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RECRUITING
NCT06702774
NA

Research on Key Interventional Technologies for Controlling the Epidemic in High-prevalence Areas of Tuberculosis in Guangxi, China

Sponsor: University of Toronto

View on ClinicalTrials.gov

Summary

The goal of this study is to find out if using mobile vans with advanced technology can help reduce tuberculosis (TB) in rural Guangxi, China. The study will also examine how practical and cost-effective this approach is. The main questions it aims to answer are: 1) Does this new screening method lower the number of TB cases among high-risk groups? and 2) Is this method practical and acceptable for communities and healthcare workers? Participants in the study will: 1) undergo TB screening with mobile vans that use artificial intelligence (AI) to read chest X-rays, 2) answer a short questionnaire about their symptoms and health history, and 3) provide sputum samples for GeneXpert testing if needed. Some communities will receive the new screening method, while others will continue with usual care. Researchers will compare TB rates in the two groups over three years to see if the new approach works better for TB control. If successful, this method could be used to improve TB control in other areas.

Official title: Active Case Finding Using Mobile Vans Equipped With Artificial Intelligence Aided Radiology Tests and Sputum Collection for Rapid Diagnostic Tests to Reduce Tuberculosis Prevalence Among High-risk Populations in Rural China: a Pragmatic Cluster Randomized Controlled Trial

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72000

Start Date

2021-11-20

Completion Date

2025-04-30

Last Updated

2024-12-06

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Active case finding

Villagers will be informed through public announcements and social workers. Before the campaign, social workers and village doctors will recruit participants and obtain consent through door-to-door visits. A mobile van equipped with an AI-assisted digital radiography (DR) machine and a refrigerator will visit villages on agreed dates. Participants will complete a TB symptom questionnaire and undergo DR screening. Those with TB symptoms or abnormal DR results will provide on-site sputum samples and collect additional morning and night samples. Trained staff will ensure proper collection and offer nebulizer support if needed. Samples will be transported daily to hospitals for testing using smear, culture, and GeneXpert. Participants with negative bacteriological results but abnormal findings will be referred for further clinical assessment.

Locations (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, China