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.
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.
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.
They did complete treatment for pulmonary TB or lack documentation of cure.
Parallel
A novel PTLD clinical diagnostic algorithm
BehavioralA 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.
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).
Proportion of TB survivors screened for post-TB lung disease (PTLD)
The proportion of TB survivors declared cured who are screened for post-TB lung disease (PTLD) at participating HC3s. This will be presented as a percentage.
Referral completion rate
Proportion of TB survivors referred to Mbarara Regional Referral Hospital (MRRH) who successfully arrive at the post-TB clinic for evaluation. This proportion will include all referred patients from participating HC3s
Confirmed post-TB lung disease rate
Proportion of referred patients who receive a confirmed diagnosis of PTLD at Mbarara regional referral hospital post-TB clinic using imaging and/or spirometry.
Screening Fidelity
Implementation fidelity of post-TB lung disease (PTLD) screening, defined as the proportion of eligible TB survivors screened using either the diagnostic algorithm (intervention arm) or clinical judgment (control arm).
Algorithm usability and acceptability
Proportion of clinicians in the intervention arm who report that the diagnostic algorithm was easy to use and helpful in clinical decision-making.
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Mbarara University of Science and Technology
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
