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Completed

NCT Number: NCT04003454

The DETECT HCV Screening Trial

The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - "Screening Trial").

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Medical Center, Denver, Colorado, United States

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About this study

The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing electronic health records (EHRs) for each ED. Patients will therefore be offered HCV testing based on the result of the screening arm to which they are assigned, and in the case of the targeted arm, the results of the risk assessment evaluation performed by the intake nurse. All randomization will be completely integrated into electronic medical screening systems and workflow at each site. Integration of randomization into the electronic systems will allow for real-time concealed random allocation. Nurses who perform screening and all other ED staff (e.g. physicians, technicians) will understand the conceptual goals of the project but will be blinded to study hypotheses, and patients will be completely blinded to the purpose of the study.

This study will be performed at multiple sites, including the EDs at Denver Health Medical Center (DHMC) (Denver, Colorado), Johns Hopkins Hospital (JHH) (Baltimore, Maryland), and the University of Mississippi Medical Center (UMMC) (Jackson, Mississippi).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Present to EDs during study enrollment period
  • Clinically stable per screening nurse or physician assessment
  • Able to provide consent for medical care

Exclusion criteria

  • Younger than 18 years of age
  • Are unable to consent for care (i.e., altered mentation, critical illness, or injury)
  • Have already participated in the trial
  • Self-Identify as already living with HCV

Treatment and study plan

HCV Screening

Other

The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing EHRs for each ED.

Primary outcomes

  1. Newly diagnosed active HCV

    Time frame: 1 day from ED visit

    Confirmed cases of newly diagnosed active HCV, defined as patients who test positive for HCV antibody and measurable HCV RNA, and without a prior HCV diagnosis, stratified by study arm

Secondary outcomes

  1. HCV test acceptance

    Time frame: 1 day from ED visit

    Defined by the proportion of patients who agree to HCV testing, as measured by the proportion of those who consent among patients offered HCV testing, stratified by study arm

  2. HCV test completion

    Time frame: 1 day from ED visit

    Defined by the proportion of patients who complete HCV testing, as measured by the proportion of rapid HCV tests completed among patients who accepted testing, stratified by study arm

Other outcomes

  1. HCV genotype among those identified with active HCV

    Time frame: 12 months following HCV diagnosis

    Measured by HCV genotyping among those identified with active HCV

  2. Fibrosis staging

    Time frame: 12 months following HCV diagnosis

    Measured by standard of care fibrosis staging approaches (e.g. biopsy, ultrasound, FibroTest, etc.) among those identified with active HCV

  3. Completion of an evaluation by an HCV treatment expert

    Time frame: 12 months following HCV diagnosis

    Measured by indication of a completed visit with an HCV treatment expert among those identified with active HCV

  4. Initiation of treatment with Direct-Acting Antivirals (DAAs)

    Time frame: 12 months following HCV diagnosis

    Measured by indication of initiation of treatment with DAAs among those identified with active HCV

  5. Completion of treatment with Direct-Acting Antivirals (DAAs)

    Time frame: 12 months following HCV diagnosis

    Measured by indication of completion of treatment with DAAs among those identified with active HCV

  6. Sustained virologic response at 12 weeks after treatment completion (SVR12)

    Time frame: 12 months following HCV diagnosis

    Measured by undetectable HCV RNA 12 weeks after completion of DAAs among those identified with active HCV

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • Alameda County Medical Center
  • Boston Medical Center
  • Boston University
  • Johns Hopkins University
  • University of Cincinnati
  • University of Mississippi Medical Center

Registry information

Official study title

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

Acronym: DETECT HCV

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jul 1, 2019
Registry last updated
Feb 6, 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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