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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: Completed NA study, sponsored by Prisma Health-Upstate.
NCT01857245 is a NA study that has completed, run by Prisma Health-Upstate. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.
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 |
What the finished NCT01857245 record still lists
NCT01857245 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01857245's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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