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Session 104 Poster Abstracts
Adherence, Quality of Life, and Factors Related to Treatment
Friday, 1:30 - 3:30 pm
Hall A


614
Cognitive-behavioral Intervention to Enhance Adherence to ART: A Randomized Clinical Trial (CCTG 578)
Glenn Wagner*1, D Kanouse1, L Miller2, E Daar2, M Witt2, C Diamond3, J Tilles3, C Kemper4, R Larsen5, E Seefried6, A McCutchan6, R Haubrich6, and California Collaborative Treatment Group (CCTG)
1Rand Corp, Santa Monica, CA, USA; 2Harbor-UCLA Med Ctr, Univ of California, Los Angeles, Torrance, USA; 3Univ of California, Irvine, USA; 4Santa Clara Valley Med Ctr, San Jose, CA, USA; 5Univ of Southern California, Los Angeles, USA; and 6Univ of California, San Diego, USA

Background:  Very few controlled HIV adherence interventions trials have been completed and effects have been generally modest and short-lived. We report findings from a randomized, controlled, factorial study of 2 adherence interventions versus usual clinical care in patients initiating or changing an antiretroviral (ART) regimen.

Methods:  We enrolled 230 patients at 5 HIV outpatient clinics and randomized them (1:1:1) to receive 1 of 2 adherence interventions or usual clinical care. The interventions consisted of cognitive, behavioral, and motivational components over 5 weekly sessions, with or without a 2-week pre-treatment practice period taking placebo pills. In addition, patients were also randomized (2:1 within each of the adherence intervention groups) to receive therapeutic drug monitoring (TDM) feedback or not. Stratification was based on prior therapy (ARV-naive versus experienced) and clinic site. Electronic monitoring was the primary method of adherence measurement.

Results:  Adherence outcomes between the 2 intervention groups did not differ significantly and were thus pooled in analyses. At week 4 (2 weeks after the final session), 82% of patients receiving an intervention had taken at least 90% of their prescribed ART doses, compared with 68% of the control group (p < 0.05). The proportion of intervention patients with 90+% adherence dropped to 72% at week 12, but remained stable at 70% at week 24, compared with 61% and 59% of the control group at weeks 12 and 24, respectively. Adherence was significantly correlated with HIV RNA levels over 24 weeks (r = – 0.20), but the intervention groups did not differ in HIV RNA or CD4 levels at baseline or follow-up assessments.

Conclusions:  A 5-week cognitive, behavioral, and motivational intervention increased adherence, but an added pre-treatment practice trial did not improve this effect. With no “booster” sessions to help maintain optimal adherence following the intense initial intervention, the intervention effect dropped at week 12, but then remained stable through week 24.

Keywords: adherence; intervention