TB-CAPT CORE Truenat Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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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

Conditions
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Tuberculosis, Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Truenat TB platform/TB assays


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TB testing using the Truenat platform/TB assays<br>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 | Diagnostic Test: Truenat TB platform/TB assays<br>* 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.<br>|
| No Intervention: Standard of care Arm<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. 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 | 60 days |