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.
Mbarara University of Science and Technology
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator