The Feasibility and Acceptability of a Post-tuberculosis Lung Disease Diagnostic Algorithm in Uganda.

NCT07067528 | Not Yet Recruiting

• 2 other identifiers: MUST-2025-489K43TW012781
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Pulmonary Tuberculosis; Post-Tuberculous Bronchiectasis

Keywords

tuberculosis; bronchiectasis; fibrosis

Outcome Measures

Primary Outcomes (1)

• Primary care interval

  The primary care interval (PCI) is the time (in days) between the date a TB survivor presents at a Health Center III (HC3) with symptoms suggestive of post-tuberculosis lung disease (PTLD) and the date they arrive at the post-TB clinic at Mbarara Regional Referral Hospital (MRRH) for confirmatory diagnosis and care. This time will be calculated using patient records and referral logs. The outcome will be compared between the intervention arm (use of diagnostic algorithm) and control arm (standard clinical judgment).

  Six months

Secondary Outcomes (5)

• Proportion of TB survivors screened for post-TB lung disease (PTLD)

  Six months

• Referral completion rate

  Six months

• Confirmed post-TB lung disease rate

  6 months

• Screening Fidelity

  6 months

• Feasibility of data capture

  6 months

Other Outcomes (1)

• Algorithm usability and acceptability

  At study termination (6 months)

Study Arms (2)

The diagnostic algorithm arm

EXPERIMENTAL

Primary health care facilities (level three health centers in Uganda) randomized to this arm will implement a diagnostic algorithm developed based on clinical and demographic characteristics earlier in this study to screen tuberculosis (TB) survivors for post-tuberculosis lung disease (PTLD). TB clinicians will use a structured questionnaire and visual aid during routine care to identify PTLD. Patients with suspected PTLD will be referred to Mbarara Regional Referral Hospital, a tertiary center with a functional post-TB care clinic for further evaluation and care

Behavioral: A novel PTLD clinical diagnostic algorithm

Standard of care arm

NO INTERVENTION

Primary health care facilities (level three health centres in Uganda) randomized to this arm will continue routine clinical care after receiving basic training through continuous medical education about post-tuberculosis (TB) lung disease (PTLD) but will not use the diagnostic algorithm. TB clinicians will rely on the guideline-based clinical judgment to identify and refer suspected PTLD cases to Mbarara Regional Referral Hospital.

Interventions

A novel PTLD clinical diagnostic algorithm BEHAVIORAL

A clinical diagnostic algorithm designed to help TB clinicians identify patients at risk of post-tuberculosis lung disease (PTLD) at the end of TB treatment. The algorithm is implemented as a visual aid and structured questionnaire integrated into routine care. Clinicians use it to screen TB survivors and refer suspected PTLD cases to a post-TB clinic for confirmatory evaluation and management.

The diagnostic algorithm arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 prior to this screening.

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Mbarara University of Science and Technology/Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

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Related Links

• WHO. Global Tuberculosis report

MeSH Terms

Conditions

Tuberculosis; Bronchiectasis; Fibrosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bronchial Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edwin Nuwagira, MBCh.B

CONTACT

+256779096887; enuwagira@must.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot cluster randomized trial with four primary health care facilities (clusters) randomized 1:1 to either a structured PTLD diagnostic algorithm (intervention) or usual care (control). Each cluster will contribute an estimated 20 participants.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 16, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starts 12 months after publication of primary results and will be available for five years
• Access Criteria: Scientists, Researchers, patients and organizations that care for lung health will be able to access de-identified participant data. Scientific data generated will be archived in the National Institute of Allergy and Infectious Diseases (NIAID)'s TB Portals Program, a web-based, open-access repository of multi-domain tuberculosis data and tools. TB-Portals program is freely accessible through the Registry of Research Data Repositories. Data will be deposited after the publicaton of our clinical trial results. Our study data will be findable through the NIH data repository. All our publications will be open access and will contain a clause to emphasize that our data is freely and easily accessible through the NIH. The global research community will have access for as long as the data is available at the NIH databases. The NIH data repository will have full control on the decisions about how long to preserve the data.

Locations

UG (1)