TB-CAPT CORE Truenat Trial
Molbio Truenat TB Platform Combined With the Truenat TB Assays for Detection of Tuberculosis and Rifampicin Resistance in Adults With Presumptive Pulmonary Tuberculosis at Primary-level Diagnostic Centres in Tanzania and Mozambique: a Pragmatic, Cluster-randomized Controlled Trial
1 other identifier
interventional
3,987
2 countries
4
Brief Summary
A cluster randomized controlled trial to evaluate the effect of placing Truenat platform/TB assays at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Typical duration for not_applicable
4 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
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedStudy Start
First participant enrolled
August 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 4, 2025
April 1, 2025
1.8 years
September 23, 2020
April 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
7 days
Secondary Outcomes (4)
Time to bacteriological confirmation of TB
60 days
Proportion of patients treated for TB up to 60 days from enrolment
60 days
Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
60 days
Cost and productivity related endpoints
60 days
Study Arms (2)
TB testing using the Truenat platform/TB assays
EXPERIMENTALTB testing using the Truenat platform/TB assays placed at primary health care clinics combined with rapid communication of results and same day TB treatment initiation
Standard of care Arm
NO INTERVENTIONStandard of care for TB testing using a combination of smear microscopy and laboratory (off-site) Xpert testing, may vary by clinic depending on availability of transport and stock of Xpert MTB/RIF or Xpert MTB/RIF Ultra cartridges (Xpert).
Interventions
Truenat TB platform/TB assays, a molecular diagnostic test developed by Molbio diagnostics, for the diagnosis of Mycobacterium tuberculosis complex (MTBC) and Truenat MTB-RIF Dx for detection of RIF resistance was endorsed in 2020 by the WHO for TB diagnosis. The system has been designed to be operated as a point-of-care- diagnostic solution in peripheral laboratories with minimal infrastructure. It takes about 25 minutes to do the DNA extraction and another 35 minutes to diagnose TB. It is portable and battery operated, have no need for a computer or laptop, and operate from 2-40 C ambient temperature. The system uses room temperature stable reagents with long shelf life.
Eligibility Criteria
You may qualify if:
- Patients with presumptive pulmonary TB, as defined by the national TB treatment guidelines in each country: patients with cough more than 1-2 weeks and/or fever, night sweats, blood-stained sputum (haemoptysis) significant weight loss, abnormalities on chest radiograph
- Adults 18 years old and above who are able and willing to consent
You may not qualify if:
- Circumstances that raise doubt on free, informed consent (e.g. in a mentally impaired person or a prisoner)
- Already diagnosed with TB
- Currently receiving anti-TB therapy
- Patients with symptoms which are only attributable to extra-pulmonary TB
- Patients who are seriously ill and need to be admitted to hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Foundation for Innovative New Diagnostics, Switzerlandlead
- Ludwig-Maximilians - University of Munichcollaborator
- National Institute for Medical Research, Tanzaniacollaborator
- Centro de Investigação em Saúde de Manhiçacollaborator
- Instituto Nacional de Saúde, Mozambiquecollaborator
- Ifakara Health Institutecollaborator
Study Sites (4)
Centro de Investigação em Saúde de Manhiça-Fundação
Manhiça, Vila Da Manhiça, 1929, Mozambique
Instituto Nacional de Saúde (INS)
Maputo, 1100, Mozambique
Ifakara Health Institute
Dar es Salaam, Box 78 373, Tanzania
National Institute of Medical Research (NIMR)
Mbeya, 2410, Tanzania
Related Publications (2)
Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.
PMID: 40122135DERIVEDLeukes VN, Hella J, Sabi I, Cossa M, Khosa C, Erkosar B, Mangu C, Siyame E, Mtafya B, Lwilla A, Viegas S, Madeira C, Machiana A, Ribeiro J, Garcia-Basteiro AL, Riess F, Elisio D, Sasamalo M, Mhalu G, Denkinger CM, Castro MDM, Bashir S, Schumacher SG, Tagliani E, Malhotra A, Dowdy D, Schacht C, Buech J, Nguenha D, Ntinginya N, Ruhwald M, Penn-Nicholson A, Kranzer K; TB-CAPT Consortium. Study protocol: a pragmatic, cluster-randomized controlled trial to evaluate the effect of implementation of the Truenat platform/MTB assays at primary health care clinics in Mozambique and Tanzania (TB-CAPT CORE). BMC Infect Dis. 2024 Jan 19;24(1):107. doi: 10.1186/s12879-023-08876-8.
PMID: 38243223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katharina Kranzer
Medical Center of the University of Munich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The objective of the trial is to assess Truenat platform/TB assays in clinical care. The use of Truenat platform/TB assays does not allow blinding of clinicians and participants in this trial. The trial-related procedures will be embedded into the routine practice at the primary-level facility. Data analysts will be blinded to intervention allocation. Randomisation takes place on a cluster level rather than for the individual patients to avoid contamination between the arms within a health facility. Since clinics will be relatively far apart, contamination is unlikely.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2020
First Posted
September 29, 2020
Study Start
August 28, 2022
Primary Completion
June 16, 2024
Study Completion
December 31, 2024
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Upon publication of the main study manuscript
Individual, de-identified participant data may be shared, including data dictionaries. Available documents include the study protocol and statistical analysis plan. Templates of the informed consent forms may be shared upon request. The data will be available immediately following publication with no end date, will be shared with anyone who wishes to access them, and will be available for any purpose of analyses.