Skip to main content
OpenTrials
Completed

NCT Number: NCT00798538

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Buprenorphine Chemically-Induced Disorders Drug Abuse Drug Addiction Drug Dependence Drug Use Disorder Drug Use Disorders HIV Mental Disorders Narcotic-Related Disorders Opiate Addiction Opioid-Related Disorders Substance Abuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale AIDS Program

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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..

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.

Primary outcomes

  1. Substance use outcomes measured by self-report

    Time frame: at 1, 3, 6, 9 and 12 months measured by self-report

  2. Urine toxicology results

    Time frame: at 1, 3, 6, 9 and 12 months

  3. Retention in and adherence to HIV care

    Time frame: at 1, 3, 6, 9 and 12 months

Secondary outcomes

  1. Quality of life

    Time frame: at 1, 3, 6, 9, and 12 months

  2. HIV-related health outcomes

    Time frame: at 1, 3, 6, 9, and 12 months

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Health Resources and Services Administration (HRSA)
  • The New York Academy of Medicine
  • Waterbury Hospital

Registry information

Acronym: BELIEVE

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2008
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.