The DETECT HCV Linkage to Care Trial

Denver Health and Hospital Authority

Status: Active, not recruiting

Conditions: Hepatitis C

Treatments: Other: Linkage Navigation; Other: Clinician Referral

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04026867

R01DA042982

17-2327

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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309 participants in 2 patient groups

Clinician Referral Only

Active Comparator group

Description:

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.

Treatment:

Other: Clinician Referral

Clinician Referral + Linkage Navigation

Experimental group

Description:

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.

Treatment:

Other: Clinician Referral

Other: Linkage Navigation