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

Yale University

Status and phase: Completed; Phase 4

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

Treatments: Other: Services will be provided at one site; Other: Services remain dispersed; i.e., not centralized to one-location or provider.

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00798538

H97HA03800-03

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Integrated

Active Comparator group

Description:

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

Treatment:

Other: Services will be provided at one site

Non-integrated

Placebo Comparator group

Description:

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.

Treatment:

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