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

Primary Purpose

Buprenorphine, HIV, Drug Abuse

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Services will be provided at one site
Services remain dispersed; i.e., not centralized to one-location or provider.
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Buprenorphine focused on measuring Buprenorphine, HIV, Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Opiate Addiction, Substance-related disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yale AIDS Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Integrated

Non-integrated

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Substance use outcomes measured by self-report
Urine toxicology results
Retention in and adherence to HIV care

Secondary Outcome Measures

Quality of life
HIV-related health outcomes

Full Information

First Posted
November 25, 2008
Last Updated
July 23, 2015
Sponsor
Yale University
Collaborators
Waterbury Hospital, Health Resources and Services Administration (HRSA), The New York Academy of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00798538
Brief Title
Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)
Acronym
BELIEVE
Official Title
Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Waterbury Hospital, Health Resources and Services Administration (HRSA), The New York Academy of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Buprenorphine, HIV, Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Opiate Addiction, Substance-related Disorders
Keywords
Buprenorphine, HIV, Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Opiate Addiction, Substance-related disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated
Arm Type
Active Comparator
Arm Description
Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.
Arm Title
Non-integrated
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Services will be provided at one site
Intervention Description
Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..
Intervention Type
Other
Intervention Name(s)
Services remain dispersed; i.e., not centralized to one-location or provider.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Substance use outcomes measured by self-report
Time Frame
at 1, 3, 6, 9 and 12 months measured by self-report
Title
Urine toxicology results
Time Frame
at 1, 3, 6, 9 and 12 months
Title
Retention in and adherence to HIV care
Time Frame
at 1, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
at 1, 3, 6, 9, and 12 months
Title
HIV-related health outcomes
Time Frame
at 1, 3, 6, 9, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Altice, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale AIDS Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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

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