Cluster randomized trial of an integrated care and results-based financing intervention to improve adherence among patients with drug-susceptible and drug-resistant tuberculosis in Georgia

Curatio International Foundation0 sites1,153 target enrollmentJanuary 14, 2019

Overview

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30987995 realist evaluation protocol 2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31462284 protocol (added 30/08/2019)

Registry

who.int

Start Date

January 14, 2019

End Date

July 1, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Curatio International Foundation

•1\. Aged \=18
•2\. All new or previously treated patients with pulmonary TB
•3\. Assigned to outpatient TB treatment not more than one month prior to enrolment in the study; This restriction (not more than one month treatment) does not refer to patients whose most recent treatment outcome was failure and who were assigned to a new treatment regimen
•4\. Assigned to outpatient TB treatment at outpatient facility or at home (through DOT) according to the national TB treatment guidelines
•5\. TB diagnosis established by a direct sputum smear microscopy, culture or Gene Xpert MTB/RIF (bacteriologically confirmed case), OR TB diagnosis established by an X\-ray, histological or morphological changes (clinically diagnosed case)

•1\. TB outpatient treatment started more than one month prior to enrolment in the study
•2\. Patients with extra\-pulmonary TB
•3\. Patients with DS\-TB with more than two months of hospitalisation or patients with DR\-TB with more than 6 months of hospitalisation
•4\. Patients known at the start of treatment to require the treatment longer than it is recommended by the Georgian TB Management Guidelines for the appropriate type of TB
•5\. Custody patients
•6\. Patients involved in other clinical studies related to TB treatment
•7\. Patients with intention to leave the place within next 6 months