Supervised dosing is a cornerstone of tuberculosis treatment. HIV treatment strategies that use directly administered antiretroviral therapy (DAART) are increasingly being assessed. In a prospective single-arm clinical trial, we enrolled methadone-maintained, HIV-infected participants to receive supervised doses of antiretroviral therapy (ART) on days when they received methadone. Other ART doses were self-administered. In this analysis we examined factors associated with retention to DAART, adherence to supervised doses, and virologic failure. Factors associated with retention to DAART were assessed with the Kaplan-Meier method and Cox proportional hazards models. Factors associated with nonadherence with supervised dosing and with virologic failure were assessed by logistic regression and techniques for longitudinal data analysis. A total of 16,453 supervised doses were administered to 88 participants over a median follow-up of 9.4 months. The median participant adherence with supervised dosing was 83%. Active drug use, determined by urine drug screens, was associated twofold increased risks of both intervention dropout and nonadherence with supervised doses. Adherence with supervised doses was strongly associated with virologic failure. Because DAART was administered only on methadone dosing days, fewer than half of the total ART doses were scheduled to be supervised in most participants. The percent of doses that was scheduled to be supervised was not associated with either adherence or with virologic failure. Given that a relatively small proportion of the total ART doses were supervised in many patients, future studies should assess how DAART affects adherence with nonsupervised doses and retention to ART.
"Avants, Margolin, Warburton, Hawkins, and Shi (2001), for example found that more than a third of HIV-positive patients receiving methadone maintenance treatment reported less than 80% adherence to their HIV medication regimens, a rate that potentially increases the risk of developing a drug-resistant strain of the virus. Even when ART doses were directly administered and supervised in a methadone clinic-based program, continued substance use was associated with an increased risk of nonadherence and intervention dropout (Lucas et al., 2007). "
[Show abstract][Hide abstract] ABSTRACT: Depression and substance use, the most common comorbidities with HIV, are both associated with poor treatment adherence. Injection drug users comprise a substantial portion of individuals with HIV in the United States and globally. The present study tested cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with HIV and depression in active substance abuse treatment for injection drug use.
This is a 2-arm, randomized controlled trial (N = 89) comparing CBT-AD with enhanced treatment as usual (ETAU). Analyses were conducted for two time-frames: (a) baseline to post-treatment and (b) post-treatment to follow-up at 3 and 6 months after intervention discontinuation.
At post-treatment, the CBT-AD condition showed significantly greater improvement than ETAU in MEMS (electronic pill cap) based adherence, γslope = 0.8873, t(86) = 2.38, p = .02; dGMA-raw = 0.64, and depression, assessed by blinded assessor: Mongomery-Asberg Depression Rating Scale, F(1, 79) = 6.52, p < .01, d = 0.55; clinical global impression, F(1, 79) = 14.77, p < .001, d = 0.85. After treatment discontinuation, depression gains were maintained, but adherence gains were not. Viral load did not differ across condition; however, the CBT-AD condition had significant improvements in CD4 cell counts over time compared with ETAU, γslope = 2.09, t(76) = 2.20, p = .03, dGMA-raw = 0.60.
In patients managing multiple challenges including HIV, depression, substance dependence, and adherence, CBT-AD is a useful way to integrate treatment of depression with an adherence intervention. Continued adherence counseling is likely needed, however, to maintain or augment adherence gains in this population.
Journal of Consulting and Clinical Psychology 04/2012; 80(3):404-15. DOI:10.1037/a0028208 · 4.85 Impact Factor
"In our mDOT intervention, only some doses of ribavirin are observed. However, in one study of directly observed antiretroviral therapy among HIV-infected subjects, the percent of observed doses was not associated with virologic failure , suggesting that even minimal participation in a DOT program may improve antiretroviral adherence. In addition, some aspects of our study design may improve adherence in the TAU arm, and therefore reduce our measured effect size. "
[Show abstract][Hide abstract] ABSTRACT: Most methadone-maintained injection drug users (IDUs) have been infected with hepatitis C virus (HCV), but few initiate HCV treatment. Physicians may be reluctant to treat HCV in IDUs because of concerns about treatment adherence, psychiatric comorbidity, or ongoing drug use. Optimal HCV management approaches for IDUs remain unknown. We are conducting a randomized controlled trial in a network of nine methadone clinics with onsite HCV care to determine whether modified directly observed therapy (mDOT), compared to treatment as usual (TAU), improves adherence and virologic outcomes among opioid users.
We plan to enroll 80 HCV-infected adults initiating care with pegylated interferon alfa-2a (IFN) plus ribavirin, and randomize them to mDOT (directly observed daily ribavirin plus provider-administered weekly IFN) or TAU (self-administered ribavirin plus provider-administered weekly IFN). Our outcome measures are: 1) self-reported and pill count adherence, and 2) end of treatment response (ETR) or sustained viral response (SVR). We will use mixed effects linear models to assess differences in pill count adherence between treatment arms (mDOT v. TAU), and we will assess differences between treatment arms in the proportion of subjects with ETR or SVR with chi square tests. Of the first 40 subjects enrolled: 21 have been randomized to mDOT and 19 to TAU. To date, the sample is 77% Latino, 60% HCV genotype-1, 38% active drug users, and 27% HIV-infected. Our overall retention rate at 24 weeks is 92%, 93% in the mDOT arm and 92% in the TAU arm.
This paper describes the design and rationale of a randomized clinical trial comparing modified directly observed HCV therapy delivered in a methadone program to on-site treatment as usual. Our trial will allow rigorous evaluation of the efficacy of directly observed HCV therapy (both pegylated interferon and ribavirin) for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs, and can also guide protocols for studies among HCV-infected drug users receiving methadone for opiate dependence.
"This study is designed to assess the efficacy of DAART compared to SAT among HIV-infected subjects attending OTPs for maintenance methadone or buprenorphine therapy, and builds upon our developmental work with DAART in this setting [7,18]. Our study is the second randomized controlled trial of DAART in OTPs. "
[Show abstract][Hide abstract] ABSTRACT: HIV-infected drug users are at higher risk of non-adherence and poor treatment outcomes than HIV-infected non-drug users. Prior work from our group and others suggests that directly administered antiretroviral therapy (DAART) delivered in opioid treatment programs (OTPs) may increase rates of viral suppression.
We are conducting a randomized trial comparing DAART to self-administered therapy (SAT) in 5 OTPs in Baltimore, Maryland. Participants and investigators are aware of treatment assignments. The DAART intervention is 12 months. The primary outcome is HIV RNA < 50 copies/mL at 3, 6, and 12 months. To assess persistence of any study arm differences that emerge during the active intervention, we are conducting an 18-month visit (6 months after the intervention concludes). We are collecting electronic adherence data for 2 months in both study arms. Of 457 individuals screened, a total of 107 participants were enrolled, with 56 and 51 randomly assigned to DAART and SAT, respectively. Participants were predominantly African American, approximately half were women, and the median age was 47 years. Active use of cocaine and other drugs was common at baseline. HIV disease stage was advanced in most participants. The median CD4 count at enrollment was 207 cells/mm3, 66 (62%) had a history of an AIDS-defining opportunistic condition, and 21 (20%) were antiretroviral naïve.
This paper describes the rationale, methods, and baseline characteristics of subjects enrolled in a randomized clinical trial comparing DAART to SAT in opioid treatment programs.
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