The Feasibility and Acceptability of a Post-tuberculosis Lung Disease Diagnostic Algorithm in Uga… (NCT07067528) | Clinical Trial Compass
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The Feasibility and Acceptability of a Post-tuberculosis Lung Disease Diagnostic Algorithm in Uganda.
Uganda80 participantsStarted 2026-09-01
Plain-language summary
The goal of this clinical trial is to determine whether a structured diagnostic algorithm improves the identification and referral of people with post-tuberculosis lung disease (PTLD) in primary healthcare facilities in Uganda. The clinical trial will, in addition, assess how feasible and acceptable it is for health workers to use this algorithm as part of routine care.
The main trial questions are:
* Does the diagnostic algorithm increase identification and referral of patients with suspected PTLD compared to standard care?
* Is the algorithm feasible to implement and acceptable to health providers and patients in real-world primary health care settings?
The research team will compare four health centre level III (HCIII) facilities ( two using the diagnostic algorithm and two using standard care) to see if the algorithm helps with early diagnosis and referral of PTLD. Health centre level III in Uganda are the primary health facilities and have provision for tuberculosis treatment.
Participants will be screened for PTLD at the time they complete tuberculosis treatment at their local health facility.
At intervention sites, participants will undergo assessment using a structured PTLD diagnostic algorithm developed in earlier stages of this research. The algorithm will be based on a symptom questionnaire and clinical criteria. At control sites, participants will be evaluated using standard practices (consensus clinical definition only).
Participants clinically suspected to have PTLD. will be referred to Mbarara Regional Referral Hospital.
Primary care health facilities will:
* Be randomly assigned to use either the diagnostic algorithm or standard care.
* Receive a baseline training on PTLD and ongoing support through monthly video conference
* Submit triplicate referral forms to track referrals.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A health facility must meet all of the following criteria to participate in the study.
* Located within a 10 km radius of Mbarara Regional Referral Hospital (MRRH).
* Has an operational TB clinic with at least one designated TB clinician or nurse.
* Facility in-charge (or designated representative) provides written informed consent for participation.
* Willing to implement the PTLD screening procedures and participate in biweekly follow-up communications.
* Agrees to assign a contact staff member to coordinate trial-related activities.
Patients screened at participating facilities must meet all of the following:
* Aged ≥18 years.
* Completed microbiologically confirmed treatment for pulmonary tuberculosis (TB).
* Presenting with persistent or new respiratory symptoms following TB treatment completion.
* Able and willing to provide written informed consent
Exclusion Criteria:
A facility will be excluded if:
* It declines to participate or cannot commit to consistent follow-up activities.
* It lacks the minimum staff or infrastructure to carry out screening and referral procedures.
* It was previously included in a similar PTLD-related intervention trial.
A patient will be excluded if:
* They did complete treatment for pulmonary TB or lack documentation of cure.
* They have a previously confirmed diagnosis of an unrelated chronic respiratory condition (e.g., pulmonary malignancy, cystic fibrosis).
* They were already referred or diagnosed with PTLD …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary care interval
Timeframe: Six months
Trial details
NCT IDNCT07067528
SponsorMbarara University of Science and Technology