Buprenorphine and Integrated HIV Care Evaluation

Study Overview
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Brief Summary
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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 U.S.

Detailed Description
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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 PLWH/A, or their broader impact on providers, institutions, and local systems. Through this study, approximately 1,350 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 U.S. 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.

Official Title
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An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings

Conditions
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Opioid-Related Disorders, HIV Infections, AIDS

Intervention / Treatment
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* Drug: Buprenorphine
* Behavioral: Integrated HIV care and office-based opioid dependence treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected Clinical diagnosis of opioid dependence Fluent in English or Spanish 18 years or older Exclusion Criteria: Liver function tests (transaminase only) at five times or higher than normal level; Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months; DSM-IV criteria for alcohol dependence within the past 6 months; Actively suicidal; Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic); Methadone dose exceeding levels allowing for safe transition to buprenorphine; Pregnant women and women actively trying to become pregnant; Clinical judgment of local site principal investigator that patient is inappropriate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|
|Behavioral: Integrated HIV care and office-based opioid dependence treatment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use outcomes at 1, 3 and 6 months measured by self-report |  |  | 
| Urine toxicology results at 1, 3, 6, and 12 months |  |  | 
| Retention in and adherence to HIV care at 1, 3, 6, and 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life at 1, 3, 6, 9, and 12 months |  |  | 
| HIV-related health outcomes at 1, 3, 6, 9, and 12 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction, Substance-related disorders, HIV