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
Authors: Haukoos Jason S. , Rowan Sarah E. , Galbraith James W. , Rothman Richard E. , Hsieh Yu-Hsiang , Hopkins Emily , Houk Rachel A. , Toerper Matthew F. , Kamis Kevin F. , Morgan Jake R. , Linas Benjamin P. , Al-Tayyib Alia A. , Gardner Edward M. , Lyons Michael S. , Sabel Allison L. , White Douglas A. E. , Wyles David L. ,   for The DETECT Hep C Trials Investigators, Adler Amy , Alishahi Musheng , Avornu Gideon D. , Becerra Alexis , Becerra-Ashby Erika , Bot Samantha , Boyle Alexander J. , Bracey Annetta M. , Breyer Michael , Camacho Claudia , Cupelo Alicia , Dashler Gaby , Doyle Pamela , Eicher Amy , Gardner Heather , de Gruiter Carrie Anne , Gravitz Stephanie , Henry Sophia , Higgins David , Hill Trevor , Johnson Nyah , Kile Alex , Liebl Janet , Lyle Carolynn , Maliszewski Barbara , Maliszewski Kendall , McGoey Robert , McKenzie Catherine , Minturn Matthew S. , Myer Deanna , Neumann Kendra , Ossian Cole , Peacock Rebekah K. , Perez Danielle , Pramanick Tannishtha , Ricketts Erin P. , Riggan Benji , Riser Sherry , Roosevelt Genie , Saheed Mustapha , Shy Bradley , Simpson Scott , Trest Gil , Unsworth Madison , Waltrous Laura , Watson Brooke 
Published: April 2022

Background

Early identification of HCV is a critical health priority, especially now that treatment options are available to limit further transmission and provide cure before long-term sequelae develop. Emergency departments (EDs) are important clinical settings for HCV screening given that EDs serve many at-risk patients who do not access other forms of healthcare. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial.

Methods

The DETECT Hep C Screening Trial is a multi-center prospective pragmatic randomized two-arm parallel-group superiority trial to test the comparative effectiveness of nontargeted and targeted HCV screening in the ED with a primary hypothesis that nontargeted screening is superior to targeted screening when identifying newly diagnosed HCV. This trial will be performed in the EDs at Denver Health Medical Center (Denver, CO), Johns Hopkins Hospital (Baltimore, MD), and the University of Mississippi Medical Center (Jackson, MS), sites representing approximately 225,000 annual adult visits, and designed using the PRECIS-2 framework for pragmatic trials. When complete, we will have enrolled a minimum of 125,000 randomized patient visits and have performed 13,965 HCV tests. In Denver, the Screening Trial will serve as a conduit for a distinct randomized comparative effectiveness trial to evaluate linkage-to-HCV care strategies. All sites will further contribute to embedded observational studies to assess cost effectiveness, disparities, and social determinants of health in screening, linkage-to-care, and treatment for HCV.

Discussion

When complete, The DETECT Hep C Screening Trial will represent the largest ED-based pragmatic clinical trial to date and all studies, in aggregate, will significantly inform how to best perform ED-based HCV screening.

Trial registration

ClinicalTrials.gov ID: NCT04003454. Registered on 1 July 2019.