COPD-PTB Screening Trial in Henan, China

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 18 years or older;

residence in the local area for at least six months;

providing written informed consent to participate in the study.

Disqualifiers

inability to provide informed consent or complete the questionnaire;

contraindications to CT scanning;

current pregnancy.

Trial design

Design model

Crossover

Treatments tested in this trial

  • ACF strategy

    Other intervention

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

Treatment groups

25,000 Participants
are divided into 2 treatment groups
Group A: Immediate Intervention GroupExperimental treatment 1 intervention
Group B: Delayed Intervention GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

The prevalence of bacteriologically confirmed PTB

Time frame
the third year

Secondary outcomes

1

Diagnosis delay time

Diagnosis delay is defined as the number of days from the date of the first screening test (e.g., CAD-assisted chest imaging) or the first medical examination for respiratory symptoms (for passive case-finding) to the date of bacteriologically-confirmed PTB diagnosis (positive Xpert MTB/RIF result).

Time frame
Up to 36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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