Clinical trial NCT04003454: The DETECT HCV Screening Trial
Official title: The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Hepatitis C
Screening
Emergency Department
Risk
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Mississippi Medical Center
name: Boston University
name: Boston Medical Center
name: University of Cincinnati
name: Alameda County Medical Center
First posted: 2019-07-01
Enrollment: 147533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients presenting to the emergency department will be randomized to targeted HCV screening or nontargeted HCV screening
Primary purpose: SCREENING

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").

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).

Eligibility criteria: 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

Primary outcomes:
measure: Newly diagnosed active HCV
timeFrame: 1 day from ED visit
Secondary outcomes:
measure: HCV test acceptance
timeFrame: 1 day from ED visit
measure: HCV test completion
timeFrame: 1 day from ED visit
Other outcomes:
measure: HCV genotype among those identified with active HCV
timeFrame: 12 months following HCV diagnosis
measure: Fibrosis staging
timeFrame: 12 months following HCV diagnosis
measure: Completion of an evaluation by an HCV treatment expert
timeFrame: 12 months following HCV diagnosis
measure: Initiation of treatment with Direct-Acting Antivirals (DAAs)
timeFrame: 12 months following HCV diagnosis
measure: Completion of treatment with Direct-Acting Antivirals (DAAs)
timeFrame: 12 months following HCV diagnosis
measure: Sustained virologic response at 12 weeks after treatment completion (SVR12)
timeFrame: 12 months following HCV diagnosis
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Denver Health
name: Jason Haukoos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Health
name: Sarah Rowan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.