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Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)

Primary Purpose

HIV, Substance Related Disorders

Status
Completed
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Methadone Maintenance Therapy
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bac Giang PAC OPC
  • Dong Da OPC
  • Hoang Mai HIV Clinic
  • Long Bien
  • Tu Liem
  • Thanh Hoa PAC OPC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buprenorphine/naloxone

Methadone Maintenance Therapy

Arm Description

Office based treatment of opioid dependence with buprenorphine/naloxone

Referral to methadone maintenance therapy for treatment of opioid dependence.

Outcomes

Primary Outcome Measures

Number of Participants With HIV Viral Suppression
HIV-1 RNA < 200 copies/mL
Participants With Heroin Use (Urine Drug Screen)
Participants With Heroin Use (Self-report)

Secondary Outcome Measures

Number of Participants in Receipt of Antiretroviral Therapy (ART)
Initiation of and retention on treatment with antiretroviral medications.
Number of Participants in Retention in HIV Care
HIV clinic visit in past 3 months

Full Information

First Posted
September 3, 2013
Last Updated
April 25, 2022
Sponsor
Oregon Health and Science University
Collaborators
Hanoi Medical University, Hennepin Healthcare Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01936857
Brief Title
Buprenorphine to Improve HIV Care Engagement and Outcomes
Acronym
BRAVO
Official Title
Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Hanoi Medical University, Hennepin Healthcare Research Institute

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Substance Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine/naloxone
Arm Type
Experimental
Arm Description
Office based treatment of opioid dependence with buprenorphine/naloxone
Arm Title
Methadone Maintenance Therapy
Arm Type
Active Comparator
Arm Description
Referral to methadone maintenance therapy for treatment of opioid dependence.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Other Intervention Name(s)
Suboxone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methadone Maintenance Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With HIV Viral Suppression
Description
HIV-1 RNA < 200 copies/mL
Time Frame
12 months
Title
Participants With Heroin Use (Urine Drug Screen)
Time Frame
12 months
Title
Participants With Heroin Use (Self-report)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants in Receipt of Antiretroviral Therapy (ART)
Description
Initiation of and retention on treatment with antiretroviral medications.
Time Frame
12 months
Title
Number of Participants in Retention in HIV Care
Description
HIV clinic visit in past 3 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip T Korthuis, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bac Giang PAC OPC
City
Bac Giang
Country
Vietnam
Facility Name
Dong Da OPC
City
Hanoi
Country
Vietnam
Facility Name
Hoang Mai HIV Clinic
City
Hanoi
Country
Vietnam
Facility Name
Long Bien
City
Hanoi
Country
Vietnam
Facility Name
Tu Liem
City
Hanoi
Country
Vietnam
Facility Name
Thanh Hoa PAC OPC
City
Thanh Hoa
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
34548042
Citation
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.
Results Reference
derived
PubMed Identifier
33539760
Citation
Korthuis 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. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.
Results Reference
derived

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Buprenorphine to Improve HIV Care Engagement and Outcomes

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