Recruitment of adults using active case finding in informal settlements in Viet Nam.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1500.
Malawi PHC clinics
Recruitment of adults in PHC clinics in Malawi.Tests to be implemented: CAD X-rays, POC qualitative CRP, POC quantitative CRP, LAM (for general population), Xpert® Ultra pooling (2-4 samples). Estimated sample size: 1200. Recruitment type: PCF, ICF.
Key Informant Interviews (KII)
Virtual and in-person interviews on stakeholders' opinions on the barriers and facilitators to access, delivery, and scale-up of TB test combinations at the individual, community, health system, policy, commercial, and political levels. We will interview international leaders in the field of TB diagnostic tool design, development, procurement, and delivery. Estimated sample size: ≥ 4 in each country and 5-10 international stakeholders. Given limited time and stakeholder availability, we may decide to combine KIIs with more than one international stakeholder participant. This will be done in the 7 countries (Bangladesh, Brazil, Cameroon, Nigeria, Malawi, Kenya and Vietnam)
Focus group discussions (FGDs) and/or participatory workshops
FGDs and/or participatory workshops will include (but are not limited to) people with TB disease, TB survivors, civil society leaders, and community representatives. The proposed topic guide will explore perceptions of participants concerning potential barriers/challenges and facilitators/enablers to the implementation of existing and new TB tests and test combinations across individual, health system, and community levels, but with a focus on the individual level. Estimated sample size: 1-2 (6-8 participants each) in each country. This will be done in the 7 countries (Bangaldesh, Brazil, Cameroon, Nigeria, Malawi, Kenya and Vietnam).
Interventions
CRP increases after 6 hours in acute inflammatory processes associated with bacterial infections, post operative conditions or tissue damage. Measurement of Values \>10 mg/L are defined as abnormal (In Viet Nam, measurement of values \>5mg/L). In Bangladesh, Brazil, Cameroon and Viet Nam, the quantitative POC device used will be ichroma™ CRP (Boditech Med Inc.'s Technical Services, Gang-won-do, Korea). In Kenya and Malawi, the quantitative POC test kit to be used is the hs-CRP+CRP Fast Test Kit, on the Getein 1160 Immunofluorescence Quantitative Analyzer (Getein Biotech, Inc., Nanjing, China).
CRP qualitative (POC) rapid tests are immunochromatographic based assays for qualitative or semiquantitative determination of CRP circulating in blood, serum or plasma at the Point of Care with a time to result in 5 minutes. Three commercial tests will be considered in the study depending on in-country procurement: Actim® CRP (Medix Biochemica Group, Espoo, Finland), Nadal® CRP test (nal von minden GmbH, Moers, Germany) and PRIMA® home test (Prima Lab SA, Balerna, Switzerland). The principle is the same for the three tests, CRP levels are detected through monoclonal antibodies raised against CRP. Antibodies are labelled with gold particles for visualization.
FujiLAM is a urine-based assay, Fujifilm SILVAMP TB LAM (FujiLAM; Fujifilm, Tokyo, Japan), which was developed to detect lipoarabinomannan on an instrument-free platform. Results are available in less than 1 hour. The assay combines a pair of high affinity monoclonal antibodies directed towards largely Mycobacterium tuberculosis-specific lipoarabinomannan epitopes and a silver-amplification step that increases the visibility of test and control lines. This enables the detection of urinary lipoarabinomannan concentrations that are approximately 30 times lower than that detected by a previous test called AlereLAM (Alere Determine™ TB LAM) and exhibits improved analytical specificity compared with AlereLAM.
The Xpert® MTB/RIF Ultra Assay (Xpert® Ultra) (Cepheid®, California, USA), is a semi-quantitative, nested real-time polymerase chain reaction (PCR) diagnostic test for the detection of Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples or concentrated sediments prepared from induced or expectorated sputum. GeneXpert® IV platform will be used to do the pooling in ACF and at the POC in PHC. For ACF and health services with limited infrastructure, the platform will be powered with portable batteries. The platform will be used with 2 modules with the option to add two more modules in Phase 2 of the study to allow the testing of more specimens.
