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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798538
First Posted: November 26, 2008
Last Update Posted: July 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Waterbury Hospital
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Information provided by (Responsible Party):
Yale University
  Purpose

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.


Condition Intervention Phase
Buprenorphine HIV Drug Abuse Drug Addiction Drug Dependence Drug Use Disorders Drug Use Disorder Substance Abuse Opiate Addiction Substance-related Disorders Other: Services will be provided at one site Other: Services remain dispersed; i.e., not centralized to one-location or provider. Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Quality of life [ Time Frame: at 1, 3, 6, 9, and 12 months ]
  • HIV-related health outcomes [ Time Frame: at 1, 3, 6, 9, and 12 months ]

Enrollment: 60
Study Start Date: August 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Integrated
Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.
Other: 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..
Placebo Comparator: 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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798538


Locations
United States, Connecticut
Yale AIDS Program
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Waterbury Hospital
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Investigators
Principal Investigator: Frederick Altice, MD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00798538     History of Changes
Other Study ID Numbers: H97HA03800-03
First Submitted: November 25, 2008
First Posted: November 26, 2008
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Yale University:
Buprenorphine
HIV
Drug Abuse
Drug Addiction
Drug Dependence
Drug Use Disorders
Drug Use Disorder
Substance Abuse
Opiate Addiction
Substance-related disorders

Additional relevant MeSH terms:
Disease
Behavior, Addictive
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists