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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Waterbury Hospital
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00798538
First received: November 25, 2008
Last updated: June 30, 2010
Last verified: June 2010
History of Changes

November 25, 2008
June 30, 2010
August 2005
August 2010   (final data collection date for primary outcome measure)
  • Substance use outcomes measured by self-report [ Time Frame: at 1, 3, 6, 9 and 12 months measured by self-report ] [ Designated as safety issue: No ]
  • Urine toxicology results [ Time Frame: at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Retention in and adherence to HIV care [ Time Frame: at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Substance use outcomes measured by self-report [ Time Frame: at 1, 3 and 6 months measured by self-report ] [ Designated as safety issue: No ]
  • Urine toxicology results [ Time Frame: at 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Retention in and adherence to HIV care [ Time Frame: at 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00798538 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: at 1, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • HIV-related health outcomes [ Time Frame: at 1, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)
Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • 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
    Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..
  • 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.
  • Active Comparator: Integrated
    Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.
    Intervention: Other: Services will be provided at one site
  • 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.
    Intervention: Other: Services remain dispersed; i.e., not centralized to one-location or provider.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00798538
H97HA03800-03
No
Frederick Altice, MD, Yale University School of Medicine
Yale University
  • Waterbury Hospital
  • Health Resources and Services Administration (HRSA)
  • The New York Academy of Medicine
Principal Investigator: Frederick Altice, MD Yale University
Yale University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP