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Integrating Buprenorphine Into the SFGH AIDS Program

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00263458
Acronym
BHIVES-SF
Enrollment
37
Registered
2005-12-08
Start date
2005-12-31
Completion date
2009-06-30
Last updated
2011-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Buprenorphine, HIV, Opioid Dependence

Keywords

HIV, acquired immunodeficiency syndrome, buprenorphine, opioid dependence, opioid-related disorders, integrated care, primary care

Brief summary

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.

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.

Interventions

OTHERIntegrated 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).

Sponsors

San Francisco Department of Public Health
CollaboratorOTHER_GOV
The New York Academy of Medicine
CollaboratorOTHER
Health Resources and Services Administration (HRSA)
CollaboratorFED
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Substance use outcomes at 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.0, 1, 3, 6, 9 and 12 months

Secondary

MeasureTime frame
Social functioning0, 1, 3, 6, 9 and 12 months
HIV-related healthbaseline, 1, 3, 6, 9 and 12 months
Patient satisfaction at 3 months.3 months
Quality of HIV care.0, 3, 6, 9 and 12 months
Quality of life0, 1, 3, 6, 9 and 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026