Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578).
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.
Wagner
Glenn J
GJ
RAND Corporation, 1776 Main Street, Santa Monica, CA 90407, USA. gwagner@rand.org
Kanouse
David E
DE
Golinelli
Daniela
D
Miller
Loren G
LG
Daar
Eric S
ES
Witt
Mallory D
MD
Diamond
Catherine
C
Tilles
Jeremiah G
JG
Kemper
Carol A
CA
Larsen
Robert
R
Goicoechea
Miguel
M
Haubrich
Richard H
RH
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
D044966:Anti-Retroviral Agents