Integration of Buprenorphine Into HIV Clinical Settings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Buprenorphine HIV Drug Abuse Drug Addiction Drug Dependence Drug Use Disorders Drug Use Disorder Substance Abuse Opiate Addiction Substance-related Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Integrated

Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.

Group Type ACTIVE_COMPARATOR

Services will be provided at one site

Intervention Type OTHER

Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..

Non-integrated

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.

Group Type PLACEBO_COMPARATOR

Services remain dispersed; i.e., not centralized to one-location or provider.

Intervention Type OTHER

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.

Interventions

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Services will be provided at one site

Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..

Intervention Type OTHER

Services remain dispersed; i.e., not centralized to one-location or provider.

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No