The DETECT HCV Screening Trial (DETECT HCV)

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

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").

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Other: HCV Screening

Detailed Description

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 electronic health records (EHRs) for each ED. Patients will therefore be offered HCV testing based on the result of the screening arm to which they are assigned, and in the case of the targeted arm, the results of the risk assessment evaluation performed by the intake nurse. All randomization will be completely integrated into electronic medical screening systems and workflow at each site. Integration of randomization into the electronic systems will allow for real-time concealed random allocation. Nurses who perform screening and all other ED staff (e.g. physicians, technicians) will understand the conceptual goals of the project but will be blinded to study hypotheses, and patients will be completely blinded to the purpose of the study.

This study will be performed at multiple sites, including the EDs at Denver Health Medical Center (DHMC) (Denver, Colorado), Johns Hopkins Hospital (JHH) (Baltimore, Maryland), and the University of Mississippi Medical Center (UMMC) (Jackson, Mississippi).

• Study Type: Interventional
• Enrollment (Actual): 147533
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nontargeted Screening; The nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening.	Other: HCV Screening; 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.
Other: Targeted Screening; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV test acceptance	Defined by the proportion of patients who agree to HCV testing, as measured by the proportion of those who consent among patients offered HCV testing, stratified by study arm	1 day from ED visit
HCV test completion	Defined by the proportion of patients who complete HCV testing, as measured by the proportion of rapid HCV tests completed among patients who accepted testing, stratified by study arm	1 day from ED visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV genotype among those identified with active HCV	Measured by HCV genotyping among those identified with active HCV	12 months following HCV diagnosis
Fibrosis staging	Measured by standard of care fibrosis staging approaches (e.g. biopsy, ultrasound, FibroTest, etc.) among those identified with active HCV	12 months following HCV diagnosis
Completion of an evaluation by an HCV treatment expert	Measured by indication of a completed visit with an HCV treatment expert among those identified with active HCV	12 months following HCV diagnosis
Initiation of treatment with Direct-Acting Antivirals (DAAs)	Measured by indication of initiation of treatment with DAAs among those identified with active HCV	12 months following HCV diagnosis
Completion of treatment with Direct-Acting Antivirals (DAAs)	Measured by indication of completion of treatment with DAAs among those identified with active HCV	12 months following HCV diagnosis
Sustained virologic response at 12 weeks after treatment completion (SVR12)	Measured by undetectable HCV RNA 12 weeks after completion of DAAs among those identified with active HCV	12 months following HCV diagnosis

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: Boston University; Johns Hopkins University; Boston Medical Center; University of Cincinnati; University of Mississippi Medical Center; Alameda County Medical Center
• Investigators: Principal Investigator: Sarah Rowan, MD, Denver Health; Principal Investigator: Jason Haukoos, MD, MSc, Denver Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; Screening; Hepatitis C; Risk
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C
• Other Study ID Numbers: R01DA042982 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No