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NOT YET RECRUITING
NCT07706972
NA

COPD-PTB Screening Trial in Henan, China

Sponsor: Henan Provincial People's Hospital

View on ClinicalTrials.gov

Summary

The goal of this trial is to evaluate the effectiveness of an active case-finding (ACF) strategy for detecting pulmonary tuberculosis (PTB) among patients with chronic obstructive pulmonary disease (COPD) in primary care settings in Henan Province, China. It will also assess the epidemiological status of COPD-PTB comorbidity in this population and evaluate the feasibility of the ACF strategy in real-world primary care settings. This is a stepped-wedge cluster randomized controlled trial. Specifically, the intervention group will receive the ACF strategy in Year 1, Year 2, and Year 3, while the control group will receive routine follow-up care in Year 1 and Year 2, and will transition to receive the ACF intervention in Year 3. All clusters will eventually receive the ACF intervention. The main questions it aims to answer are: Does the ACF strategy decrease the prevalence of PTB among COPD patients compared with routine passive case-finding? What are the current prevalence and epidemiological characteristics of COPD-PTB comorbidity in primary care settings in Henan Province? Participants will: Receive ACF screening during their routine COPD follow-up visits in the intervention phase. Continue their usual COPD care as prescribed by their healthcare providers. If diagnosed with PTB through ACF screening, participants will be referred to designated hospitals for treatment in accordance with the national standardized tuberculosis treatment protocol.

Official title: Epidemiological Status and Intervention Technologies for COPD and Pulmonary Tuberculosis Comorbidity in Primary Care Settings in Henan Province, China

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25000

Start Date

2026-07-20

Completion Date

2029-06-30

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

OTHER

ACF strategy

An ACF strategy integrating computer-aided diagnosis and GeneXpert MTB/RIF testing.