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

Information source: Yale University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Buprenorphine; HIV; Drug Abuse; Drug Addiction; Drug Dependence; Drug Use Disorders; Drug Use Disorder; Substance Abuse; Opiate Addiction; Substance-related Disorders

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

Phase: Phase 4

Status: Completed

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Frederick Altice, MD, Principal Investigator, Affiliation: Yale University


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Substance use outcomes measured by self-report

Urine toxicology results

Retention in and adherence to HIV care

Secondary outcome:

Quality of life

HIV-related health outcomes


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Yale AIDS Program, New Haven, Connecticut 06510, United States
Additional Information

Starting date: August 2005
Last updated: July 23, 2015

Page last updated: August 20, 2015

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