Clinical trial NCT00124358: Buprenorphine and Integrated HIV Care Evaluation
Official title: An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Opioid-Related Disorders
HIV Infections
AIDS
Keywords: Drug Abuse
Drug Addiction
Drug Dependence
Drug Use Disorders
Drug Use Disorder
Substance Abuse
Substance Use Disorder
Buprenorphine
Opiate Addiction
Substance-related disorders
HIV
Lead sponsor: The New York Academy of Medicine
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: El Rio Santa Cruz Neighborhood Health Center
name: Organization to Achieve Solutions in Substance Abuse (OASIS)
name: Oregon Health and Science University
name: Montefiore Medical Center
name: University of Miami
name: Brown University
name: University of California, San Francisco
name: Johns Hopkins University
name: CORE Center, Cook County Bureau of Health Services
name: Yale University
First posted: 2005-07-27
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV (with its complex medical needs) and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of PLWH/A, or their broader impact on providers, institutions, and local systems.

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.

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

Primary outcomes:
measure: Substance use outcomes at 1, 3 and 6 months measured by self-report
measure: Urine toxicology results at 1, 3, 6, and 12 months
measure: Retention in and adherence to HIV care at 1, 3, 6, and 12 months
Secondary outcomes:
measure: Quality of life at 1, 3, 6, 9, and 12 months
measure: HIV-related health outcomes at 1, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: El Rio Santa Cruz Neighborhood Health Center
state: Arizona
city: Oakland
country: United States
facility: Organization to Achieve Solutions in Substance Abuse
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine AIDS Program
state: Connecticut
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: The CORE Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: New York Academy of Medicine
name: Ruth Finkelstein, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: David Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References: