@article{cf60aefb04d84c2ba1e9d47ef8a261c0,
title = "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",
abstract = "Background: Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. 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) Linkage-to-Care Trial. Methods: The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O{\textquoteright}Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression. Discussion: When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV. Trial registration: ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867",
keywords = "Clinical trial, Comparative effectiveness, Emergency department, HCV, Hepatitis C, Implementation, Linkage-to-care, Methods, Navigation, Randomized trial",
author = "{for The DETECT Hep C Trials Investigators} and Rowan, {Sarah E.} and Jason Haukoos and Kamis, {Kevin F.} and Emily Hopkins and Stephanie Gravitz and Carolynn Lyle and Al-Tayyib, {Alia A.} and Gardner, {Edward M.} and Galbraith, {James W.} and Hsieh, {Yu Hsiang} and Lyons, {Michael S.} and Rothman, {Richard E.} and White, {Douglas A.E.} and Morgan, {Jake R.} and Linas, {Benjamin P.} and Sabel, {Allison L.} and Wyles, {David L.} and Amy Adler and Musheng Alishahi and Avornu, {Gideon D.} and Alexis Becerra and Erika Becerra-Ashby and Meghan Bellamy and Samantha Bot and Boyle, {Alexander J.} and Bracey, {Annetta M.} and Michael Breyer and Claudia Camacho and Alicia Cupelo and Gaby Dashler and Pamela Doyle and Amy Eicher and Heather Gardner and {de Gruiter}, {Carrie Anne} and Sophia Henry and David Higgins and Trevor Hill and Rachel Houk and Nyah Johnson and Alex Kile and Janet Liebl and Barbara Maliszewski and Kendall Maliszewski and Robert McGoey and Catherine McKenzie and Minturn, {Matthew S.} and Deanna Myer and Kendra Neumann and Cole Ossian and Bradley Shy",
note = "Funding Information: Additional members of The DETECT Hep C Trials Investigators include: Amy Adler, RN (Denver), Musheng Alishahi, MPH (Denver), Gideon D. Avornu, MS (Baltimore), Alexis Becerra, MA (Baltimore), Erika Becerra-Ashby, MD (Denver), Meghan Bellamy, MPH (Denver), Samantha Bot, MSN, RN (Baltimore), Alexander J. Boyle, EMT (Denver), Annetta M. Bracey, MHS (Jackson), Michael Breyer, MD (Denver), Claudia Camacho, BA (Denver), Alicia Cupelo, MSW (Denver), Gaby Dashler, BS (Baltimore), Pamela Doyle, RN (Denver), Amy Eicher, BS (Jackson), Heather Gardner, MSN (Baltimore), Carrie Anne de Gruiter, BS (Jackson), Sophia Henry, MS, RN (Baltimore), David Higgins, MD, MS (Denver), Trevor Hill, BA (Baltimore), Rachel Houk, BA (Denver), Nyah Johnson, BS (Baltimore), Alex Kile, BS (Jackson), Janet Liebl, BS (Jackson), Barbara Maliszewski, MS, RN (Baltimore), Kendall Maliszewski, BS (Baltimore), Robert McGoey, BA (Denver), Catherine McKenzie, BSN, RN (Baltimore), Matthew S. Minturn, MD (Denver), Deanna Myer, BS (Baltimore), Kendra Neumann, BA (Denver), Cole Ossian, MS (Denver), Rebekah K. Peacock, RN (Jackson), Danielle Perez, BS (Baltimore), Tannishtha Pramanick, BA (Boston), Erin P. Ricketts, MSPH (Baltimore), Benji Riggan (Baltimore), Sherry Riser, MBA (Jackson), Genie Roosevelt, MD, MPH (Denver), Mustapha Saheed, MD (Baltimore), Sarah Schumacher (Boston), Bradley Shy, MD (Denver), Scott Simpson, MD (Denver), Matthew F. Toerper, MS (Baltimore), Gil Trest (Jackson), Madison Unsworth, MA (Denver), Laura Waltrous, RN (Jackson), Brooke Watson, RN (Denver). Funding Information: Funding for this trial is provided by the National Institute on Drug Abuse (NIDA) (R01DA042982). The trial sponsor had no role in the design, conduct, or reporting of this trial. Funding Information: JSH has received grant funding from the Centers for Disease Control and Prevention (CDC) (R01CE003006). SER and KFK have received grant funding from Gilead Sciences, Inc. JRM has received grant funding from the National Institute on Drug Abuse (NIDA) (P30DA040500). EMG serves as site principal investigator for clinical trials sponsored by Cepheid, Gilead Science, and Viiv Healthcare. MSL and DAEW receive investigator-initiated grant support paid to the institution from Gilead Sciences. All other authors report no conflicts of interest. Publisher Copyright: {\textcopyright} 2023, The Author(s).",
year = "2023",
month = dec,
doi = "10.1186/s13063-022-07018-w",
language = "English",
volume = "24",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd.",
number = "1",
}