TB - TuberculosisTB REACH W11NCT07816523
Intergrated Service Delivery for Lung Health Conditions
An observational study of TB - Tuberculosis and PTLD, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- TB - Tuberculosis, PTLD, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Intergrated lung health screening, AI-Enabled Cough Sound Screening for Tuberculosis and Post-TB Lung Disease evaluation
- How many people
- 20,300 participants
- Where
- 1 siteZambia
- Study dates
- 3 Mar 2025to Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
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- Persons who have a history of cigarrete smoking
- Any person who feels at risk of lung health conditions, with or without symptoms.
- For the nested sub-studies the following are the inclusion criteria:
- 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
- Provides written informed consent to participate in the sub-study
Who cannot join
- For the nested sub-studies, the following are the exclusion criteria
- 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
Show all 9Show fewer
- Aged less than 18
- Does not provide written informed consent
- Clinically diagnosed TB.
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Kafue District Hospital, Nangongwe Health Centre, Railway Clinic, Kafue Estates Clinic, and Chisankane Rural Health Centre
Kafue, Lusaka Province, 10101
About this study
Official title: Advancing Lung Health in Zambia Through Increasing Access to Integrated and Comprehensive Screening, Diagnosis and Management of TB and Other Chronic Respiratory Diseases at Community and Primary Care Levels
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.
Read more
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
- Being tested
- Intergrated lung health screening, AI-Enabled Cough Sound Screening for Tuberculosis, Post-TB Lung Disease evaluation
- Keywords
- Lung Health, Intergrated Service Delivery, Lung Health screening, Respiratory diseases, TB Misdiagnosis
- Medical subject headings
- Latent Tuberculosis, Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intergrated lung health screeningOther
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 TuberculosisOther
Also called Cough Sound analysis
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.
Post-TB Lung Disease evaluationOther
Also called Integrated PTLD Assessment Program, Post-TB Lung Health Assessment, PTLD Evaluation and Screening
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 Months
Secondary outcomes (8)
Number of Individuals Screened for Tuberculosis and Other Respiratory Diseases
Total number of individuals screened for tuberculosis and other respiratory diseases through the Integrated Screening and Detection (ISD) model.
Measured: 18 months
Number of Presumptive Tuberculosis Cases Identified
Total number of individuals identified as having presumptive tuberculosis based on screening results through the ISD model.
Measured: 18 months
Number of Individuals Evaluated for Tuberculosis
Total number of individuals who underwent diagnostic evaluation for tuberculosis following identification as presumptive TB cases.
Measured: 18 Months
Number of All-Form Tuberculosis Cases Notified
Total number of tuberculosis cases, including bacteriologically confirmed and clinically diagnosed cases, notified through the ISD model.
Measured: 18 months
Number of Bacteriologically Confirmed Tuberculosis Cases Diagnosed
Total number of tuberculosis cases confirmed by bacteriological testing among individuals evaluated through the ISD model.
Measured: 18 Months
Number of Participants Diagnosed With Other Respiratory Diseases other than Tuberculosis
Total number of participants diagnosed with other respiratory diseases, including post-TB lung disease (PTLD), silicosis, asthma, and chronic obstructive pulmonary disease (COPD), through the ISD model.
Measured: 18 Months
The Prevalence of Post-Tuberculosis Lung Disease (PTLD)
Proportion of individuals with bacteriologically confirmed TB completing TB treatment who meet the criteria for post-TB lung disease at the end of treatment. Assessment will include persistent respiratory symptoms, radiological abnormalities, lung function impairment, exercise limitation, and quality-of-life measures.
Measured: From Enrollment at the start of TB treatment up to the end of treatment in 6 months
Diagnostic Accuracy of the AI-Enabled Cough Sound Screening Tool for Tuberculosis (Sub-Study)
Diagnostic accuracy of the AI-enabled cough sound screening tool for tuberculosis, measured by sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC), using GeneXpert as the reference standard.
Measured: Each participant spends approximately 30 minutes to 2 hours participating in the evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start3 Mar 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TB - TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20,300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, Stop TB Partnership's TB REACH initiative
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816523
- Sponsor's protocol ID
- STBP/TBREACH/GSA/W11 - 11880
- Acronym
- TB REACH W11
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Lung Health in Zambia Through Increasing Access to Integrated and Comprehensive Screening, Diagnosis and Management of TB and Other Chronic Respiratory Diseases at Community and Primary Care Levels
- ClinicalTrials.gov ID
- NCT07816523
- Acronym / sponsor ID
- TB REACH W11 / STBP/TBREACH/GSA/W11 - 11880
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,300 participants (estimated)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- University of Sheffield, Stop TB Partnership's TB REACH initiative
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (9 listed)
- For the nested sub-studies, the following are the exclusion criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intergrated lung health screeningWe 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. | Other | – |
| AI-Enabled Cough Sound Screening for TuberculosisAlso: Cough Sound analysisParticipants 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. | Other | – |
| Post-TB Lung Disease evaluationAlso: Integrated PTLD Assessment Program, Post-TB Lung Health Assessment, PTLD Evaluation and ScreeningThis 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. | Other | – |
Primary outcome
Number of Participants Diagnosed With Tuberculosis or Other Respiratory Diseases Through the Integrated Screening and Detection Model
Time frame: 18 Months
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.
8 secondary outcomes
Number of Individuals Screened for Tuberculosis and Other Respiratory Diseases
Time frame: 18 months
Number of Presumptive Tuberculosis Cases Identified
Time frame: 18 months
Number of Individuals Evaluated for Tuberculosis
Time frame: 18 Months
Number of All-Form Tuberculosis Cases Notified
Time frame: 18 months
Number of Bacteriologically Confirmed Tuberculosis Cases Diagnosed
Time frame: 18 Months
Number of Participants Diagnosed With Other Respiratory Diseases other than Tuberculosis
Time frame: 18 Months
The Prevalence of Post-Tuberculosis Lung Disease (PTLD)
Time frame: From Enrollment at the start of TB treatment up to the end of treatment in 6 months
Diagnostic Accuracy of the AI-Enabled Cough Sound Screening Tool for Tuberculosis (Sub-Study)
Time frame: Each participant spends approximately 30 minutes to 2 hours participating in the evaluation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TB - Tuberculosis and PTLD, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Diagnosed With Tuberculosis or Other Respiratory Diseases Through the Integrated Screening and Detection Model (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.