NCT04026867

The DETECT HCV Linkage to Care Trial

Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
OTHER	Linkage Navigation	The Linkage Navigation arm will consist of an additional service layered onto clinician referral and will incorporate protocols from Antiretroviral Treatment and Access Studies (ARTAS), the most influential studies of HIV linkage-to-care to date.
OTHER	Clinician Referral	The Clinician Referral arm will serve as an "active control" and baseline standard of care.

Timeline

• Start date: 2019-11-20
• Primary completion: 2024-07-12
• Completion: 2024-07-12
• First posted: 2019-07-19
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States