Naltrexone for Extended-Release Injectable Suspension (XR-NTX) for Opioid Dependent Released HIV-Positive Criminal Justice Populations (Project NEW HOPE), Connecticut and Massachusetts, 2011-2015 (ICPSR 39790)
Version Date: Apr 21, 2026 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
Sandra A. Springer, Yale University;
Frederick Altice, Yale University;
Thomas Lincoln, Baystate Medical Center;
Daniel J. Skiest, Baystate Medical Center
Series:
https://doi.org/10.3886/ICPSR39790.v1
Version V1
Summary View help for Summary
This study is part of the Seek, Test, Treat and Retain (STTR) Collaboration Project that involved over twenty studies in the fields of HIV and drug abuse. All studies were independently developed, but were chosen for the collaboration because they focused on one or more steps of the HIV treatment cascade: Seek, Test, Treat and Retain. As part of STTR Collaboration Project, the studies were grouped into Criminal Justice-related studies and Vulnerable Population-related studies. The data collected by these studies included twelve common domains (e.g., Demographic characteristics, Mental Health) in each of which a shared questionnaire or instrument was taken up by the studies and adapted to fit the study.
The specific aim for this study was to conduct a placebo-controlled, RCT of VIVITROL or (extended-release naltrexone) (XR-NTX 380mg) among HIV+ persons in jails and prisons meeting DSM-IV criteria for opioid dependence who are transitioning to the community. HIV treatment outcomes (HIV-1 RNA levels, CD4 count, HAART adherence, retention in care), substance abuse (time to relapse to opioid use, % opioid negative urines, opioid craving), adverse side effects and HIV risk behavior (sexual and drug-related risks) outcomes were compared in 150 recruited prisoners and jail detainees in CT and MA who were randomized 2:1 to either XR-NTX 380mg or XR-NTX-placebo. The primary outcome of interest was the proportion with a HIV-RNA less than 400 copies/mL at 6 months. Secondary outcomes included mean CD4 count, antiretroviral adherence, retention on HAART and in HIV care, HIV risk behaviors, time-to-relapse to opioid use, percent opioid negative urines, retention on XR-NTX 380mg and HIV quality of life. Primary and secondary outcomes were assessed for an additional 6 months after completion of the intervention.
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This release is a Fast Track Release. Users should consult the investigator(s) if further information is needed.
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This study includes baseline and longitudinal data files, study summary, and study data documentation.
Study Purpose View help for Study Purpose
The specific aim for this study was to conduct a placebo-controlled, RCT of VIVITROL or (extended-release naltrexone) (XR-NTX 380mg) among HIV+ persons in jails and prisons who met DSM-IV criteria for opioid dependence and who were transitioning to the community.
Study Design View help for Study Design
The study was a randomized, placebo-controlled trial. Intervention was at 6 months with 6 months follow=up post-intervention.
The randomization method was covariate adaptive randomization. Covariates included in the randomization included: 1) city of return (New Haven vs. Hartford vs. Waterbury vs. Springfield); 2) being prescribed or not prescribed antiretroviral therapy. Randomization is 2:1 to XR-NTX 380mg: XR-NTX placebo.
Sample View help for Sample
Recruitment was from 20 correctional facilities within the CTDOC or HCCC. Potential participants were 30 days pre-release or 30 days post-release
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Universe View help for Universe
HIV positive and opioid dependent adults at 20 correctional facilities within the CTDOC or HCCC who were 30 days pre-release or 30 days post-release.
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