Integrating Buprenorphine Into the SFGH AIDS Program

HIV Clinical Trial

— BHIVES-SF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263458
• Other study ID #: H97HA03799
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2005
• Last updated: September 8, 2011
• Start date: December 2005
• Est. completion date: June 2009

Study information

• Verified date: September 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Buprenorphine
• HIV
• Opioid Dependence
• Opioid-Related Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	UCSF Positive Health Program	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Health Resources and Services Administration (HRSA), San Francisco Department of Public Health, The New York Academy of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (11)

Altice FL, Bruce RD, Lucas GM, Lum PJ, Korthuis PT, Flanigan TP, Cunningham CO, Sullivan LE, Vergara-Rodriguez P, Fiellin DA, Cajina A, Botsko M, Nandi V, Gourevitch MN, Finkelstein R; BHIVES Collaborative. HIV treatment outcomes among HIV-infected, opioi — View Citation

Chaudhry AA, Botsko M, Weiss L, Egan JE, Mitty J, Estrada B, Lucas GM, Woodson T, Flanigan TP, Fiellin DA; BHIVES Collaborative. Participant characteristics and HIV risk behaviors among individuals entering integrated buprenorphine/naloxone and HIV care. — View Citation

Cheever LW, Kresina TF, Cajina A, Lubran R. A model federal collaborative to increase patient access to buprenorphine treatment in HIV primary care. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S3-6. doi: 10.1097/QAI.0b013e318209740f. — View Citation

Fiellin DA, Weiss L, Botsko M, Egan JE, Altice FL, Bazerman LB, Chaudhry A, Cunningham CO, Gourevitch MN, Lum PJ, Sullivan LE, Schottenfeld RS, O'Connor PG; BHIVES Collaborative. Drug treatment outcomes among HIV-infected opioid-dependent patients receivi — View Citation

Finkelstein R, Netherland J, Sylla L, Gourevitch MN, Cajina A, Cheever L; BHIVES Collaborative. Policy implications of integrating buprenorphine/naloxone treatment and HIV care. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S98-S104. doi: 10.1097/QAI — View Citation

Friedland G, Vlahov D. Integration of buprenorphine for substance-abuse treatment by HIV care providers. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S1-2. doi: 10.1097/QAI.0b013e31820bc9ba. — View Citation

Korthuis PT, Fiellin DA, Fu R, Lum PJ, Altice FL, Sohler N, Tozzi MJ, Asch SM, Botsko M, Fishl M, Flanigan TP, Boverman J, McCarty D; BHIVES Collaborative. Improving adherence to HIV quality of care indicators in persons with opioid dependence: the role o — View Citation

Sullivan LE, Botsko M, Cunningham CO, O'Connor PG, Hersh D, Mitty J, Lum PJ, Schottenfeld RS, Fiellin DA; BHIVES Collaborative. The impact of cocaine use on outcomes in HIV-infected patients receiving buprenorphine/naloxone. J Acquir Immune Defic Syndr. 2 — View Citation

Vergara-Rodriguez P, Tozzi MJ, Botsko M, Nandi V, Altice F, Egan JE, O'Connor PG, Sullivan LE, Fiellin DA; BHIVES Collaborative. Hepatic safety and lack of antiretroviral interactions with buprenorphine/naloxone in HIV-infected opioid-dependent patients. — View Citation

Weiss L, Egan JE, Botsko M, Netherland J, Fiellin DA, Finkelstein R. The BHIVES collaborative: organization and evaluation of a multisite demonstration of integrated buprenorphine/naloxone and HIV treatment. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Supp — View Citation

Weiss L, Netherland J, Egan JE, Flanigan TP, Fiellin DA, Finkelstein R, Altice FL; BHIVES Collaborative. Integration of buprenorphine/naloxone treatment into HIV clinical care: lessons from the BHIVES collaborative. J Acquir Immune Defic Syndr. 2011 Mar 1 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use outcomes at 0, 1, 3, 6, 9 and 12 months.		0, 1, 3, 6, 9 and 12 months.	No
Primary	HIV care outcomes at 0, 1, 3, 6, 9 and 12 months.		0, 1, 3, 6, 9 and 12 months	No
Secondary	HIV-related health		baseline, 1, 3, 6, 9 and 12 months	No
Secondary	Quality of life		0, 1, 3, 6, 9 and 12 months	No
Secondary	Social functioning		0, 1, 3, 6, 9 and 12 months	No
Secondary	Quality of HIV care.		0, 3, 6, 9 and 12 months	No
Secondary	Patient satisfaction at 3 months.		3 months	No

External Links

•   CSAT Buprenorphine
•   JAIDS. March 1, 2011 - Volume 56 - Supplement 1, Integration of Buprenorphine/Naloxone Treatment into HIV Clinical Care
•   The UCSF Positive Health Program at the University of California San Francisco