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NCT02824640 · ClinicalTrials.gov registry record · NA
Patient-Centered Models of HCV Care for People Who Inject Drugs
A NA study of Hepatitis C and Medication Adherence, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- NA
- Development phase
- 755
- Enrollment target
- 1
- Study location
NCT02824640: Completed NA study of Hepatitis C and Medication Adherence, sponsored by Prisma Health-Upstate.
NCT02824640 is a NA study of Hepatitis C and Medication Adherence that has completed, run by Prisma Health-Upstate. The registered enrollment target is 755 participants, below the 1,883-participant average among 106 other Hepatitis C trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02824640, a NA study of Hepatitis C and Medication Adherence, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- NA
- Development phase
- 755 participants
- Enrollment target
- 1
- Study location
Study Summary
People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive, so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to prescribe DAAs because they are concerned that PWID won't take their medication or that these patients might become reinfected. Several good models for treating PWID exist. One of them is to provide directly observed treatment (DOT). Another model provides treatment to PWID with the support of patient navigators (PN), public health workers who offer support and education to patients. Though both the DOT and PN models have been successful, we still don't know which model works best. In this study, the investigators will study both DOT and PN models for treating HCV in PWID. The investigators' goal is to find out which model produces the best results and is preferred by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight sites around the country. Patients will be randomized into either the PN or the DOT groups. Patients who end up in the PN group will get a biweekly blister pack of medication to take home. Their PN will provide education and support. The investigators will find out whether patients adhered to medication using an electronic adherence monitoring system. Patients who are randomly assigned to the DOT group will take their medication in front of a staff member.
Primary Outcome
HCV viral load undetectable 12 weeks after treatment completion.
Conditions Studied
Interventions
- BEHAVIORAL Patient Navigation
- BEHAVIORAL modified Directly Observed Therapy
Study Locations (1)
New York
- Alain Litwin - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 755 participants |
| Start Date | 2016-09-15 |
| Est. Completion | 2021-08-04 |
| Phase | NA |
What the finished NCT02824640 record still lists
NCT02824640 is an interventional study that assigns participants to a tested intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap, below the 1,883-participant average among 106 other Hepatitis C trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which Patient Navigation is the first listed.
NCT02824640 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02824640 about?
NCT02824640 is a clinical study titled "Patient-Centered Models of HCV Care for People Who Inject Drugs". People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive, so insurers often do n...
What is the current status of trial NCT02824640?
This trial is currently completed. It is a NA study. The enrollment target is 755 participants. The study started on 2016-09-15. Estimated completion is 2021-08-04.
What conditions does trial NCT02824640 study?
This clinical trial studies the following conditions: Hepatitis C, Medication Adherence.
What interventions are being tested in trial NCT02824640?
The interventions under investigation include: Patient Navigation (BEHAVIORAL), modified Directly Observed Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02824640?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02824640 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02824640's enrollment target sits among peer trials
755 11th of 106 higher than 96 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C 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.
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