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

NCT06702774 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72000

Last updated 2024-12-06

No results posted yet for this study

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.

Conditions

  • Tuberculosis (TB)

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.

Sponsors & Collaborators

  • Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

    collaborator UNKNOWN

  • University of Toronto

    lead OTHER

Principal Investigators

  • Dabin Liang, PhD · Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

  • Xiaolin Wei, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-20
Primary Completion
2025-01-31
Completion
2025-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702774 on ClinicalTrials.gov