Integrating Buprenorphine Into HIV Treatment
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | September 2005 |
| End Date: | February 2009 |
| Contact: | Diana L Sylvestre, MD |
| Email: | dsylves@itsa.ucsf.edu |
| Phone: | 510-834-5442 |
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.
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.
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.
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.
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
We found this trial at
3
sites
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