The DETECT HCV Linkage to Care Trial

Study Overview
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Brief Summary
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This aim of the DETECT HCV linkage trial compares two linkage to care intervention strategies among (1) newly diagnosed HCV positive patients from the emergency department (ED) and (2) those patients who present to the ED with untreated active HCV. Patients who are positive for HCV and agree to be part of the study will be randomized to either clinician referral alone or clinician referral plus a linkage navigator.

Detailed Description
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The investigators will perform a prospective pragmatic randomized effectiveness trial to compare 2 linkage-to-care strategies. Permuted block randomization with 2 strata (i.e., <40 years of age or active IDU [defined as IDU within 30 days], or ≥40 years of age without active IDU) and varying block sizes will be used to minimize imbalance, ensure appropriate numbers of patients in subgroups, and allow for efficient analyses. Allocation will be concealed by blinding block sizes and using the REDCap Randomization Module, a web-based platform to assign patients to arms (REDCap, Vanderbilt University, TN). Although patients will not be blinded to the interventions, they will be blinded to the outcomes. Also, a trained research assistant will perform all enrollment, including stratification and randomization. Clinical staff will not be blinded, however, to assignment.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Other: Linkage Navigation
* Other: Clinician Referral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ED patients who test positive for HCV antibodies ED patients who have discharged and confirmatory RNA result is positive Clinically stable per screening nurse or physician assessment Able to provide consent ED patients with untreated active HCV confirmed by the electronic medical record Exclusion Criteria: Younger than 18 years of age Prisoners Pregnant women Individuals that live out of state Unable to consent for care (e.g., altered mentation, critical illness or injury) Non English or Spanish speaking Have already participated in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinician Referral Only<br>The Clinician Referral arm will serve as an active control and baseline standard of care. All individuals who test positive for HCV antibodies or are identified with untreated, active HCV will be informed of their result and receive the following information from their clinical care teams in the ED: (a) explanation of process and rationale for follow-up RNA testing; (b) delivery of simple posttest counseling (e.g., risk for liver disease, risks of transmission); and (c) provision of a list of insurance enrollment resources, as needed, along with (d) a list of HCV treatment providers and their contact information as provided in aftercare instructions. For new HCV diagnoses, patients will be instructed to access their electronic patient portal (MyChart) for their RNA test results or to call a designated results line. Post-testing counseling messages and follow-up instructions will be included on the patient discharge papers. | Other: Clinician Referral<br>* The Clinician Referral arm will serve as an active control and baseline standard of care.<br>|
| Experimental: Clinician Referral + Linkage Navigation<br>The Linkage Navigation arm will consist of an additional service layered onto clinician referral and will incorporate protocols from Antiretroviral Treatment and Access Studies (ARTAS). Individuals randomized to this intervention will be contacted by a linkage navigator either during the ED visit (if during business hours) or the following business day (if during non-business hours). If the navigator does not contact the patient at the time of ED visit, they will offer to meet with the patient in person or over the phone. For all individuals in this arm, a structured linkage navigation process will include motivational interviewing and (a) reiteration of posttest counseling messages, (b) assessment of the patient's needs for medical insurance and substance abuse treatment, c) assistance scheduling and/or rescheduling appointments for HCV treatment, and d) follow-up phone call after the first HCV treatment appointment and thereafter as needed up to 6 months after ED visit. | Other: Linkage Navigation<br>* The Linkage Navigation arm will consist of an additional service layered onto clinician referral and will incorporate protocols from Antiretroviral Treatment and Access Studies (ARTAS), the most influential studies of HIV linkage-to-care to date.<br>Other: Clinician Referral<br>* The Clinician Referral arm will serve as an active control and baseline standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individuals who fill a prescription for Direct-Acting Antivirals (DAAs) for hepatitis C within 6 months of positive HCV RNA test (for new HCV diagnosis) or presenting at ED visit (for those identified with untreated, active HCV). | The primary outcome will be the number of individuals with positive HCV RNA test who initiate HCV treatment within 6 months from the time of ED diagnosis (for new HCV diagnoses) or from time of ED visit (for those identified with untreated, active HCV). This will be verified by electronic medical record review. | Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for those identified with untreated, active HCV). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individuals who attend an appointment with an HCV treatment provider within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses). | Measured by indication of a completed visit with an HCV treatment provider among those identified with active HCV. This will be verified by electronic medical record review. | Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses) |