Abstract
BackgroundTuberculosis 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/designInnovative 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.DiscussionImproved 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 registrationClinicalTrials.gov registration number: NCT02082340. Date of registration: 4 March 2014.
Highlights
Tuberculosis is a major public health concern resulting in high rates of morbidity and mortality worldwide, in low- and middle-income countries
Positive findings on effectiveness of this innovative tuberculosis treatment people-centered approach will support its adoption in countries with similar healthcare and economic profiles
Aims and objectives The current randomized controlled trial aims to evaluate the effectiveness of an alternative multicomponent TB outpatient care strategy consisting of the following: 1) education and counseling for drug-sensitive TB patients and their family members, 2) self-administered drugintake supervised by a trained family member, 3) daily Short Message Service (SMS) reminders to TB patients, and 4) daily phone calls to supporting family members
Summary
TB poses a major burden on populations, among those living in low- and middle- income countries. Any improvement in TB treatment strategies can have a significant public health and economic importance. Improved control and management of TB can lead to better treatment outcomes, thereby decreasing health inequalities, morbidity, mortality, and economic costs associated with the disease. Evaluated alternative people-centered strategies, if successful, can be implemented in countries with similar healthcare and economic profiles and help to forestall TB and multidrugresistant TB epidemics. Competing interests The authors declare that they have no competing interests. VK, NT, AH, MET, TH and VP contributed to the study conception and design, and critically revised the manuscript for important intellectual content. VK, NT, and AH contribute to the study implementation and coordinate acquisition of data. All authors read and approved the final manuscript
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