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
2 other identifiers
interventional
60
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2005
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedOctober 25, 2005
August 1, 2005
October 17, 2005
October 24, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
1. Acceptability of HIV treatment-based buprenorphine therapy
2. Health services utilization
Interventions
Eligibility Criteria
You may qualify if:
- HIV+ as verified by lab report
- DSM-IV diagnosis of opioid dependence
- Speaks/understands English
- Age 18 years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Alameda County Medical Center HIV Clinic
Oakland, California, 94602, United States
OASIS
Oakland, California, 94612, United States
Fairmont Hospital HIV Clinic
San Leandro, California, 94578, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana L Sylvestre, MD
Organization to Achieve Solutions in Substance Abuse (OASIS)
- STUDY DIRECTOR
Ruth Finkelstein, ScD
New York Academy of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 19, 2005
Study Start
September 1, 2005
Study Completion
February 1, 2009
Last Updated
October 25, 2005
Record last verified: 2005-08