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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Yale University

Current Primary Outcome:

  • Substance use outcomes measured by self-report [ Time Frame: at 1, 3, 6, 9 and 12 months measured by self-report ]
  • Urine toxicology results [ Time Frame: at 1, 3, 6, 9 and 12 months ]
  • Retention in and adherence to HIV care [ Time Frame: at 1, 3, 6, 9 and 12 months ]


Original Primary Outcome:

  • Substance use outcomes measured by self-report [ Time Frame: at 1, 3 and 6 months measured by self-report ]
  • Urine toxicology results [ Time Frame: at 1, 3, 6, and 12 months ]
  • Retention in and adherence to HIV care [ Time Frame: at 1, 3, 6, and 12 months ]


Current Secondary Outcome:

  • Quality of life [ Time Frame: at 1, 3, 6, 9, and 12 months ]
  • HIV-related health outcomes [ Time Frame: at 1, 3, 6, 9, and 12 months ]


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: November 25, 2008
Date Started: August 2005
Date Completion:
Last Updated: July 23, 2015
Last Verified: July 2015