RecruitingNot ApplicableNCT06702774

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

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


Sponsor

University of Toronto

Enrollment

72,000 participants

Start Date

Nov 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 Years

Inclusion Criteria3

  • all residents who are elderly (i.e., aged 65 and above)
  • all residents who are aged 15 to 64 with one of the following conditions: being patients previously treated for TB or close contacts of a patient with a TB patient diagnosed within the last three years; having been clinically diagnosed with diabetes, HIV positive, or worked as a miner
  • Have signed consent form

Exclusion Criteria1

  • Residents who refuse participation.

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Interventions

DIAGNOSTIC_TESTActive 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

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NCT06702774


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