Integrating Buprenorphine Into HIV Treatment
Recruitment status was: Recruiting
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.
Behavioral: Integrating drug treatment into HIV services
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model|
- 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
- 1. Acceptability of HIV treatment-based buprenorphine therapy
- 2. Health services utilization
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||February 2009|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241930
|United States, California|
|Alameda County Medical Center HIV Clinic|
|Oakland, California, United States, 94602|
|Oakland, California, United States, 94612|
|Fairmont Hospital HIV Clinic|
|San Leandro, California, United States, 94578|
|Principal Investigator:||Diana L Sylvestre, MD||Organization to Achieve Solutions in Substance Abuse (OASIS)|
|Study Director:||Ruth Finkelstein, ScD||New York Academy of Medicine|