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

NCT00798538 | Completed Phase 4

• 1 other identifier: H97HA03800-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Buprenorphine; HIV; Drug Abuse; Drug Addiction; Drug Dependence; Drug Use Disorders; Drug Use Disorder; Substance Abuse; Opiate Addiction; Substance-related disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Quality of life

  at 1, 3, 6, 9, and 12 months

• HIV-related health outcomes

  at 1, 3, 6, 9, and 12 months

Study Arms (2)

Integrated

ACTIVE COMPARATOR

Provision of buprenorphine induction and management, substance abuse counseling and HIV care at one clinic.

Other: Services will be provided at one site

Non-integrated

PLACEBO COMPARATOR

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.

Interventions

Services will be provided at one site OTHER

Provision of buprenorphine induction and management, substance abuse counseling and HIV care will be provided at one clinic: the Waterbury Hospital Infectious Disease Clinic..

Integrated

Services remain dispersed; i.e., not centralized to one-location or provider. OTHER

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.

Non-integrated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected
• Clinical diagnosis of opioid dependence
• Fluent in English or Spanish
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Waterbury Hospital: collaborator
• Health Resources and Services Administration (HRSA): collaborator
• The New York Academy of Medicine: collaborator

Study Sites (1)

Yale AIDS Program

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Frederick Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: August 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

US (1)