Integrating Buprenorphine Into the SFGH AIDS Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Buprenorphine, Opioid Dependence

Intervention / Treatment
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* Other: Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated<br>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<br>* 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).<br>* Other names: Suboxone, Subutex;|
| Active Comparator: Non-integrated<br>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<br>* 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).<br>* Other names: Suboxone, Subutex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, acquired immunodeficiency syndrome, buprenorphine, opioid dependence, opioid-related disorders, integrated care, primary care