NCT07067528Not yet recruiting
The Feasibility and Acceptability of a Post-tuberculosis Lung Disease Diagnostic Algorithm in Uganda.
The Feasibility and Acceptability of a Diagnostic Algorithm for Timely Post-tuberculosis Lung Disease Diagnosis at Primary Health Care Facilities in Mbarara, Uganda.
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Mbarara University of Science and Technology
- Diseases
- Tuberculosis
- NCT number
- NCT07067528
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Sept 2026 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- It was previously included in a similar PTLD-related intervention trial.
- A patient will be excluded if:
- 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 prior to this screening.
Other
- 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.
- They did complete treatment for pulmonary TB or lack documentation of cure.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mbarara University of Science and Technology/Mbarara Regional Referral Hospital Coordinator of this site? Confirm its status | Mbarara | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.