Buprenorphine, Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorder, Drug Use Disorders, HIV, Opiate Addiction, Substance Abuse, Substance-related Disorders
Conditions
Keywords
Buprenorphine, HIV, Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Opiate Addiction, Substance-related disorders
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 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.
Interventions
OTHERServices will be provided at one site
Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..
OTHERServices remain dispersed; i.e., not centralized to one-location or provider.
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.
Sponsors
Waterbury Hospital
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| HIV-related health outcomes | at 1, 3, 6, 9, and 12 months |
| Quality of life | at 1, 3, 6, 9, and 12 months |
Countries
United States
Outcome results
None listed