Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

Phase 4

Completed

• Conditions: Opiate Addiction; Buprenorphine; HIV; Drug Dependence; Substance Abuse; Substance-related Disorders; Drug Abuse; Drug Addiction; Drug Use Disorders; Drug Use Disorder
• Interventions: Other: Services remain dispersed; i.e., not centralized to one-location or provider.; Other: Services will be provided at one site

• Registration Number: NCT00798538
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.

In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.

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 Start: 2005-08
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• HIV-infected
• Clinical diagnosis of opioid dependence
• Fluent in English or Spanish
• 18 years or older

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Exclusion Criteria

• Liver function tests (transaminase only) at five times or higher than normal level;
• Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
• DSM-IV criteria for alcohol dependence within the past 6 months;
• Actively suicidal;
• Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
• Methadone dose exceeding levels allowing for safe transition to buprenorphine;
• Pregnant women and women actively trying to become pregnant;
• Clinical judgment of local site principal investigator that patient is inappropriate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-integrated	Services remain dispersed; i.e., not centralized to one-location or provider.	Buprenorphine induction, substance abuse counseling and HIV care will be managed at multiple locations, respectively: the Community Health Care Van, the Yale AIDS Program, and individuals' HIV clinics.
Integrated	Services will be provided at one site	Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.

Primary Outcome Measures

Name	Time	Method
Substance use outcomes measured by self-report	at 1, 3, 6, 9 and 12 months measured by self-report
Retention in and adherence to HIV care	at 1, 3, 6, 9 and 12 months
Urine toxicology results	at 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	at 1, 3, 6, 9, and 12 months
HIV-related health outcomes	at 1, 3, 6, 9, and 12 months

Trial Locations

Locations (1)

Yale AIDS Program; 🇺🇸 New Haven, Connecticut, United States