PROTOCOL NIDA-CTN-0067


Comparing Treatments for HIV-Positive Opioid Users in an Integrated Care Effectiveness Study (CHOICES): Scale-Up

[study in development; more information coming soon]

This study builds on lessons learned from the CHOICES pilot study (CTN-0055) and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care settings. Ten HIV primary care clinics will be selected to participate in this open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) (n=200) versus TAU (n=200) in HIV-infected participants with untreated opioid or alcohol use disorders. A follow-up visit at 48 weeks assesses participant safety (e.g. overdose) and continuation on XR-NTX after the 24 weeks of study drug exposure. Co-primary outcomes are 1) number of days of illicit opioid use or heavy drinking in the past 30 days (Aim 1), and 2) HIV viral suppression (HIV-1 RNA < 200 copies/mL) at 24 weeks (Aim 2). Secondary outcomes include CD4 count, HIV care engagement, risk behaviors and quality of life at 24 weeks, as well as sustained HIV viral suppression, overdose, return to substance use (TLFB, ASI-lite), and XR-NTX treatment continuation at 48 weeks.

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Publications about CTN-0067 (if available)

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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