Opulations. Medication assisted therapy with methadone or buprenorphine in opioid treatment
Opulations. Medication assisted therapy with methadone or buprenorphine in opioid treatment programs (OTPs) is effective treatment for opioid addiction, and entails frequent contact with patients that may facilitate DAART [5,6]. Based on developmental work at our center [7], we hypothesized that providing DAART to HIV-infected?2011 Mullen et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Mullen et al. BMC Infectious Diseases 2011, 11:45 http://www.biomedcentral.com/1471-2334/11/Page 2 ofindividuals in OTPs would be effective and sustainable. To address this question we designed a randomized controlled trial of DAART compared with SAT. In this paper we describe the rationale, methods, and baseline characteristics of subjects enrolled in our study.MethodsDesignThe study is a randomized, non-blinded trial comparing DAART and SAT in HIV-infected participants who are receiving medication assisted treatment at 1 of 5 OTPs in Baltimore, Maryland. In the DAART intervention, study assistants observe PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/28494239 morning doses of antiretroviral therapy (ART) on weekdays when participants attend the OTP; other doses are self-administered. Participants in the control arm self-administer all doses. The primary outcome is viral load suppression, measured at 3, 6, and 12 months. We provide DAART for up to 12 months, after which participants assigned to this arm convert to self-administration. We follow participants to 18 months to assess the potential persistence of any benefits realized during the intervention period.Settingprotease inhibitor, non-nucleoside reverse transcriptase inhibitor, abacavir, or integrase inhibitor. Additionally, we required verbal agreement to participate from participants’ HIV medical providers. Exclusion criteria included stable ART use with HIV RNA < 500 copies/ mL, ART dosed more frequently than twice daily, use of liquid antiretroviral preparations, participation in another HIV adherence program in which medication is directly administered, or fewer than 1.5 `active' drugs in the specified regimen - as predicted by prior genotypic resistance tests (if available) and mutation interpretation guidelines [9].Participant RecruitmentWe enrolled participants from 5 OTPs in Baltimore between May 2006 and May 2010. Initially, the study began with three sites (1, 2, and 3). However, we discontinued recruitment at site 3 due to slow enrollment and replaced it with sites 4 and 5 in August 2007 and August 2008, respectively. Three programs were hospital-affiliated OTPs (sites 1, 3, and 5), and two were independent programs (sites 2 and 4). The OTP censuses ranged from 153 to 1007. All sites provided methadone maintenance therapy, and site 1 also provided buprenorphine maintenance therapy. Sites 1 and 5 had on-site HIV care available throughout the study, sites 2 and 3 had on-site HIV care available for part of the study period, and site 4 did not have on-site HIV-care PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/29072704 services.EligibilityResearch assistants, employed full-time at the sites and familiar with the OTP clients, were responsible for recruitment and initial screening of participants. We posted study flyers at all sites and made regular 4-Hydroxytamoxifen price presentations to counselors, intake specialists, and administrators to describe the purpose of th.
