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Completed

NCT Number: NCT04568954

TB-CAPT CORE Truenat 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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Diagnoses Disease Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigação em Saúde de Manhiça-Fundação, Manhiça, Vila Da Manhiça, Mozambique

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants

    Time frame: 7 days

    Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants

Secondary outcomes

  1. Time to bacteriological confirmation of TB

    Time frame: 60 days

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

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

    Time frame: 60 days

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

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

    Time frame: 60 days

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

  4. Cost and productivity related endpoints

    Time frame: 60 days

    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

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

  • Centro de Investigação em Saúde de Manhiça
  • Ifakara Health Institute
  • Instituto Nacional de Saúde, Mozambique
  • Ludwig-Maximilians - University of Munich
  • National Institute for Medical Research, Tanzania

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2020
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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