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NCT00798538 · ClinicalTrials.gov registry record · Phase 4
Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)
A Phase 4 study of HIV and Substance-Related Disorders, sponsored by Yale University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00798538 is a Phase 4 study of HIV and Substance-Related Disorders that has completed, run by Yale University. The registered enrollment target is 60 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00798538, a Phase 4 study of HIV and Substance-Related Disorders, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Services will be provided at one site
- OTHER Services remain dispersed; i.e., not centralized to one-location or provider.
Study Locations (1)
Connecticut
- Yale AIDS Program - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-08 |
| Est. Completion | 2010-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00798538
The ClinicalTrials.gov registry entry for NCT00798538 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (86% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Services will be provided at one site is the first listed.
NCT00798538 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT00798538 about?
NCT00798538 is a clinical study titled "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 an...
What is the current status of trial NCT00798538?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2005-08. Estimated completion is 2010-08.
What conditions does trial NCT00798538 study?
This clinical trial studies the following conditions: HIV, Substance-Related Disorders, Substance Abuse, Drug Abuse, Drug Addiction.
What interventions are being tested in trial NCT00798538?
The interventions under investigation include: Services will be provided at one site (OTHER), Services remain dispersed; i.e., not centralized to one-location or provider. (OTHER).
Who is sponsoring clinical trial NCT00798538?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00798538 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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