Buprenorphine HIV Care Integration Project
A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
Behavioral: enhanced behavioral motivation counseling
Behavioral: Motivational counseling
Behavioral: Standard counseling
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Miami Buprenorphine HIV Care Integration Project|
- The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence [ Time Frame: week 48 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
enhanced behavioral motivation counseling
|Behavioral: enhanced behavioral motivation counseling Behavioral: Motivational counseling|
|Active Comparator: 2||Behavioral: Standard counseling|
DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.
SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.
POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.
STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)
INTERVENTON At entry subjects will be randomized to one of the following:
ARM A: Standard drug addiction counseling + buprenorphine / naloxone
ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone
The three primary outcomes are:
- Cessation of illicit opioid use
- Reduction in high risk behavior
- Improved HIV therapy adherence
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348868
|United States, Florida|
|University of Miami AIDS Clinical Reserach Unit|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Margaret Fischl, M.D.||University of Miami|