The DETECT HCV Linkage to Care Trial

NCT04026867 | Completed

• 2 other identifiers: 17-2327R01DA042982
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

  Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses)

Other Outcomes (3)

• 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).

  Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

• 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).

  Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

• 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).

  Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

Study Arms (2)

Clinician Referral Only

ACTIVE COMPARATOR

The Clinician Referral arm will serve as an "active control" and baseline standard of care. All individuals who test positive for HCV antibodies or are identified with untreated, active HCV will be informed of their result and receive the following information from their clinical care teams in the ED: (a) explanation of process and rationale for follow-up RNA testing; (b) delivery of simple posttest counseling (e.g., risk for liver disease, risks of transmission); and (c) provision of a list of insurance enrollment resources, as needed, along with (d) a list of HCV treatment providers and their contact information as provided in aftercare instructions. For new HCV diagnoses, patients will be instructed to access their electronic patient portal (MyChart) for their RNA test results or to call a designated results line. Post-testing counseling messages and follow-up instructions will be included on the patient discharge papers.

Other: Clinician Referral

Clinician Referral + Linkage Navigation

EXPERIMENTAL

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). Individuals randomized to this intervention will be contacted by a linkage navigator either during the ED visit (if during business hours) or the following business day (if during non-business hours). If the navigator does not contact the patient at the time of ED visit, they will offer to meet with the patient in person or over the phone. For all individuals in this arm, a structured linkage navigation process will include motivational interviewing and (a) reiteration of posttest counseling messages, (b) assessment of the patient's needs for medical insurance and substance abuse treatment, c) assistance scheduling and/or rescheduling appointments for HCV treatment, and d) follow-up phone call after the first HCV treatment appointment and thereafter as needed up to 6 months after ED visit.

Other: Linkage Navigation; Other: Clinician Referral

Interventions

Linkage Navigation OTHER

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 + Linkage Navigation

Clinician Referral OTHER

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

Clinician Referral + Linkage Navigation; Clinician Referral Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• Rowan SE, Haukoos J, Kamis KF, Hopkins E, Gravitz S, Lyle C, Al-Tayyib AA, Gardner EM, Galbraith JW, Hsieh YH, Lyons MS, Rothman RE, White DAE, Morgan JR, Linas BP, Sabel AL, Wyles DL; DETECT Hep C Trials Investigators. The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C. Trials. 2023 Jan 27;24(1):63. doi: 10.1186/s13063-022-07018-w.

  PMID: 36707909 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Sarah Rowan, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

• Jason Haukoos, MD, MSc

  Denver Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Director of Research, Department of Emergency Medicine, Denver Health

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 19, 2019
• Study Start: November 20, 2019
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)