NCT05406453

Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar

Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - a Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98,362 (actual)
• Sponsor: Institut Pasteur de Madagascar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Tuberculosis (TB) whole genome sequencing (WGS) allows outbreak identification and disease transmission tracking. 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

Conditions

• Tuberculosis

Interventions

Type	Name	Description
OTHER	Whole Genome Sequencing testing	Whole Genome Sequencing testing, community-based contact tracing

Timeline

• Start date: 2022-05-16
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-06-06
• Last updated: 2024-10-16

Locations

1 site across 1 country: Madagascar