Buprenorphine to Improve HIV Care Engagement and Outcomes

Phase 4

Completed

• Conditions: HIV; Substance Related Disorders
• Interventions: Drug: Buprenorphine/naloxone; Drug: Methadone Maintenance Therapy

• Registration Number: NCT01936857
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-06
• Study Start: 2015-07
• Primary Completion: 2019-03
• Study Completion: 2019-04
• Results First Submitted: 2020-06-05
• Results First Submitted QC: 2020-06-05
• Results First Posted: 2020-06-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine/naloxone	Buprenorphine/naloxone	Office based treatment of opioid dependence with buprenorphine/naloxone
Methadone Maintenance Therapy	Methadone Maintenance Therapy	Referral to methadone maintenance therapy for treatment of opioid dependence.

Primary Outcome Measures

Name	Time	Method
Number of Participants With HIV Viral Suppression	12 months	HIV-1 RNA \< 200 copies/mL
Participants With Heroin Use (Urine Drug Screen)	12 months
Participants With Heroin Use (Self-report)	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Hoang Mai HIV Clinic; 🇻🇳 Hanoi, Vietnam

Dong Da OPC; 🇻🇳 Hanoi, Vietnam

Thanh Hoa PAC OPC; 🇻🇳 Thanh Hoa, Vietnam

Long Bien; 🇻🇳 Hanoi, Vietnam

Tu Liem; 🇻🇳 Hanoi, Vietnam

Bac Giang PAC OPC; 🇻🇳 Bac Giang, Vietnam