HIV Infections Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Alameda County Medical Center HIV Clinic | Oakland | California |
United States | OASIS | Oakland | California |
United States | Fairmont Hospital HIV Clinic | San Leandro | California |
Lead Sponsor | Collaborator |
---|---|
Organization to Achieve Solutions in Substance Abuse (OASIS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1.Impact of integrated care vs nonintegrated care on: | |||
Primary | a. Substance use and high-risk transmission behaviors | |||
Primary | b. Medical engagement and outcomes | |||
Primary | c. Psychosocial indices, such as criminal justice, employment, housing, and education | |||
Secondary | 1. Acceptability of HIV treatment-based buprenorphine therapy | |||
Secondary | 2. Health services utilization |
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