Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)
Overview
- Phase
- Phase 4
- Intervention
- Buprenorphine/naloxone
- Conditions
- HIV
- Sponsor
- Oregon Health and Science University
- Enrollment
- 281
- Locations
- 6
- Primary Endpoint
- Number of Participants With HIV Viral Suppression
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.
Investigators
P. Todd Korthuis, MD
Professor of Medicine
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- •HIV positive
- •Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder
- •Urine drug screen positive for opioids
- •Interested in receiving treatment for opioid dependence
- •Age at least 18 years old
- •Willing to practice an effective method of birth control, if female
Exclusion Criteria
- •Known hypersensitivity to buprenorphine or naloxone
- •aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) \> 5x upper limit
- •Currently pregnant or breastfeeding
- •Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician
- •Methadone maintenance treatment within 30 days of consent
Arms & Interventions
Buprenorphine/naloxone
Office based treatment of opioid dependence with buprenorphine/naloxone
Intervention: Buprenorphine/naloxone
Methadone Maintenance Therapy
Referral to methadone maintenance therapy for treatment of opioid dependence.
Intervention: Methadone Maintenance Therapy
Outcomes
Primary Outcomes
Number of Participants With HIV Viral Suppression
Time Frame: 12 months
HIV-1 RNA \< 200 copies/mL
Participants With Heroin Use (Urine Drug Screen)
Time Frame: 12 months
Participants With Heroin Use (Self-report)
Time Frame: 12 months
Secondary Outcomes
- Number of Participants in Receipt of Antiretroviral Therapy (ART)(12 months)
- Number of Participants in Retention in HIV Care(12 months)