Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)

April 25, 2022 updated by: P. Todd Korthuis, MD, Oregon Health and Science University

Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Buprenorphine/naloxone
Office based treatment of opioid dependence with buprenorphine/naloxone
Drug: Buprenorphine/naloxone
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.
Other Names:
  • Suboxone
ACTIVE_COMPARATOR: Methadone Maintenance Therapy
Referral to methadone maintenance therapy for treatment of opioid dependence.
Drug: Methadone Maintenance Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With HIV Viral Suppression
Time Frame: 12 months
HIV-1 RNA < 200 copies/mL
12 months
Participants With Heroin Use (Urine Drug Screen)
Time Frame: 12 months
12 months
Participants With Heroin Use (Self-report)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in Receipt of Antiretroviral Therapy (ART)
Time Frame: 12 months
Initiation of and retention on treatment with antiretroviral medications.
12 months
Number of Participants in Retention in HIV Care
Time Frame: 12 months
HIV clinic visit in past 3 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Hanoi Medical University
Hennepin Healthcare Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (ESTIMATE)

September 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA037441_VNE
  • 1R01DA037441 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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