Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar
NCT ID: NCT05406453
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98362 participants
INTERVENTIONAL
2022-05-16
2024-06-30
Brief Summary
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It is hypothesized that prospective WGS-guided epidemiological investigations improve case detection compared to current best practices by adapting contact tracing strategies to local transmission patterns.
A cluster randomized controlled trial (cRCT) will be performed in high TB incidence villages of Haute Matsiatra region in Madagascar. Communities will be randomized in three separate TB control strategies comparing (1) standard of care, (2) the World Health Organization (WHO) recommended best practices and (3) a novel intervention involving TB WGS cluster-guided epidemiological investigations. The incremental value of TB WGS on case notifications and reduction of TB burden will be measured.
Secondary studies will be nested within this cRCT will include:
* A qualitative study which will increase the understanding of the factors facilitating and hindering implementation of WGS-based diagnostics within health systems.
* A cost effectiveness analysis study which will measure the cost effectiveness of newly implemented laboratory methods.
Field and genomic epidemiology data from this project will inform future work on the design of community-level TB elimination strategies in collaboration with Madagascar National TB program
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
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Madagascar standard of care
Description :
* Passive case finding,
* Smear microscopy testing, and
* household contact tracing
No interventions assigned to this group
Best practices
Description :
* Active case finding,
* Smear microscopy
* Xpert MTB/RIF Ultra testing (= rapid test by Genexpert for tuberculosis (TB) and rifampin resistance (RIF-R)) and
* household contact tracing
No interventions assigned to this group
Novel intervention
Description :
* Active case finding,
* Smear microscopy
* Xpert MTB/RIF Ultra testing and
* household contact tracing
Whole Genome Sequencing testing
Whole Genome Sequencing testing, community-based contact tracing
Interventions
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Whole Genome Sequencing testing
Whole Genome Sequencing testing, community-based contact tracing
Eligibility Criteria
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Inclusion Criteria
* subject living in the study area
Exclusion Criteria
ALL
No
Sponsors
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The National Tuberculosis Program, Madagascar
UNKNOWN
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
OTHER
Institut Pasteur de Madagascar
OTHER
Responsible Party
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Simon Grandjean Lapierre
Researcher
Principal Investigators
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Simon Grandjean Lapierre, MD MSc FRCPC
Role: PRINCIPAL_INVESTIGATOR
CHUM
Locations
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Fokontany Vohibato
Vohibato, , Madagascar
Countries
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References
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Ametepe ESA, Andriamanoha N, Andrianomanana FR, Point F, Mangahasimbola RT, Dyachenko A, Hall M, Gamana TM, Knoblauch AM, Razafindrasoa YY, Nimalan A, Behr M, Durand M, Johri M, Iqbal Z, Rakotoarivelo AR, Randremanana RV, Rakotosamimanana N, Lapierre SG. Whole genome sequencing of M. tuberculosis for disease control in high-burden settings: study protocol for a cluster randomized controlled trial evaluating different community-wide intervention strategies in rural Madagascar. Trials. 2024 Oct 25;25(1):717. doi: 10.1186/s13063-024-08537-4.
Other Identifiers
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PJT 75243
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022-01
Identifier Type: -
Identifier Source: org_study_id
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