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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00241930
Enrollment
60
Registered
2005-10-19
Start date
2005-09-30
Completion date
2009-02-28
Last updated
2005-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Opiate Dependence

Keywords

Heroin, HIV, buprenorphine, integration, drug treatment

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.

Detailed description

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.

Interventions

BEHAVIORALIntegrating drug treatment into HIV services

Sponsors

Organization to Achieve Solutions in Substance Abuse (OASIS)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Acceptability of HIV treatment-based buprenorphine therapy
2. Health services utilization

Countries

United States

Contacts

Primary ContactDiana L Sylvestre, MD
dsylves@itsa.ucsf.edu510-834-5442
Backup ContactLaphyne Barrett
oasisclinic@sbcglobal.net510-834-5442

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026