Integrating Buprenorphine Into HIV Treatment

SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model

We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes as well as drug treatment outcomes in heroin users. This study will test this hypothesis by randomizing patients to two groups. The first group will receive HIV treatment and buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine treatment services.

We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at appointments and drug treatment outcomes such as receipt of buprenorphine and urine toxicology testing.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; Opiate Dependence
• Intervention / Treatment: Behavioral: Integrating drug treatment into HIV services

Detailed Description

This study will test the hypothesis that integrating buprenorphine within the context of primary care HIV treatment will improve outcomes for HIV-infected heroin users vs providing buprenorphine services at a separate, off-site facility. As a means of engagement, we will offer the OASIS education group each week at each facility. For those randomized to integrated care, subjects will attend one education session weekly at the time of their HIV clinic. During these sessions, subjects will receive contemporaneous HIV clinic appointments (monthly), case management (monthly), drug counseling (twice monthly), and buprenorphine (which will be dispensed weekly.) For those randomized to separate care, subjects will attend HIV clinic appointments monthly, and will attend weekly education sessions at the OASIS facility. During these sessions, subjects will receive weekly buprenorphine, twice monthly drug counseling, and monthly case management.

We will measure outcomes by reporting attendance, CD4 counts, HIV viral loads, urine toxicology testing on at least a quarterly basis. We will also measure patient satisfaction, knowledge, quality of life, and a number of other outcomes.

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94602
      • Recruiting
      • Alameda County Medical Center HIV Clinic
      • Contact: Lance Smith; Phone Number: 510-437-4888
      • Contact: Silver Sisneros, MD; Phone Number: 510-437-4891; Email: ssisneros@acmedctr.org
      • Principal Investigator: Silver Sisneros, DO
    • Oakland, California, United States, 94612
      • Recruiting
      • Oasis
      • Contact: Laphyne Barrett; Phone Number: 510-834-5442; Email: oasisclinic@sbcglobal.net
      • Principal Investigator: Diana L Sylvestre, MD
    • San Leandro, California, United States, 94578
      • Recruiting
      • Fairmont Hospital HIV Clinic
      • Contact: Lance Smith; Phone Number: 510-437-4888
      • Contact: Beth Schweitzer, MD; Phone Number: 510-667-3201
      • Principal Investigator: Beth Schweitzer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV+ as verified by lab report
• DSM-IV diagnosis of opioid dependence
• Speaks/understands English
• Age 18 years or older

Exclusion Criteria:

• LFT's (transaminase) >5x ULN
• DSV-IV criteria for benzodiazepine abuse or dependence within the last month
• DSM-IV criteria for alcohol dependence within the past 6 months
• Actively suicidal
• Methadone dose exceeds level allowing safe transition to buprenorphine
• Pregnant women and women trying to become pregnant
• Unable to provide informed consent
• Clinical judgement that patient is inappropriate

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1.Impact of integrated care vs nonintegrated care on:
a. Substance use and high-risk transmission behaviors
b. Medical engagement and outcomes
c. Psychosocial indices, such as criminal justice, employment, housing, and education

Secondary Outcome Measures

Outcome Measure
1. Acceptability of HIV treatment-based buprenorphine therapy
2. Health services utilization

Collaborators and Investigators

• Sponsor: Organization to Achieve Solutions in Substance Abuse (OASIS)
• Investigators: Principal Investigator: Diana L Sylvestre, MD, Organization to Achieve Solutions in Substance Abuse (OASIS); Study Director: Ruth Finkelstein, ScD, New York Academy of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion: February 1, 2009

Study Registration Dates

• First Submitted: October 17, 2005
• First Submitted That Met QC Criteria: October 17, 2005
• First Posted (Estimate): October 19, 2005

Study Record Updates

• Last Update Posted (Estimate): October 25, 2005
• Last Update Submitted That Met QC Criteria: October 24, 2005
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Keywords: buprenorphine; HIV; Heroin; drug treatment; integration
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: H97HA03792; 1 H97HA03792-01-00