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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| National Institute for Medical Research, Tanzania | OTHER_GOV |
| Centro de Investigação em Saúde de Manhiça | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TB testing using the Truenat platform/TB assays | Experimental | TB 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 Intervention | Standard 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truenat TB platform/TB assays | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to bacteriological confirmation of TB | Time to bacteriological confirmation of TB (up to 180 days) from enrolment | 60 days |
| Proportion of patients treated for TB up to 60 days from enrolment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharina Kranzer | Medical Center of the University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigação em Saúde de Manhiça-Fundação | Manhiça | Vila Da Manhiça | 1929 | Mozambique | ||
| Instituto Nacional de Saúde (INS) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114928 | Derived | 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. | |
| 40122135 |
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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.
Upon publication of the main study manuscript
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2023 | Oct 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2023 | Oct 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Instituto Nacional de Saúde, Mozambique |
| OTHER_GOV |
| Ifakara Health Institute | OTHER |
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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.
|
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 | 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 | Patients' costs related to care at 60 days from enrolment.
| 60 days |
| Maputo |
| 1100 |
| Mozambique |
| Ifakara Health Institute | Dar es Salaam | Box 78 373 | Tanzania |
| National Institute of Medical Research (NIMR) | Mbeya | 2410 | Tanzania |
| Derived |
| 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. |
| 38243223 | Derived | 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |