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

HIV Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798538
• Other study ID #: H97HA03800-03
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2008
• Last updated: July 23, 2015
• Start date: August 2005
• Est. completion date: August 2010

Study information

• Verified date: July 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Behavior, Addictive
• Buprenorphine
• Disease
• Drug Abuse
• Drug Addiction
• Drug Dependence
• Drug Use Disorder
• Drug Use Disorders
• HIV
• Opiate Addiction
• Substance Abuse
• Substance-related Disorders

Intervention

Other:
• Services 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..
• Services 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.

Locations

Country	Name	City	State
United States	Yale AIDS Program	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	Health Resources and Services Administration (HRSA), The New York Academy of Medicine, Waterbury Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use outcomes measured by self-report		at 1, 3, 6, 9 and 12 months measured by self-report	No
Primary	Urine toxicology results		at 1, 3, 6, 9 and 12 months	No
Primary	Retention in and adherence to HIV care		at 1, 3, 6, 9 and 12 months	No
Secondary	Quality of life		at 1, 3, 6, 9, and 12 months	No
Secondary	HIV-related health outcomes		at 1, 3, 6, 9, and 12 months	No