Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

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. In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.

Official Title
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Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

Conditions
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Buprenorphine, HIV, Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Opiate Addiction, Substance-related Disorders

Intervention / Treatment
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* Other: Services will be provided at one site
* Other: Services remain dispersed; i.e., not centralized to one-location or provider.


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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integrated<br>Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic. | Other: Services will be provided at one site<br>* Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..<br>|
| Placebo Comparator: Non-integrated<br>Buprenorphine induction, substance abuse counseling and HIV care will be managed at multiple locations, respectively: the Community Health Care Van, the Yale AIDS Program, and individuals' HIV clinics. | Other: Services remain dispersed; i.e., not centralized to one-location or provider.<br>* Buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use outcomes measured by self-report |  | at 1, 3, 6, 9 and 12 months measured by self-report | 
| Urine toxicology results |  | at 1, 3, 6, 9 and 12 months | 
| Retention in and adherence to HIV care |  | at 1, 3, 6, 9 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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Buprenorphine, HIV, Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Opiate Addiction, Substance-related disorders