Buprenorphine to Improve HIV Care Engagement and Outcomes

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV, Substance Related Disorders

Intervention / Treatment
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* Drug: Buprenorphine/naloxone
* Drug: Methadone Maintenance Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine/naloxone<br>Office based treatment of opioid dependence with buprenorphine/naloxone | Drug: Buprenorphine/naloxone<br>* 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.<br>* Other names: Suboxone;|
| Active Comparator: Methadone Maintenance Therapy<br>Referral to methadone maintenance therapy for treatment of opioid dependence. | Drug: Methadone Maintenance Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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