title: People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov registration number: NCT02082340. Date of registration: 4 March 2014.
authors.affiliation: School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave, Yerevan, 0019, Armenia. vahe.khachadourian@gmail.com.
authors.forename: Vahe
authors.initials: V
authors.lastname: Khachadourian
authors.affiliation: School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave, Yerevan, 0019, Armenia. tnune@aua.am.
authors.forename: Nune
authors.initials: N
authors.lastname: Truzyan
authors.affiliation: School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave, Yerevan, 0019, Armenia. aharutyunyan@aua.am.
authors.forename: Arusyak
authors.initials: A
authors.lastname: Harutyunyan
authors.affiliation: Department of Public Health Sciences, College of Health and Human Services, University of North Carolina at Charlotte, 9201 University City Boulevard, CHHS 427D, Charlotte, NC, 28223-0001, USA. methomp1@uncc.edu.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thompson
authors.affiliation: School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave, Yerevan, 0019, Armenia. tsovinar@aua.am.
authors.forename: Tsovinar
authors.initials: T
authors.lastname: Harutyunyan
authors.affiliation: School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave, Yerevan, 0019, Armenia. vpetrosi@aua.am.
authors.forename: Varduhi
authors.initials: V
authors.lastname: Petrosyan
mesh_terms: D000553:Ambulatory Care; D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001136:Armenia; D002985:Clinical Protocols; D017281:Cost of Illness; D003376:Counseling; D023801:Directly Observed Therapy; D005195:Family Relations; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007407:Interviews as Topic; D055118:Medication Adherence; D010353:Patient Education as Topic; D018802:Patient-Centered Care / Q000379:methods*; D011788:Quality of Life; D017010:Reminder Systems; D012107:Research Design; D012944:Social Support; D011795:Surveys and Questionnaires; D013689:Telephone; D013997:Time Factors; D016896:Treatment Outcome; D014376:Tuberculosis / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology
chemical_list: D000995:Antitubercular Agents