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).
Clinical trial
Diagnostics
Efficacy
Implementation
Truenat
Tuberculosis
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
19 Jan 2024
19 Jan 2024
Historique:
received:
12
09
2023
accepted:
05
12
2023
medline:
20
1
2024
pubmed:
20
1
2024
entrez:
19
1
2024
Statut:
epublish
Résumé
In 2020, the WHO-approved Molbio Truenat platform and MTB assays to detect Mycobacterium tuberculosis complex (MTB) and resistance to rifampicin directly on sputum specimens. This primary health care center-based trial in Mozambique and Tanzania investigates the effect of Truenat platform/MTB assays (intervention arm) combined with rapid communication of results compared to standard of care on TB diagnosis and treatment initiation for microbiologically confirmed TB at 7 days from enrolment. The Tuberculosis Close the Gap, Increase Access, and Provide Adequate Therapy (TB-CAPT) CORE trial employs a pragmatic cluster randomized controlled design to evaluate the impact of a streamlined strategy for delivery of Truenat platform/MTB assays testing at primary health centers. Twenty-nine centers equipped with TB microscopy units were selected to participate in the trial. Among them, fifteen health centers were randomized to the intervention arm (which involves onsite molecular testing using Truenat platform/MTB assays, process process optimization to enable same-day TB diagnosis and treatment initiation, and feedback on Molbio platform performance) or the control arm (which follows routine care, including on-site sputum smear microscopy and the referral of sputum samples to off-site Xpert testing sites). The primary outcome of the study is the absolute number and proportion of participants with TB microbiological confirmation starting TB treatment within 7 days of their first visit. Secondary outcomes include time to bacteriological confirmation, health outcomes up to 60 days from first visit, as well as user preferences, direct cost, and productivity analyses. TB-CAPT CORE trial has been approved by regulatory and ethical committees in Mozambique and Tanzania, as well as by each partner organization. Consent is informed and voluntary, and confidentiality of participants is maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals. US National Institutes of Health's ClinicalTrials.gov, NCT04568954. Registered 23 September 2020.
Sections du résumé
BACKGROUND
BACKGROUND
In 2020, the WHO-approved Molbio Truenat platform and MTB assays to detect Mycobacterium tuberculosis complex (MTB) and resistance to rifampicin directly on sputum specimens. This primary health care center-based trial in Mozambique and Tanzania investigates the effect of Truenat platform/MTB assays (intervention arm) combined with rapid communication of results compared to standard of care on TB diagnosis and treatment initiation for microbiologically confirmed TB at 7 days from enrolment.
METHODS
METHODS
The Tuberculosis Close the Gap, Increase Access, and Provide Adequate Therapy (TB-CAPT) CORE trial employs a pragmatic cluster randomized controlled design to evaluate the impact of a streamlined strategy for delivery of Truenat platform/MTB assays testing at primary health centers. Twenty-nine centers equipped with TB microscopy units were selected to participate in the trial. Among them, fifteen health centers were randomized to the intervention arm (which involves onsite molecular testing using Truenat platform/MTB assays, process process optimization to enable same-day TB diagnosis and treatment initiation, and feedback on Molbio platform performance) or the control arm (which follows routine care, including on-site sputum smear microscopy and the referral of sputum samples to off-site Xpert testing sites). The primary outcome of the study is the absolute number and proportion of participants with TB microbiological confirmation starting TB treatment within 7 days of their first visit. Secondary outcomes include time to bacteriological confirmation, health outcomes up to 60 days from first visit, as well as user preferences, direct cost, and productivity analyses.
ETHICS AND DISSEMINATION
BACKGROUND
TB-CAPT CORE trial has been approved by regulatory and ethical committees in Mozambique and Tanzania, as well as by each partner organization. Consent is informed and voluntary, and confidentiality of participants is maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals.
TRIAL REGISTRATION
BACKGROUND
US National Institutes of Health's ClinicalTrials.gov, NCT04568954. Registered 23 September 2020.
Identifiants
pubmed: 38243223
doi: 10.1186/s12879-023-08876-8
pii: 10.1186/s12879-023-08876-8
doi:
Banques de données
ClinicalTrials.gov
['NCT04568954']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
107Subventions
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Organisme : European and Developing Countries Clinical Trials Partnership
ID : RIA2017S-2007
Informations de copyright
© 2024. The Author(s).
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