- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00798538
Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM) (BELIEVE)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Yale AIDS Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Integrated
Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Substance use outcomes measured by self-report
Time Frame: at 1, 3, 6, 9 and 12 months measured by self-report
|
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
|
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
|
at 1, 3, 6, 9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: at 1, 3, 6, 9, and 12 months
|
at 1, 3, 6, 9, and 12 months
|
HIV-related health outcomes
Time Frame: at 1, 3, 6, 9, and 12 months
|
at 1, 3, 6, 9, and 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H97HA03800-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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