Examples: FujiFilm Xair™ FujiFilm Xair™ (Fujifilm, Tokyo, Japan) is a mobile X-ray machine that facilitates successful diagnoses in various medical settings, serving patients with limited mobility or people living in inaccessible geographies. The image is produced in the X-ray cassette and automatically transmitted to the laptop for visualization and interpretation by the physician. MinXRay MinXray's Impact is an FDA certified, complete battery operated, portable radiography system that can perform a complete range of radiographic procedures with excellent visualization of all body parts. The Impact system was designed and developed for operation in austere environments where the absence of climate controls and difficult terrain may limit access to the region. The rugged design of the system itself and the custom packaging provide exceptional durability during operation and transportation. Operates completely wirelessly.
Qure.ai (Qure.ai, New York, USA) is a computer-aided detection (CAD) software for automated screening of TB. Qure.ai is a mobile-based interpretation software that screens chest X-ray to detect TB in less than a minute. Qure.ai can distinguish abnormal scans from normal and detect abnormalities in the lungs, pleura, mediastinum, bones, diaphragm, and heart. Once the X-ray has been interpreted by Qure.ai, the chest X-ray film image is uploaded from the mobile phone through the qTrack application software automatically. The qTrack is an end-to-end disease management platform that enables access and connectivity to all patient information between administrative platforms, managers, healthcare professionals, laboratory technicians and relevant stakeholders. The use of Qure.ai facilitates the interpretation of chest X-rays on time where there are no qualified clinicians available, preventing delays in TB diagnosis.
Sputum samples will be processed on the GeneXpert® Model GX-IV with 2 modules if the pooling is performed at the same place as the sample collection (POC testing, ACF) or on the GeneXpert® platform available at the reference laboratory. For pooled testing, an equal volume of each of the remaining processed samples (samples already processed to be tested individually) will be pooled together. We aim for pools of 4 samples. If the number of sputum samples received in a day \<4 , those processed samples may be kept in the fridge, and pooled testing resumed the following day if more samples are received. If on the following day, not enough samples are received, pools of 2 or 3 samples will be made. Processed samples cannot be tested after 24 hours. If there is no fridge on-site, or on the last day of the week, all samples will be pooled at the end of the day. Pools of four will be prioritized, but if there are less than four samples, those will be pooled (pools of 2 or 3 samples).
The KIIs and FGDs will be semi-structured and the lead Research Assistant will follow a topic guide with open questions plus probes that provides a framework concerning the topics and issues of interest. KIIs will cover topics around TB tests and test combinations. The in-country KIIs and FGDs will be conducted in the local language, audio recorded, transcribed, translated into English. International KII participants will have their KII conducted with a Co-Investigator and Research Assistant from the Start4All team virtually on a suitable platform, which may include MS Teams or Zoom. The workshops will include interactive presentations and small, interdisciplinary working groups to review the realist evaluation (RE) findings and initial RE-derived program theory, and in-country barriers and enablers. Workshop outputs will be synthesized in an open-access report and shared with participants and selected decision makers and policy-making organizations.
Eligibility Criteria
Individuals suspected of having TB.
You may qualify if:
- 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
- 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
- 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
- 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
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Icddr,B
Dhaka, Bangladesh
Fundação de Apoio à Pesquisa e Extensão de Sergipe
Sergipe, Brazil
CHPR
Bamenda, Cameroon
KEMRI
Kisumu, Kenya
Malawi-Liverpool-Wellcome Clinical
Blantyre, Malawi
Zankli Research Centre, Bingham University
Abuja, Nigeria
Janna Health Foundation
Adamawa, Nigeria
Friends for International TB Relief
Hà Nội, Vietnam
Biospecimen
Sputum, urine and blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2023
First Posted
May 6, 2023
Study Start
February 28, 2025
Primary Completion
February 28, 2025
Study Completion
March 28, 2025
Last Updated
November 21, 2025
Record last verified: 2025-11