We conducted a randomized, multi-site, controlled trial of a cognitive-behavioral adherence intervention for patients initiating or changing an antiretroviral (ART) regimen.
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.
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.
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.
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.
"While this finding could be attributable simply to the five mDOT visits per week where ingestion of doses were directly observed, nearly half of participants were on twice or thrice a day dosing schedules meaning that they self-administered more than half of their doses outside of mDOT visits. These findings are more consistent with the notion that more intervention is associated with better adherence [11, 33–37]. Nevertheless, the lack of significant main effect findings underscores how even intensive interventions can fail to substantially improve adherence over high quality SC. "
[Show abstract][Hide abstract] ABSTRACT: This study determined whether motivational interviewing-based cognitive behavioral therapy (MI-CBT) adherence counseling combined with modified directly observed therapy (MI-CBT/mDOT) is more effective than MI-CBT counseling alone or standard care (SC) in increasing adherence over time. A three-armed randomized controlled 48-week trial with continuous electronic drug monitored adherence was conducted by randomly assigning 204 HIV-positive participants to either 10 sessions of MI-CBT counseling with mDOT for 24 weeks, 10 sessions of MI-CBT counseling alone, or SC. Poisson mixed effects regression models revealed significant interaction effects of intervention over time on non-adherence defined as percent of doses not-taken (IRR = 1.011, CI = 1.000-1.018) and percent of doses not-taken on time (IRR = 1.006, CI = 1.001-1.011) in the 30 days preceding each assessment. There were no significant differences between groups, but trends were observed for the MI-CBT/mDOT group to have greater 12 week on-time and worse 48 week adherence than the SC group. Findings of modest to null impact on adherence despite intensive interventions highlights the need for more effective interventions to maintain high adherence over time.
AIDS and Behavior 04/2013; 17(6). DOI:10.1007/s10461-013-0467-3 · 3.49 Impact Factor
"The focus of this study was on non-methadone substance abuse treatment so studies conducted in methadone maintenance programs were not considered in this analysis. From the 1579 participants in the MACH14 dataset, we identified 215 from two studies based outside methadone clinics
[10,11] because only these two studies’ participants had both EDM and substance abuse treatment status data. Written informed consent was obtained for participation in the parent studies, and the Yale Institutional Review Board approved the secondary analyses. "
[Show abstract][Hide abstract] ABSTRACT: Background
Opiate substitution treatment has been associated with better adherence to lifesaving antiretroviral medications, but the impact of other substance abuse treatment on adherence is unknown.
In this study, 215 patients who had been in adherence-focused research studies provided electronically-measured adherence data and a measure of whether the patient had recently been in substance abuse treatment. Recent engagement in substance abuse treatment was independently associated with significantly higher adherence, after covarying for recent substance use and other factors potentially affecting adherence.
The findings suggest that substance abuse treatment is associated with better adherence. Potential mechanisms by which substance abuse treatment improves adherence, such as more stability or more future-orientation, require further study.
AIDS Research and Therapy 10/2012; 9(1):30. DOI:10.1186/1742-6405-9-30 · 1.46 Impact Factor
"To date, there is no evidence that low adherence can be remedied in a definitive manner. Therefore, strategies to enhance adherence should be continued throughout the treatment period  and include periodical actions aimed at enhancing adherence, particularly among individuals who struggle to manage their treatment [29, 53]. "
[Show abstract][Hide abstract] ABSTRACT: To assess the effectiveness of a psychosocial individual intervention to improve adherence to ART in a Brazilian reference-center, consenting PLHIV with viral load >50 copies/ml were selected. After 4 weeks of MEMS cap use, participants were randomized into an intervention group (IG) (n = 64) or control group (CG) (n = 57). CG received usual care only. The IG participated in a human rights-based intervention approach entailing four dialogical meetings focused on medication intake scenes. Comparison between IG and CG revealed no statistically significant difference in adherence measured at weeks 8, 12, 16, 20 and 24. Viral load (VL) decreased in both groups (p < 0.0001) with no significant difference between study groups. The lower number of eligible patients than expected underpowered the study. Ongoing qualitative analysis should provide deeper understanding of the trial results. NIH Clinical Trials: NCTOO716040.
AIDS and Behavior 04/2012; 17(1). DOI:10.1007/s10461-012-0175-4 · 3.49 Impact Factor
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