Discussion
infectious diseases
INFECTIOUS DISEASES
When complete, the DETECT Hep C Linkage trial will represent the only randomized clinical trial to compare the effectiveness of different approaches to HCV linkage to care from the ED and to attempt to quantify the added benefit of a linkage navigator. Additionally, this trial will provide data on HCV linkage to care for patients identified with untreated HCV in an ED setting, a unique and promising venue for engaging patients with HCV. If linkage navigation plus clinician referral yields at least a 20% increase in HCV treatment initiation, this finding will have significant implications for clinical settings where HCV rates are high and where the addition of an HCV linkage navigator to hospital staff could yield major benefits to the community by decreasing HCV prevalence.Rationale for the head-to-head comparison performed in this trial resulted from prior findings that clinician referral from ED settings, while current standard of care has limited effectiveness [Potential limitations of this trial include its performance at a single academic medical center with experience performing infectious diseases screening in the ED and with integrated linkage-to-care services for HIV, but not HCV. While the navigation standard work was developed using an interdisciplinary group of programmatic and content experts and based on prior processes related to HIV screening and other navigation programs, success of navigation may be limited by complexities of navigating care for patients who are socially and economically vulnerable. Furthermore, secular trends related to the diagnosis and treatment of HCV may influence the numbers of patients identified with active chronic HCV, which may limit the ability to enroll, and conducting this trial during the COVID-19 pandemic has led to unanticipated delays and disruptions, including varying trends in access to care and the broader use of telehealth, which may also affect results. Finally, although the hypothesized effect was influenced by existing knowledge and content expertise, very little prior data existed to inform the hypothesized effect; therefore, depending on the true effect, this study may be underpowered.