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
Recruitment status was Active, not recruiting
Sponsor:
Yale University
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
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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: 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 ] [ 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 60 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | August 2010 |
| Estimated 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Frederick Altice, MD, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00798538 History of Changes |
| Other Study ID Numbers: | H97HA03800-03 |
| Study First Received: | November 25, 2008 |
| Last Updated: | June 30, 2010 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Substance-Related Disorders Behavior, Addictive Opioid-Related Disorders Mental Disorders Compulsive Behavior Impulsive Behavior Buprenorphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on June 17, 2013