Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1350 participants
INTERVENTIONAL
2005-08-31
2008-12-31
Brief Summary
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Detailed Description
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Through this study, approximately 1,350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the U.S. Information on patients' drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers' practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews, audio computer-assisted self-interviewing, written surveys, and chart abstractions. These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals.
Comparisons: All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention. However, the program designs and comparison group interventions vary across the sites and are locally determined. Some sites will implement randomized control designs, while others will use observational methods.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Buprenorphine
Integrated HIV care and office-based opioid dependence treatment
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of opioid dependence
* Fluent in English or Spanish
* 18 years or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Health Resources and Services Administration (HRSA)
FED
El Rio Santa Cruz Neighborhood Health Center
UNKNOWN
Organization to Achieve Solutions in Substance Abuse (OASIS)
OTHER
Oregon Health and Science University
OTHER
Montefiore Medical Center
OTHER
University of Miami
OTHER
Brown University
OTHER
University of California, San Francisco
OTHER
Johns Hopkins University
OTHER
CORE Center, Cook County Bureau of Health Services
UNKNOWN
Yale University
OTHER
The New York Academy of Medicine
OTHER
Principal Investigators
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Ruth Finkelstein, ScD
Role: PRINCIPAL_INVESTIGATOR
New York Academy of Medicine
David Fiellin, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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El Rio Santa Cruz Neighborhood Health Center
Tucson, Arizona, United States
Organization to Achieve Solutions in Substance Abuse
Oakland, California, United States
University of California San Francisco
San Francisco, California, United States
Yale University School of Medicine AIDS Program
New Haven, Connecticut, United States
University of Miami School of Medicine
Miami, Florida, United States
The CORE Center
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Montefiore Medical Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
The Miriam Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Jeff Thomas, ACSW
Role: primary
Laphyne Barrett, MA
Role: primary
Bob Thawley
Role: primary
Declan Barry, PhD
Role: primary
Leslie Thompson, RN, BSN
Role: primary
Mary Jo Tozzi
Role: primary
Greg Lucas, MD, PhD
Role: primary
Galit Sacajiu, MD
Role: primary
Catherine Pedersen, MPA
Role: primary
Helen Loewenthal, MSW
Role: primary
Other Identifiers
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H97HA03795
Identifier Type: -
Identifier Source: secondary_id
063005
Identifier Type: -
Identifier Source: org_study_id