About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Residents who refuse participation.
Trial design
Parallel
Treatments tested in this trial
Active case finding
Diagnostic testVillagers 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.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence rate of bacteriologically positive TB
Prevalence rate of bacteriologically positive TB in Year 3 among the high-risk populations , including those of 65 and older, those who are under 65 but have a history of tuberculosis treatment or have been in close contact with a person diagnosed of TB within the past three years, have been clinically diagnosed with diabetes, HIV, or have a background of working as a miner.
Secondary outcomes
Prevalence rate of active TB
Prevalence rate of active TB, including both bacteriologically positive and negative cases, among the high-risk populations in Year 3
Notification rates of bacteriologically positive TB
Notification rates of bacteriologically positive TB cases among all populations in Year 3
Notification rates of active TB cases
Notification rates of active TB cases, including both bacteriologically positive and negative cases among all populations in Year 3
Sponsors and contacts
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University of Toronto
Lead sponsor
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Collaborator