title: Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578).
abstract: OBJECTIVE
  We conducted a randomized, multi-site, controlled trial of a cognitive-behavioral adherence intervention for patients initiating or changing an antiretroviral (ART) regimen.
  
  
  METHODS
  A 3 x 2 factorial design was used with the primary randomization assigning patients (1: 1: 1) to one of two adherence interventions or usual care.
  
  
  METHODS
  The five-session adherence interventions consisted of cognitive-behavioral and motivational components, with or without a 2-week pre-treatment placebo practice trial. Intent-to-treat analysis used probability weights and regression tree analysis to account for missing data.
  
  
  RESULTS
  A total of 230 patients were randomized; 199 started ART, of whom 74% completed the 48-week study. Electronic monitored adherence outcomes between the two intervention groups did not differ significantly and were thus pooled in analyses. At week 4, 82% of intervention patients had taken at least 90% of their prescribed ART doses, compared with 65% of controls (P < 0.01); this group difference dropped to 12% at week 12 (72 versus 60%; P = 0.15) and 11% at week 24 (66 versus 55%; P = 0.28). Mean adherence in the intervention group was significantly higher than the control group at week 24 (89 versus 81%; P < 0.05) only. There were no group differences with respect to HIV-1 RNA throughout the study.
  
  
  CONCLUSIONS
  The effects of the cognitive-behavioral intervention on adherence were modest and transient, and no effects were observed on viral load or CD4 cell count. More robust effects may require a more intense intervention that combines ongoing adherence monitoring and individualized intervention "dosage" that matches the need and performance of each patient.
authors.affiliation: RAND Corporation, 1776 Main Street, Santa Monica, CA 90407, USA. gwagner@rand.org
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Wagner
authors.forename: David E
authors.initials: DE
authors.lastname: Kanouse
authors.forename: Daniela
authors.initials: D
authors.lastname: Golinelli
authors.forename: Loren G
authors.initials: LG
authors.lastname: Miller
authors.forename: Eric S
authors.initials: ES
authors.lastname: Daar
authors.forename: Mallory D
authors.initials: MD
authors.lastname: Witt
authors.forename: Catherine
authors.initials: C
authors.lastname: Diamond
authors.forename: Jeremiah G
authors.initials: JG
authors.lastname: Tilles
authors.forename: Carol A
authors.initials: CA
authors.lastname: Kemper
authors.forename: Robert
authors.initials: R
authors.lastname: Larsen
authors.forename: Miguel
authors.initials: M
authors.lastname: Goicoechea
authors.forename: Richard H
authors.initials: RH
authors.lastname: Haubrich
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D016009:Chi-Square Distribution; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000523:psychology / Q000628:therapy*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016896:Treatment Outcome; D014481:United States; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents