Buprenorphine to Improve HIV Care Engagement and Outcomes
BRAVO
2 other identifiers
interventional
281
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv
Started Jul 2015
Longer than P75 for phase_4 hiv
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2013
CompletedFirst Posted
Study publicly available on registry
September 6, 2013
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedResults Posted
Study results publicly available
June 24, 2020
CompletedMay 17, 2022
April 1, 2022
3.7 years
September 3, 2013
June 5, 2020
April 25, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With HIV Viral Suppression
HIV-1 RNA \< 200 copies/mL
12 months
Participants With Heroin Use (Urine Drug Screen)
12 months
Participants With Heroin Use (Self-report)
12 months
Secondary Outcomes (2)
Number of Participants in Receipt of Antiretroviral Therapy (ART)
12 months
Number of Participants in Retention in HIV Care
12 months
Study Arms (2)
Buprenorphine/naloxone
EXPERIMENTALOffice based treatment of opioid dependence with buprenorphine/naloxone
Methadone Maintenance Therapy
ACTIVE COMPARATORReferral to methadone maintenance therapy for treatment of opioid dependence.
Interventions
Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Hanoi Medical Universitycollaborator
- Hennepin Healthcare Research Institutecollaborator
Study Sites (6)
Bac Giang PAC OPC
Bắc Giang, Vietnam
Dong Da OPC
Hanoi, Vietnam
Hoang Mai HIV Clinic
Hanoi, Vietnam
Long Bien
Hanoi, Vietnam
Tu Liem
Hanoi, Vietnam
Thanh Hoa PAC OPC
Thanh Hóa, Vietnam
Related Publications (2)
Edsall A, Hoffman KA, Thuy DT, Mai PP, Hang NT, Khuyen TT, Trang NT, Kunkel LE, Giang LM, Korthuis PT. Use of methamphetamine and alcohol among people with opioid use disorder and HIV in Vietnam: a qualitative study. BMC Public Health. 2021 Sep 22;21(1):1718. doi: 10.1186/s12889-021-11783-9.
PMID: 34548042DERIVEDKorthuis PT, King C, Cook RR, Khuyen TT, Kunkel LE, Bart G, Nguyen T, Thuy DT, Bielavitz S, Nguyen DB, Tam NTM, Giang LM. HIV clinic-based buprenorphine plus naloxone versus referral for methadone maintenance therapy for treatment of opioid use disorder in HIV clinics in Vietnam (BRAVO): an open-label, randomised, non-inferiority trial. Lancet HIV. 2021 Feb;8(2):e67-e76. doi: 10.1016/S2352-3018(20)30302-7.
PMID: 33539760DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Todd Korthuis
- Organization
- Oregon Health & Science University
Study Officials
- PRINCIPAL INVESTIGATOR
Philip T Korthuis, MD, MPH
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
September 3, 2013
First Posted
September 6, 2013
Study Start
July 1, 2015
Primary Completion
March 1, 2019
Study Completion
April 1, 2019
Last Updated
May 17, 2022
Results First Posted
June 24, 2020
Record last verified: 2022-04