title: Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.
abstract: Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB) treatment adherence based on Health Belief Model (HBM).
  
  
  
  A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs) (14 HCs intervention and 16 HCs control groups). A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence.
  
  
  
  At enrollment, the level of non-adherence among intervention (19.4%) and control (19.6%) groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline) to 9.5% (at endpoint), while it increased among control group from 19.4% (baseline) to 25.4% (endpoint). Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI) (0.18-0.53), p < 0.001)).
  
  
  
  Psychological counseling and educational interventions, which were guided by HBM, significantly decreased treatment non-adherence level among intervention group. Provision of psychological counseling and health education to TB patients who are on regular treatment is recommended. This could be best achieved if these interventions are guided by behavioral theories and incorporated into the routine TB treatment strategy.
  
  
  
  Pan African Clinical Trials Registry PACTR201506001175423.
authors.affiliation: Tehran University of Medical Sciences-International Campus, School of Public Health, Department of Health Education and Promotion, Tehran, Iran.|Ethiopian Public Health Institute, TB/HIV Research Directorate, Addis Ababa, Ethiopia.
authors.forename: Habteyes Hailu
authors.identifier: 0000-0002-2889-956X
authors.initials: HH
authors.lastname: Tola
authors.affiliation: Tehran University of Medical Sciences-International Campus, School of Public Health, Department of Health Education and Promotion, Tehran, Iran.
authors.forename: Davoud
authors.initials: D
authors.lastname: Shojaeizadeh
authors.affiliation: Tehran University of Medical Sciences-International Campus, School of Public Health, Department of Health Education and Promotion, Tehran, Iran.
authors.forename: Azar
authors.initials: A
authors.lastname: Tol
authors.affiliation: Tehran University of Medical Sciences-International Campus, School of Public Health, Department of Health Education and Promotion, Tehran, Iran.
authors.forename: Gholamreza
authors.initials: G
authors.lastname: Garmaroudi
authors.affiliation: Tehran University of Medical Sciences International Campus, School of Public Health, Department of Epidemiology and Biostatistics, Tehran, Iran.
authors.forename: Mir Saeed
authors.initials: MS
authors.lastname: Yekaninejad
authors.affiliation: Ethiopian Public Health Institute, TB/HIV Research Directorate, Addis Ababa, Ethiopia.
authors.forename: Abebaw
authors.initials: A
authors.lastname: Kebede
authors.affiliation: Tehran University of Medical Sciences-International Campus, School of Public Health, Department of Health Education and Promotion, Tehran, Iran.
authors.forename: Luche Tadesse
authors.initials: LT
authors.lastname: Ejeta
authors.affiliation: Ethiopian Public Health Institute, TB/HIV Research Directorate, Addis Ababa, Ethiopia.
authors.forename: Desta
authors.initials: D
authors.lastname: Kassa
authors.affiliation: KNCV Tuberculosis Foundation, The Hague, The Netherlands.|Department of Global Health, Academic Medical Centre, University of Amsterdam, Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
authors.forename: Eveline
authors.initials: E
authors.lastname: Klinkenberg
mesh_terms: D000293:Adolescent; D000328:Adult; D003469:Culture; D023381:Endpoint Determination; D005002:Ethiopia; D005260:Female; D006262:Health; D006266:Health Education; D006801:Humans; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D008962:Models, Theoretical; D055361:Multilevel Analysis; D016017:Odds Ratio; D010349:Patient Compliance; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy* / Q000523:psychology*; D055815:Young Adult