Intergrated Service Delivery for Lung Health Conditions

NCT07816523 | Active Not Recruiting

• 1 other identifier: STBP/TBREACH/GSA/W11 - 11880
• Study Type: observational
• Target: 20,300
• Locations: 1 country
• Sites: 1

Brief Summary

The Advancing Lung Health in Zambia project aims to improve access to integrated screening, diagnosis, and management of tuberculosis (TB) and other priority respiratory diseases at community and primary healthcare levels. The project recognizes that many lung diseases present with similar symptoms, such as persistent cough, shortness of breath, chest pain, and difficulty breathing. Because of this overlap, focusing on a single disease can result in missed or delayed diagnoses for patients with other serious respiratory conditions. Guided by the World Health Organization's Practical Approach to Lung Health (PAL), the project promotes integrated assessment of people presenting with respiratory symptoms. The main conditions of interest include TB, post-TB lung disease (PTLD), pneumonia, silicosis, and chronic obstructive pulmonary disease (COPD). This approach ensures that patients receive comprehensive evaluation and appropriate care regardless of the underlying cause of their symptoms. A key feature of the project is the use of AI-enabled digital chest X-ray technology to support early and accurate detection of lung abnormalities. The technology assists healthcare workers in identifying signs of TB and other respiratory diseases, improving clinical decision-making and timely referral for further diagnosis and treatment. The project also strengthens healthcare worker capacity, expands access to diagnostic services, enhances community awareness, and improves referral and follow-up systems. In addition, it seeks to generate evidence on the burden and patterns of non-TB respiratory diseases in Zambia while documenting good practices and lessons learned from integrated lung health screening. The evidence generated will help inform policy, strengthen primary healthcare services, and support the scale-up of integrated lung health approaches, ultimately improving respiratory health outcomes and access to quality care across Zambia.

Conditions

TB - Tuberculosis; PTLD; COPD (Chronic Obstructive Pulmonary Disease); Computer Aided Diagnosis

Keywords

Lung Health; Intergrated Service Delivery; Lung Health screening; Respiratory diseases; TB Misdiagnosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Diagnosed With Tuberculosis or Other Respiratory Diseases Through the Integrated Screening and Detection Model

  Total number of participants diagnosed with tuberculosis, post-TB lung disease, silicosis, asthma, COPD, or other respiratory diseases through implementation of the Integrated Screening and Detection model.

  18 Months

Secondary Outcomes (8)

• Number of Individuals Screened for Tuberculosis and Other Respiratory Diseases

  18 months

• Number of Presumptive Tuberculosis Cases Identified

  18 months

• Number of Individuals Evaluated for Tuberculosis

  18 Months

• Number of All-Form Tuberculosis Cases Notified

  18 months

• Number of Bacteriologically Confirmed Tuberculosis Cases Diagnosed

  18 Months

Interventions

Intergrated lung health screening OTHER

We conduct screening for TB and other respiratory diseases through established integrated screening points at community and primary healthcare facilities. All clients undergo both subjective and objective clinical assessment, including symptom screening, medical history review, and physical examination. Individuals are then referred for AI-enabled digital chest X-ray screening to support the detection of lung abnormalities and guide clinical decision-making. Based on the findings from the clinical assessment and chest X-ray, patients are assigned a working diagnosis, which may include tuberculosis (TB), post-TB lung disease (PTLD), pneumonia, chronic obstructive pulmonary disease (COPD), silicosis, or other respiratory conditions. Patients are subsequently investigated and managed according to standardized diagnostic and treatment pathways specific to their suspected condition.

AI-Enabled Cough Sound Screening for Tuberculosis OTHER

Participants will undergo screening using an AI-enabled cough sound analysis tool. Cough sounds will be digitally recorded and analyzed by a machine-learning algorithm trained to identify acoustic patterns associated with pulmonary tuberculosis. The AI-generated screening result will be compared with GeneXpert results, the study reference standard, to determine the tool's diagnostic accuracy. The intervention seeks to evaluate the effectiveness, feasibility, acceptability, and cost implications of using cough sound artificial intelligence as a scalable TB screening strategy within integrated lung health services.

Also known as: Cough Sound analysis

Post-TB Lung Disease evaluation OTHER

This is a nested substudy evaluating participants diagnosed with bacteriologically confirmed TB (with GeneXpert or smear microscopy) will undergo a structured assessment at treatment initiation and at the end of TB treatment to identify post-TB lung disease and related sequelae. Evaluations will include symptom assessment, chest radiography, laboratory investigations (CRP, HbA1c, and FBC), pulmonary function testing (peak flowmetry and spirometry), functional status assessment (sit-to-stand and 2-minute walk tests), and quality-of-life evaluation using the WHOQOL-BREF instrument.

Also known as: Integrated PTLD Assessment Program, Post-TB Lung Health Assessment, PTLD Evaluation and Screening

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The evaluation population comprising individuals receiving services from the five selected TB diagnostic facilities in Kafue District, namely Kafue District Hospital, Nangongwe Health Centre, Railway Clinic, Kafue Estates Clinic, and Chisankane Rural Health Centre, representing the primary TB diagnostic sites within the district. The target population including presumptive TB patients presenting with symptoms suggestive of tuberculosis, household contacts of confirmed TB patients, newly diagnosed people living with HIV (PLHIV), individuals experiencing respiratory symptoms or chronic respiratory conditions, and workers from dust-generating industries facing increased risk of occupational lung diseases such as silicosis. The study evaluating the implementation of integrated service delivery (ISD) for TB and other respiratory diseases among these high-risk populations through facility-based and community-based screening activities.

You may qualify if:

• For the intergrated service delivery screening for lung health conditions:
• Presumptive TB patients (individuals with symptoms or findings suggestive of TB).
• Household contacts of confirmed TB patients.
• Newly diagnosed people living with HIV (PLHIV).
• People with respiratory conditions.
• Workers from dust-generating industries within the district, such as mining and related
• Persons who have a history of cigarrete smoking
• Any person who feels at risk of lung health conditions, with or without symptoms.
• Evaluation of the sound AI screening tool:
• Presumptive TB patient either by symptoms or determined by chest Xray
• Aged 18 and above
• Provides written informed consent to participate in the study
• Post-TB Lung disease sub-study
• Persons diagnosed with bacteriologically confirmed TB with WHO Recommended Rapid Molecular diagnostic tests or sputum smear
• Aged 18 and above

You may not qualify if:

• Evaluation of the sound AI screening tool:
• Aged less than 18
• Does not provide written informed consent
• Not a presumptive TB patient by chest Xray or clinical symptoms.
• Post-TB Lung disease sub-study
• Aged less than 18
• Does not provide written informed consent
• Clinically diagnosed TB.

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• University of Sheffield: collaborator
• Stop TB Partnership's TB REACH initiative: collaborator

Study Sites (1)

Kafue District Hospital, Nangongwe Health Centre, Railway Clinic, Kafue Estates Clinic, and Chisankane Rural Health Centre

Kafue, Lusaka Province, 10101, Zambia

Location

MeSH Terms

Conditions

Latent Tuberculosis; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 11, 2026
• Study Start: March 3, 2025
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

ZA (1)