Integrating Buprenorphine Into HIV Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00241930|
Recruitment Status : Unknown
Verified August 2005 by Organization to Achieve Solutions in Substance Abuse (OASIS).
Recruitment status was: Recruiting
First Posted : October 19, 2005
Last Update Posted : October 25, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence HIV Infections||Behavioral: Integrating drug treatment into HIV services||Phase 4|
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 (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model|
|Study Start Date :||September 2005|
|Study Completion Date :||February 2009|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241930
|Contact: Diana L Sylvestre, MDfirstname.lastname@example.org|
|Contact: Laphyne Barrettemail@example.com|
|United States, California|
|Alameda County Medical Center HIV Clinic||Recruiting|
|Oakland, California, United States, 94602|
|Contact: Lance Smith 510-437-4888|
|Contact: Silver Sisneros, MD 510-437-4891 firstname.lastname@example.org|
|Principal Investigator: Silver Sisneros, DO|
|Oakland, California, United States, 94612|
|Contact: Laphyne Barrett 510-834-5442 email@example.com|
|Principal Investigator: Diana L Sylvestre, MD|
|Fairmont Hospital HIV Clinic||Recruiting|
|San Leandro, California, United States, 94578|
|Contact: Lance Smith 510-437-4888|
|Contact: Beth Schweitzer, MD 510-667-3201|
|Principal Investigator: Beth Schweitzer, MD|
|Principal Investigator:||Diana L Sylvestre, MD||Organization to Achieve Solutions in Substance Abuse (OASIS)|
|Study Director:||Ruth Finkelstein, ScD||New York Academy of Medicine|