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NCT01857245 · ClinicalTrials.gov registry record · NA
Intensive Models of HCV Care for Injection Drug Users
A NA study, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT01857245 is a NA study that has completed, run by Prisma Health-Upstate. The registered enrollment target is 150 participants.
The verdict
NCT01857245, a NA study, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if applicable, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections, if applicable. It is unknown whether either model is better or more cost-effective than standard on-site care. PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our
Interventions
- OTHER Intensive Models (mDOT and CGT) of HCV Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2017-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01857245
The ClinicalTrials.gov registry entry for NCT01857245 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prisma Health-Upstate, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intensive Models (mDOT and CGT) of HCV Care is the first listed.
NCT01857245 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01857245 about?
NCT01857245 is a clinical study titled "Intensive Models of HCV Care for Injection Drug Users". Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV t...
What is the current status of trial NCT01857245?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2013-10-01. Estimated completion is 2017-04-30.
What interventions are being tested in trial NCT01857245?
The interventions under investigation include: Intensive Models (mDOT and CGT) of HCV Care (OTHER).
Who is sponsoring clinical trial NCT01857245?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
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