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NCT07067528
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The Feasibility and Acceptability of a Post-tuberculosis Lung Disease Diagnostic Algorithm in Uganda.

Sponsor: Mbarara University of Science and Technology

View on ClinicalTrials.gov

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.

Official title: The Feasibility and Acceptability of a Diagnostic Algorithm for Timely Post-tuberculosis Lung Disease Diagnosis at Primary Health Care Facilities in Mbarara, Uganda.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-09-01

Completion Date

2029-08-31

Last Updated

2025-07-16

Healthy Volunteers

No

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.

Locations (1)

Mbarara University of Science and Technology/Mbarara Regional Referral Hospital

Mbarara, Uganda