Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-22 @ 12:56 AM
Study NCT ID:
NCT04026867
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DETECT HCV Linkage to Care Trial
Sponsor:
Denver Health and Hospital Authority
Organization:
Study Overview
Official Title:
Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECT HCV
Brief Summary:
This aim of the DETECT HCV linkage trial compares two linkage to care intervention strategies among (1) newly diagnosed HCV positive patients from the emergency department (ED) and (2) those patients who present to the ED with untreated active HCV. Patients who are positive for HCV and agree to be part of the study will be randomized to either clinician referral alone or clinician referral plus a linkage navigator.
Detailed Description:
The investigators will perform a prospective pragmatic randomized effectiveness trial to compare 2 linkage-to-care strategies. Permuted block randomization with 2 strata (i.e., \<40 years of age or active IDU \[defined as IDU within 30 days\], or ≥40 years of age without active IDU) and varying block sizes will be used to minimize imbalance, ensure appropriate numbers of patients in subgroups, and allow for efficient analyses. Allocation will be concealed by blinding block sizes and using the REDCap Randomization Module, a web-based platform to assign patients to arms (REDCap, Vanderbilt University, TN). Although patients will not be blinded to the interventions, they will be blinded to the outcomes. Also, a trained research assistant will perform all enrollment, including stratification and randomization. Clinical staff will not be blinded, however, to assignment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA042982 | NIH | None | https://reporter.nih.gov/quic… | View |