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Completed

NCT Number: NCT04026867

The DETECT HCV Linkage to Care Trial

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linkage Navigation

Other

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.

Clinician Referral

Other

The Clinician Referral arm will serve as an "active control" and baseline standard of care.

Primary outcomes

  1. 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).

    Time frame: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or 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.

Secondary outcomes

  1. 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).

    Time frame: Within 6 months from time of HCV diagnosis (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.

Other outcomes

  1. For individuals who self-identify as a person who injects drugs (PWID), the number of individuals who initiate substance use disorder services within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

    Time frame: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

    Measured by indication of a completed visit with a substance use treatment provider. This will be verified via electronic medical record review.

  2. Number of individuals who complete their full course of HCV treatment with DAAs within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

    Time frame: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

    Measured by indication of completion of treatment with DAAs among those individuals identified with active HCV. This will be verified by electronic medical record review.

  3. Number of individuals who have documented sustained virologic response 12 weeks after completing treatment with DAAs within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

    Time frame: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

    Rates of sustained virologic response within 12 weeks (SVR12) will be measured by report of undetectable HCV RNA Nucleic Acid Amplification Test (NAAT) 12 weeks after completion of DAAs among those identified with active HCV. This will be verified by electronic medical record review.

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: DETECT HCV

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2019
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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