The DETECT HCV Screening Trial

NCT04003454 | Completed

• 1 other identifier: R01DA042982
• Study Type: interventional
• Target: 147,533
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - "Screening Trial").

Conditions

Hepatitis C

Keywords

Hepatitis C; Screening; Emergency Department; Risk

Outcome Measures

Primary Outcomes (1)

• Newly diagnosed active HCV

  Confirmed cases of newly diagnosed active HCV, defined as patients who test positive for HCV antibody and measurable HCV RNA, and without a prior HCV diagnosis, stratified by study arm

  1 day from ED visit

Secondary Outcomes (2)

• HCV test acceptance

  1 day from ED visit

• HCV test completion

  1 day from ED visit

Other Outcomes (6)

• HCV genotype among those identified with active HCV

  12 months following HCV diagnosis

• Fibrosis staging

  12 months following HCV diagnosis

• Completion of an evaluation by an HCV treatment expert

  12 months following HCV diagnosis

Study Arms (2)

Nontargeted Screening

OTHER

The nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening.

Other: HCV Screening

Targeted Screening

OTHER

The targeted HCV screening arm will consist of implementation of risk-based rapid opt-out HCV screening using current recommendations for HCV screening by the CDC, USPSTF, and AASLD-IDSA. Targeted HCV screening will consist of offering HCV testing to those identified with the following specific risk characteristics, adapted from the above recommendations: born between 1945 - 1965 ("birth cohort"); injection drug use (IDU); intranasal drug use;tattoo or piercing in an unregulated setting; or blood transfusion or organ recipient before 1992.

Other: HCV Screening

Interventions

HCV Screening OTHER

The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing EHRs for each ED.

Nontargeted Screening; Targeted Screening

Eligibility Criteria

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

You may qualify if:

• Present to EDs during study enrollment period
• Clinically stable per screening nurse or physician assessment
• Able to provide consent for medical care

You may not qualify if:

• Younger than 18 years of age
• Are unable to consent for care (i.e., altered mentation, critical illness, or injury)
• Have already participated in the trial
• Self-Identify as already living with HCV

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Johns Hopkins University: collaborator
• University of Mississippi Medical Center: collaborator
• Boston University: collaborator
• Boston Medical Center: collaborator
• University of Cincinnati: collaborator
• Alameda County Medical Center: collaborator

Study Sites (3)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (2)

• Haukoos J, Rothman RE, Galbraith JW, Hopkins E, Hsieh YH, Lyle C, Gravitz S, Kamis KF, White DAE, Lyons MS, Gardner EM, Al-Tayyib AA, Sabel AL, Linas BP, Morgan JR, Wyles DL, Rowan SE; DETECT Hep C Screening Trial Investigators. Hepatitis C Screening in Emergency Departments: The DETECT Hep C Randomized Clinical Trial. JAMA. 2025 Aug 12;334(6):497-507. doi: 10.1001/jama.2025.10563.

  PMID: 40632510 DERIVED

• Haukoos JS, Rowan SE, Galbraith JW, Rothman RE, Hsieh YH, Hopkins E, Houk RA, Toerper MF, Kamis KF, Morgan JR, Linas BP, Al-Tayyib AA, Gardner EM, Lyons MS, Sabel AL, White DAE, 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) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments. Trials. 2022 Apr 25;23(1):354. doi: 10.1186/s13063-022-06265-1.

  PMID: 35468807 DERIVED

MeSH Terms

Conditions

Hepatitis C; Emergencies

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Haukoos, MD, MSc

  Denver Health

  PRINCIPAL INVESTIGATOR

• Sarah Rowan, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Patients presenting to the emergency department will be randomized to targeted HCV screening or nontargeted HCV screening

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: July 1, 2019
• Study Start: November 20, 2019
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 6, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)