The DETECT HCV Linkage to Care Trial

Hepatitis C Clinical Trial

— DETECT HCV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04026867
• Other study ID #: 17-2327
• Secondary ID: R01DA042982
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 309
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ED patients who test positive for HCV antibodies

• ED patients who have discharged and confirmatory RNA result is positive

• Clinically stable per screening nurse or physician assessment

• Able to provide consent

• ED patients with untreated active HCV confirmed by the electronic medical record

Exclusion Criteria:

• Younger than 18 years of age

• Prisoners

• Pregnant women

• Individuals that live out of state

• Unable to consent for care (e.g., altered mentation, critical illness or injury)

• Non English or Spanish speaking

• Have already participated in the trial

Related Conditions & MeSH terms

• Hepatitis C

Intervention

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.
• Clinician Referral
The Clinician Referral arm will serve as an "active control" and baseline standard of care.

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	For individuals who self-identify as a person who injects drugs (PWID), the number of individuals who initiate substance use disorder services within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).	Measured by indication of a completed visit with a substance use treatment provider. This will be verified via electronic medical record review.	Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Other	Number of individuals who complete their full course of HCV treatment with DAAs within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).	Measured by indication of completion of treatment with DAAs among those individuals identified with active HCV. This will be verified by electronic medical record review.	Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Other	Number of individuals who have documented sustained virologic response 12 weeks after completing treatment with DAAs within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).	Rates of sustained virologic response within 12 weeks (SVR12) will be measured by report of undetectable HCV RNA Nucleic Acid Amplification Test (NAAT) 12 weeks after completion of DAAs among those identified with active HCV. This will be verified by electronic medical record review.	Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Primary	Number of individuals who fill a prescription for Direct-Acting Antivirals (DAAs) for hepatitis C within 6 months of positive HCV RNA test (for new HCV diagnosis) or presenting at ED visit (for those identified with untreated, active HCV).	The primary outcome will be the number of individuals with positive HCV RNA test who initiate HCV treatment within 6 months from the time of ED diagnosis (for new HCV diagnoses) or from time of ED visit (for those identified with untreated, active HCV). This will be verified by electronic medical record review.	Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for those identified with untreated, active HCV).
Secondary	Number of individuals who attend an appointment with an HCV treatment provider within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).	Measured by indication of a completed visit with an HCV treatment provider among those identified with active HCV. This will be verified by electronic medical record review.	Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses)