NCT04568954Completed
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
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3987 (actual)
- First submitted
- 23 Sept 2020
- Start date
- 28 Aug 2022
- Primary completion date
- 16 Jun 2024
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Diseases
- Tuberculosis
- NCT number
- NCT04568954
What you commit to
- Study type: Interventional
- Participants enrolled: 3987
- From 28 Aug 2022 to the primary completion date, 16 Jun 2024
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving anti-TB therapy
Other
- Circumstances that raise doubt on free, informed consent (e.g. in a mentally impaired person or a prisoner)
- Already diagnosed with TB
- Patients with symptoms which are only attributable to extra-pulmonary TB
- Patients who are seriously ill and need to be admitted to hospital
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigação em Saúde de Manhiça-Fundação Coordinator of this site? Confirm its status | Manhiça | Mozambique | Unknown status |
| Instituto Nacional de Saúde (INS) Coordinator of this site? Confirm its status | Maputo | Mozambique | Unknown status |
| Ifakara Health Institute Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Unknown status |
| National Institute of Medical Research (NIMR) Coordinator of this site? Confirm its status | Mbeya | Tanzania | Unknown status |
Related publications
- User perspectives on the Molbio Truenat platform and tuberculosis assays for decentralised testing in Mozambique and Tanzania.BMJ Glob Health · 2026 · PMID 42114928
This page is information, not medical advice. Discuss any trial with your doctor.