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Completed

NCT Number: NCT01936857

Buprenorphine to Improve HIV Care Engagement and Outcomes

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.

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Key information

Conditions

HIV Chemically-Induced Disorders Mental Disorders Substance Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bac Giang PAC OPC, Bắc Giang, Vietnam

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine/naloxone

Drug

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

Methadone Maintenance Therapy

Drug

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 outcomes

  1. Number of Participants With HIV Viral Suppression

    Time frame: 12 months

    HIV-1 RNA < 200 copies/mL

  2. Participants With Heroin Use (Urine Drug Screen)

    Time frame: 12 months

  3. Participants With Heroin Use (Self-report)

    Time frame: 12 months

Secondary outcomes

  1. Number of Participants in Receipt of Antiretroviral Therapy (ART)

    Time frame: 12 months

    Initiation of and retention on treatment with antiretroviral medications.

  2. Number of Participants in Retention in HIV Care

    Time frame: 12 months

    HIV clinic visit in past 3 months

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Hanoi Medical University
  • Hennepin Healthcare Research Institute

Registry information

Official study title

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

Acronym: BRAVO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2013
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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