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

NCT07067528 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-16

No results posted yet for this study

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

Interventions

BEHAVIORAL

A novel PTLD clinical diagnostic algorithm

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.

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Mbarara University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-08-31
Completion
2029-08-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07067528 on ClinicalTrials.gov