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

September 8, 2011 updated by: University of California, San Francisco

Integrating Buprenorphine Into the SFGH AIDS Program (Patient Evaluation Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • UCSF Positive Health Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Suboxone, Subutex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Substance use outcomes at 0, 1, 3, 6, 9 and 12 months.
Time Frame: 0, 1, 3, 6, 9 and 12 months.
0, 1, 3, 6, 9 and 12 months.
HIV care outcomes at 0, 1, 3, 6, 9 and 12 months.
Time Frame: 0, 1, 3, 6, 9 and 12 months
0, 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV-related health
Time Frame: baseline, 1, 3, 6, 9 and 12 months
baseline, 1, 3, 6, 9 and 12 months
Quality of life
Time Frame: 0, 1, 3, 6, 9 and 12 months
0, 1, 3, 6, 9 and 12 months
Social functioning
Time Frame: 0, 1, 3, 6, 9 and 12 months
0, 1, 3, 6, 9 and 12 months
Quality of HIV care.
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Patient satisfaction at 3 months.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
San Francisco Department of Public Health

Investigators

  • Principal Investigator: Paula J Lum, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 8, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 8, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H97HA03799

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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