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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial

Authors: Vahe Khachadourian, Nune Truzyan, Arusyak Harutyunyan, Michael E. Thompson, Tsovinar Harutyunyan, Varduhi Petrosyan

Published in: Trials | Issue 1/2015

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Abstract

Background

Tuberculosis is a major public health concern resulting in high rates of morbidity and mortality worldwide, particularly in low- and middle-income countries. Tuberculosis requires a long and intensive course of treatment. Thus, various approaches, including patient empowerment, education and counselling sessions, and involvement of family members and community workers, have been suggested for improving treatment adherence and outcome. The current randomized controlled trial aims to evaluate the effectiveness over usual care of an innovative multicomponent people-centered tuberculosis-care strategy in Armenia.

Methods/design

Innovative Approach to Tuberculosis care in Armenia is an open-label, stratified cluster randomized controlled trial with two parallel arms. Tuberculosis outpatient centers are the clusters assigned to intervention and control arms. Drug-sensitive tuberculosis patients in the continuation phase of treatment in the intervention arm and their family members participate in a short educational and counselling session to raise their knowledge, decrease tuberculosis-related stigma, and enhance treatment adherence. Patients receive the required medications for one week during the weekly visits to the tuberculosis outpatient centers. Additionally, patients receive daily Short Message Service (SMS) reminders to take their medications and daily phone calls to assure adherence and monitoring of treatment potential side effects. Control-arm patients follow the World Health Organization - recommended directly observed treatment strategy, including daily visits to tuberculosis outpatient centers for drug-intake. The primary outcome is physician-reported treatment outcome. Patients’ knowledge, depression, quality of life, within-family tuberculosis-related stigma, family social support, and self-reported adherence to tuberculosis treatment are secondary outcomes.

Discussion

Improved adherence and tuberculosis treatment outcomes can strengthen tuberculosis control and thereby forestall tuberculosis and multidrug resistant tuberculosis epidemics. Positive findings on effectiveness of this innovative tuberculosis treatment people-centered approach will support its adoption in countries with similar healthcare and economic profiles.

Trial registration

ClinicalTrials.gov registration number: NCT02082340. Date of registration: 4 March 2014.
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Metadata
Title
People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial
Authors
Vahe Khachadourian
Nune Truzyan
Arusyak Harutyunyan
Michael E. Thompson
Tsovinar Harutyunyan
Varduhi Petrosyan
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0802-2

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