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

Yale University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Buprenorphine HIV Drug Abuse

Interventions

Services will be provided at one siteOTHER

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Substance use outcomes measured by self-report

Time frame: at 1, 3, 6, 9 and 12 months measured by self-report

Urine toxicology results

Time frame: at 1, 3, 6, 9 and 12 months

Retention in and adherence to HIV care

Time frame: at 1, 3, 6, 9 and 12 months

Secondary Outcomes

Quality of life

Time frame: at 1, 3, 6, 9, and 12 months

HIV-related health outcomes