Active case finding using mobile vans equipped with artificial intelligence aided radiology tests and sputum collection for rapid diagnostic tests to reduce tuberculosis prevalence in rural China: protocol for a pragmatic trial

BackgroundTuberculosis (TB) remains a significant public health challenge, particularly in rural areas of high-burden countries like China. Active case finding (ACF) and timely treatment has been proved effective in reducing TB prevalence but it is still unknown regarding the impact on TB epidemic when employing new technologies in ACF. This study aims to evaluate the effectiveness of a comprehensive ACF package utilizing mobile vans equipped with artificial intelligence (AI)-aided radiology, and GeneXpert testing in reducing TB prevalence among high-risk populations in rural Guangxi, China. MethodsA pragmatic cluster randomized controlled trial will be conducted in two counties of Guangxi, China. The trial will randomize 23 townships to intervention or control groups at 1:1 ratio. The intervention group will receive a single ACF campaign in Year 1, incorporating mobile vans, AI-based DR screening, symptom assessment, and sputum collection for GeneXpert testing. Control group participants will receive usual care. TB patients identified in Year 1 will be required to complete TB treatment in Year 2. The primary outcome is the prevalence rate of bacteriologically confirmed TB among high-risk populations in Year 3. Process evaluation will explore adaption, acceptability and feasibility of the intervention. We will conduct incremental costing study to inform future scale-up of the intervention in other settings. DiscussionThis study will provide valuable insights into the effectiveness and feasibility of utilizing AI, mobile vans and GeneXpert for TB ACF to reduce TB prevalence in rural settings. If successful, this model will contribute to possible solutions to achieve the WHO End TB Strategy by 2035. Trial registration: ClinicalTrials.gov Identifier -NCT06702774