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TuberculosisNCT04568954

TB-CAPT CORE Truenat Trial

A study testing Truenat TB platform/TB assays in people with Tuberculosis and Diagnoses Disease, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis, Diagnoses Disease
What is being tested?
Truenat TB platform/TB assays
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,987 participants
Where
4 sitesin 2 countries
Study dates
28 Aug 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Mozambique2 sites

  • Centro de Investigação em Saúde de Manhiça-Fundação

    Manhiça, Vila Da Manhiça, 1929

  • Instituto Nacional de Saúde (INS)

    Maputo, 1100

Other trials in Mozambique

Tanzania2 sites

  • Ifakara Health Institute

    Dar es Salaam, Box 78 373

  • National Institute of Medical Research (NIMR)

    Mbeya, 2410

Other trials in Tanzania

About this study

Official title: 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

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.

Read the detailed description

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.

In a setup period (survey of study centers) before randomization, the healthcare facilities (=clinics) of 4 sites will be asked to provide information about the number of TB notifications per quarter covering the period 1/2018-6/2020. From this information the foreseeable number of examined patients ("size of a clinic") will be derived, which will be used as a strata variable in randomization process.

Facilities will be randomly allocated to the standard of care (control), or Truenat platform/TB assays (intervention).

A cluster refers to a clinic. The clusters will be assigned to intervention or control arm to one of two diagnostic procedures (SOC [smear microscopy and/or Xpert MTB/RIF Ultra off-site] vs Truenat platform/TB assays on-site) following a restricted randomization strategy, whereby 6 to 8 strata of clusters will be established using the stratification variables site (clinics belong to a site) and size and apply balance criteria for them. The number of strata per site depends on heterogeneity of the sizes of the clinics as established in setup period and may be increased, typically 1 or 2 strata per site will be established.

The primary endpoint will be compared in an individual level analysis with strata and intervention as fixed effects and cluster as random effect.

Being tested
Truenat TB platform/TB assays
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Truenat TB platform/TB assaysDiagnostic test

    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.

Study groups in NCT04568954
Study groupRoleWhat they receive
TB testing using the Truenat platform/TB assaysExperimentalTB 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
Receives: Diagnostic Test: Truenat TB platform/TB assays
Standard of care ArmNo 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days

Secondary outcomes (4)

  1. Time to bacteriological confirmation of TB

    Time to bacteriological confirmation of TB (up to 180 days) from enrolment

    Measured: 60 days

  2. Proportion of patients treated for TB up to 60 days from enrolment

    Proportion of patients treated for TB up to 60 days from enrolment

    Measured: 60 days

  3. Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment

    Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment

    Measured: 60 days

  4. Cost and productivity related endpoints

    Patients' costs related to care at 60 days from enrolment.

    • Number of lost working days over the past month at 60 days from enrolment
    • Monthly earning in the past month at 60 days from enrolment

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2020
  2. Study start28 Aug 2022
  3. Primary completion16 Jun 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,987 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568954
Sponsor's protocol ID
TB041-3/1
Status last verified
Apr 2025
First submitted
23 Sep 2020
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Castro MDM, Khosa C, Mhalu G, Ndelwa L, Mwanyonga S, Zumba T, Elisio D, Magul K, Manganhe Y, Machiana A, Cossa M, Edom R, Hella J, Nguenha D, Ruhwald M, Leukes V, Penn-Nicholson A, Kranzer K, Denkinger CM; TB-CAPT Consortium. User perspectives on the Molbio Truenat platform and tuberculosis assays for decentralised testing in Mozambique and Tanzania. BMJ Glob Health. 2026 May 11;11(5):e019902. doi: 10.1136/bmjgh-2025-019902.

    PubMed 42114928

  • 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.

    PubMed 40122135

  • Leukes 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.

    PubMed 38243223

Questions about this trial

What is this clinical trial studying?

A study testing Truenat TB platform/TB assays in people with Tuberculosis and Diagnoses Disease, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mozambique, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04568954, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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