TY - JOUR
T1 - Rationale, design, and sample characteristics of a randomized controlled trial of directly observed antiretroviral therapy delivered in methadone clinics
AU - Berg, Karina M.
AU - Mouriz, Jennifer
AU - Li, Xuan
AU - Duggan, Elise
AU - Goldberg, Uri
AU - Arnsten, Julia H.
N1 - Funding Information:
The core components of our DOT program did not require additional funding over existing clinic operating budgets. We did not provide salary support for medical providers, nurses or adherence counselors, and antiretroviral medications were paid for by patients' existing insurance plans. We did supply pillboxes used for DOT, and we paid the DoSA central pharmacist a stipend to fill the pillboxes; however, these devices are widely available and inexpensive. Funding for the research aspects of this DOT program (e.g., salaries for research staff, computers for interviews, and MEMS caps) was provided by a grant from the National Institutes of Health (NIDA R01 DA015302).
PY - 2009/9
Y1 - 2009/9
N2 - Background: Directly observed therapy (DOT) programs for HIV treatment have demonstrated feasibility, acceptability, and improved viral suppression, but few have been rigorously tested. We describe a randomized controlled trial testing the efficacy of an antiretroviral DOT program in methadone maintenance clinics. Our objective was to determine if DOT is more efficacious than self-administered antiretroviral therapy for reducing HIV viral load, improving adherence, and reducing drug resistance among opioid dependent drug users receiving methadone treatment. Methods: Participants were randomized to treatment as usual (TAU) or antiretroviral DOT for the 24-week intervention. TAU participants received standard adherence counseling, and DOT participants received standard adherence counseling plus directly observed antiretroviral therapy, which was delivered at the same time as they received daily methadone. Assessments occurred at baseline, weekly for 8 weeks, and then monthly for 4 months. Our primary outcomes were between-group changes from baseline to the end of the intervention in: HIV viral load, antiretroviral adherence, and number of viral mutations. Results: Between June 2004 and August 2007, we screened 3231 methadone-maintained patients and enrolled 77; 39 participants were randomized to DOT and 38 to TAU. 65 completed the 24-week intervention. Conclusions: Our trial will allow rigorous evaluation of the efficacy of directly observed antiretroviral therapy delivered in methadone clinics 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 guide protocols for studies among HIV-infected drug users receiving methadone for opioid dependence.
AB - Background: Directly observed therapy (DOT) programs for HIV treatment have demonstrated feasibility, acceptability, and improved viral suppression, but few have been rigorously tested. We describe a randomized controlled trial testing the efficacy of an antiretroviral DOT program in methadone maintenance clinics. Our objective was to determine if DOT is more efficacious than self-administered antiretroviral therapy for reducing HIV viral load, improving adherence, and reducing drug resistance among opioid dependent drug users receiving methadone treatment. Methods: Participants were randomized to treatment as usual (TAU) or antiretroviral DOT for the 24-week intervention. TAU participants received standard adherence counseling, and DOT participants received standard adherence counseling plus directly observed antiretroviral therapy, which was delivered at the same time as they received daily methadone. Assessments occurred at baseline, weekly for 8 weeks, and then monthly for 4 months. Our primary outcomes were between-group changes from baseline to the end of the intervention in: HIV viral load, antiretroviral adherence, and number of viral mutations. Results: Between June 2004 and August 2007, we screened 3231 methadone-maintained patients and enrolled 77; 39 participants were randomized to DOT and 38 to TAU. 65 completed the 24-week intervention. Conclusions: Our trial will allow rigorous evaluation of the efficacy of directly observed antiretroviral therapy delivered in methadone clinics 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 guide protocols for studies among HIV-infected drug users receiving methadone for opioid dependence.
KW - Antiretroviral therapy
KW - Directly observed therapy
KW - HIV
KW - Medication adherence
KW - Methadone
KW - Randomized trial
KW - Substance abuse treatment
UR - http://www.scopus.com/inward/record.url?scp=68349101321&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=68349101321&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2009.05.003
DO - 10.1016/j.cct.2009.05.003
M3 - Article
C2 - 19505589
AN - SCOPUS:68349101321
SN - 1551-7144
VL - 30
SP - 481
EP - 489
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 5
ER -