Viewing Study NCT00124358



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Study NCT ID: NCT00124358
Status: UNKNOWN
Last Update Posted: 2007-03-27
First Post: 2005-07-25

Brief Title: Buprenorphine and Integrated HIV Care Evaluation
Sponsor: The New York Academy of Medicine
Organization: The New York Academy of Medicine

Study Overview

Official Title: An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings
Status: UNKNOWN
Status Verified Date: 2007-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to assess the feasibility cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the US
Detailed Description: Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes The overlap in the epidemics of HIV with its complex medical needs and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people However little is known about implementing such programs in HIV care settings their cost what effect they have on the health outcomes and substance use behavior of PLWHA or their broader impact on providers institutions and local systems

Through this study approximately 1350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the US Information on patients drug use HIV health status service utilization quality of life and satisfaction with services as well as information about providers practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews audio computer-assisted self-interviewing written surveys and chart abstractions These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals

Comparisons All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention However the program designs and comparison group interventions vary across the sites and are locally determined Some sites will implement randomized control designs while others will use observational methods

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
H97HA03795 None None None