Integrating Buprenorphine Into the SFGH AIDS Program (BHIVES-SF)

This study has been completed.
Sponsor:
Collaborators:
San Francisco Department of Public Health
The New York Academy of Medicine
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00263458
First received: December 6, 2005
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to assess the feasibility, cost, and effectiveness of a model of care designed to integrate buprenorphine treatment for opioid dependence into the HIV primary care clinics at the UCSF Positive Health Program.


Condition Intervention Phase
HIV
Buprenorphine
Opioid Dependence
Other: Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrating Buprenorphine Into the SFGH AIDS Program (Patient Evaluation Study)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Substance use outcomes at 0, 1, 3, 6, 9 and 12 months. [ Time Frame: 0, 1, 3, 6, 9 and 12 months. ] [ Designated as safety issue: No ]
  • HIV care outcomes at 0, 1, 3, 6, 9 and 12 months. [ Time Frame: 0, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV-related health [ Time Frame: baseline, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 0, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Social functioning [ Time Frame: 0, 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Quality of HIV care. [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: December 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated
Buprenorphine maintenance treatment delivered at an HIV primary care clinic
Other: Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting
Eligible opioid-dependent HIV-infected patients are randomly assigned to receive buprenorphine opioid agonist treatment for 12 months either in an integrated HIV primary care setting (intervention group) versus a non-integrated substance use treatment clinic setting (comparison group).
Other Name: Suboxone, Subutex
Active Comparator: Non-integrated
Buprenorphine maintenance treatment delivered at a public health substance use disorder clinic
Other: Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting
Eligible opioid-dependent HIV-infected patients are randomly assigned to receive buprenorphine opioid agonist treatment for 12 months either in an integrated HIV primary care setting (intervention group) versus a non-integrated substance use treatment clinic setting (comparison group).
Other Name: Suboxone, Subutex

Detailed Description:

The UCSF Positive Health Program (formerly called the AIDS Program) at San Francisco General Hospital (SFGH) is one of the oldest and largest HIV/AIDS clinics in the United States. Located at the public hospital serving medically indigent residents of San Francisco, the Positive Health Program (PHP) provides over 2,000 patient visits per month to 2,300 patients in a comprehensive HIV primary care setting. The clinic population is disproportionately affected by heroin and other opiate abuse problems. Opiate replacement therapy (ORT) has a stabilizing effect in HIV-infected injecting drug users (IDU) and is associated with greater acceptance of antiretroviral (ARV) therapy, higher ARV adherence, and greater engagement in appropriate HIV-related health care. However, there are insufficient resources to meet the critical substance abuse treatment needs among our opioid-dependent patients.

In partnership with the Community Behavioral Health Services (CBHS) section of the San Francisco Department of Public Health (SFDPH), the UCSF Positive Health Program (PHP) at San Francisco General Hospital (SFGH) has developed a model of care, which provides opioid-dependent patients with integrated, office-based buprenorphine ORT in the HIV primary care setting. The program also offers primary care providers with education and training on addiction, opiate addiction treatment, and the appropriate use of buprenorphine. An evaluation of the program is planned to examine: (1) its effects on the health and substance use of patients; (2) program costs; and (3) what broader impact the program has on providers, institutions, and local systems. In the patient evaluation study, eligible, opioid-dependent patients that receive primary HIV care at the PHP will be randomly assigned to receive buprenorphine ORT for twelve months either in the integrated HIV primary care setting (intervention group) versus a non-integrated substance abuse treatment clinic setting (comparison group). Data will be abstracted from medical chart reviews and will be collected from patients using standardized instruments and satisfaction surveys.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Fluent in English
  • Receive HIV primary care at the UCSF Positive Health Program
  • Meet DSM-IVR criteria for opioid dependence
  • Meet clinical criteria for buprenorphine treatment (see Exclusion Criteria)
  • Plan to stay in the San Francisco Bay Area for the next 12 months

Exclusion Criteria:

  • Severe hepatic dysfunction, i.e., AST and/or ALT > 5X upper limit of normal
  • 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 or opiate analgesic doses exceed level allowing for safe transition to buprenorphine
  • Pregnant women and women actively trying to become pregnant

Potential subjects also will be excluded for:

  • Any medical condition(s), which, in the opinion of the investigator, would interfere with the patient's ability to participate in or adhere to the requirements of this study
  • Unable or who decline to provide informed consent for the evaluation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263458

Locations
United States, California
UCSF Positive Health Program
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
San Francisco Department of Public Health
The New York Academy of Medicine
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Paula J Lum, MD, MPH University of California, San Francisco
  More Information

Additional Information:
Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00263458     History of Changes
Other Study ID Numbers: H97HA03799
Study First Received: December 6, 2005
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
acquired immunodeficiency syndrome
buprenorphine
opioid dependence
opioid-related disorders
integrated care
primary care

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
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 April 17, 2014