Directly observed antiretroviral therapy improves adherence and viral load in drug users attending methadone maintenance clinics: a randomized controlled trial.
OBJECTIVE
To determine if directly observed antiretroviral therapy (DOT) is more efficacious than self-administered therapy for improving adherence and reducing HIV viral load (VL) among methadone-maintained opioid users.


METHODS
Two-group randomized trial.


METHODS
Twelve methadone maintenance clinics with on-site HIV care in the Bronx, New York.


METHODS
HIV-infected adults prescribed combination antiretroviral therapy.


METHODS
Between group differences at four assessment points from baseline to week 24 in: (1) antiretroviral adherence measured by pill count, (2) VL, and (3) proportion with undetectable VL (< 75 copies/ml).


RESULTS
Between June 2004 and August 2007, we enrolled 77 participants. Adherence in the DOT group was higher than in the control group at all post-baseline assessment points; by week 24 mean DOT adherence was 86% compared to 56% in the control group (p < 0.0001). Group differences in mean adherence remained significant after stratifying by baseline VL (detectable versus undetectable). In addition, during the 24-week intervention, the proportion of DOT participants with undetectable VL increased from 51% to 71%.


CONCLUSIONS
Among HIV-infected opioid users, antiretroviral DOT administered in methadone clinics was efficacious for improving adherence and decreasing VL, and these improvements were maintained over a 24-week period. DOT should be more widely available to methadone patients.
Berg
Karina M
KM
Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY 10467, United States.
Litwin
Alain
A
Li
Xuan
X
Heo
Moonseong
M
Arnsten
Julia H
JH
D023241:Antiretroviral Therapy, Highly Active / Q000379:methods* / Q000523:psychology*; D023801:Directly Observed Therapy / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008691:Methadone / Q000627:therapeutic use; D008875:Middle Aged; D058850:Opiate Substitution Treatment / Q000379:methods; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D016320:Substance Abuse Treatment Centers / Q000379:methods; D019562:Viral Load / Q000187:drug effects*; D016903:Drug Monitoring
D008691:Methadone