COPD-PTB Screening Trial in Henan, China

NCT07706972 | Not Yet Recruiting DMC

• 1 other identifier: 2025-244
• Study Type: interventional
• Target: 25,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); TB - Tuberculosis

Keywords

COPD; TB; active case-finding strategy

Outcome Measures

Primary Outcomes (1)

• The prevalence of bacteriologically confirmed PTB

  the third year

Secondary Outcomes (1)

• Diagnosis delay time

  Up to 36 months

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

This cluster receives the intervention during Years 1, 2, and 3.

Other: ACF strategy

Delayed Intervention Group

OTHER

This cluster serves as a no-intervention control during Years 1 and 2, and then transitions to receive the same intervention during Year 3.

Other: ACF strategy

Interventions

ACF strategy OTHER

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

Delayed Intervention Group; Immediate Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older;
• residence in the local area for at least six months;
• providing written informed consent to participate in the study.

You may not qualify if:

• inability to provide informed consent or complete the questionnaire;
• contraindications to CT scanning;
• current pregnancy.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In Year 1, Arm A receive the intervention while Arm B serves as control. In Year 2, Arm A continues with the intervention, Arm B remains control. In Year 3, both Arm A and Arm B receive the intervention.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 16, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share