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NCT03441542 · ClinicalTrials.gov registry record · NA
Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital
A NA study, sponsored by National Opinion Research Center.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT03441542 is a NA study that was terminated before completion, run by National Opinion Research Center. The registered enrollment target is 6 participants.
The verdict
NCT03441542, a NA study, was terminated before completion, sponsored by National Opinion Research Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid substitution therapy (OST). The study will use data from a previously developed patient registry system to identify patients for study recruitment, and use monthly updates of registry data to organize and direct patient navigation services for those individuals assigned to the treatment group. Patients assigned to the control group will also be eligible to receive HCV treatment, but will otherwise receive usual care. This study has a parallel, randomized unblinded, case/control design in which eligible patients are assigned at baseline to either a registry-directed patient navigation system (case) or to usual care (control), characterized in terms of demographic and sub-population variables, and then compared after 12 months on two categories of outcomes; (1) attainment of care cascade milestones; and (2) treatment initiation, adherence, and virologic response. The study is designed and powered to answer two primary hypotheses (H1 \& H2): * H1: As compared to those randomized to usual care (control), those randomized to the registry directed patient navigation arm (case) will be more likely to complete all pretreatment HCV care milestones as defined by a higher proportion completing all four pre-treatment care cascade outcomes. * H2: As compared to the control group, a significantly higher proportion of those randomized to the case group will achieve a sustained viral response.
Interventions
- BEHAVIORAL Standard of Care
- BEHAVIORAL Data-assisted Case Navigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2019-02-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03441542
The ClinicalTrials.gov registry entry for NCT03441542 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Opinion Research Center, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03441542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03441542 about?
NCT03441542 is a clinical study titled "Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital". This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid substitution therapy (OST). The study will use data from a previously developed patient registry sys...
What is the current status of trial NCT03441542?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2018-07-23. Estimated completion is 2019-02-15.
What interventions are being tested in trial NCT03441542?
The interventions under investigation include: Standard of Care (BEHAVIORAL), Data-assisted Case Navigation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03441542?
This trial is sponsored by National Opinion Research Center, which has 10 total clinical trials registered on ClinicalTrials.gov.
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