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The DETECT HCV Screening Trial (DETECT HCV)

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ClinicalTrials.gov Identifier: NCT04003454
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Collaborators:
Johns Hopkins University
University of Mississippi Medical Center
Boston University
Boston Medical Center
University of Cincinnati
Alameda County Medical Center
Information provided by (Responsible Party):
Jason Haukoos, Denver Health and Hospital Authority

Brief Summary:
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").

Condition or disease Intervention/treatment Phase
Hepatitis C Other: HCV Screening Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients presenting to the emergency department will be randomized to targeted HCV screening or nontargeted HCV screening
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Nontargeted Screening
The nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening.
Other: HCV Screening
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.

Targeted Screening
The targeted HCV screening arm will consist of implementation of risk-based rapid opt-out HCV screening using current recommendations for HCV screening by the CDC, USPSTF, and AASLD-IDSA. Targeted HCV screening will consist of offering HCV testing to those identified with the following specific risk characteristics, adapted from the above recommendations: born between 1945 - 1965 ("birth cohort"); injection drug use (IDU); intranasal drug use;tattoo or piercing in an unregulated setting; or blood transfusion or organ recipient before 1992.
Other: HCV Screening
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003454


Contacts
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Contact: Emily Caruso, MSPH 303-602-5178 Emily.Caruso@dhha.org
Contact: Alicia Cupelo, MSW, CCRP 303-602-7123 Alicia.Cupelo@dhha.org

Locations
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United States, Colorado
Denver Health Medical Center Not yet recruiting
Denver, Colorado, United States, 80204
Contact: Alicia K Cupelo, MSW, CCRP    303-602-7123    Alicia.Cupelo@dhha.org   
Contact: Emily Caruso, MSPH    303-602-5178    Emily.Caruso@dhha.org   
Principal Investigator: Jason Haukoos, MD, MSc         
Principal Investigator: Sarah Rowan, MD         
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Deanna Myer, CCRC    410-550-7907    Dmyer1@jhmi.edu   
Contact: Tiana Jones       tpurrin1@jhmi.edu   
Principal Investigator: Richard Rothman, MD, PhD         
Principal Investigator: Yu-Hsiang Hsieh, PhD         
United States, Mississippi
University of Mississippi Medical Center Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: Deepti Patki, MS    601-497-7944    dpatki@umc.edu   
Principal Investigator: James Galbraith, MD         
Sponsors and Collaborators
Denver Health and Hospital Authority
Johns Hopkins University
University of Mississippi Medical Center
Boston University
Boston Medical Center
University of Cincinnati
Alameda County Medical Center
Investigators
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Principal Investigator: Jason Haukoos, MD, MSc Denver Health
Principal Investigator: Sarah Rowan, MD Denver Health

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Responsible Party: Jason Haukoos, Professor & Director of Research, Department of Emergency Medicine, Denver Health, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT04003454     History of Changes
Other Study ID Numbers: R01DA042982 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason Haukoos, Denver Health and Hospital Authority:
Hepatitis C
Screening
Emergency Department
Risk

Additional relevant MeSH terms:
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Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections