The DETECT HCV Screening Trial

Hepatitis C Clinical Trial

— DETECT HCV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04003454
• Other study ID #: R01DA042982
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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").

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 147533
• Est. completion date: January 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Denver Health Medical Center	Denver	Colorado
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (7)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Alameda County Medical Center, Boston Medical Center, Boston University, Johns Hopkins University, University of Cincinnati, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HCV genotype among those identified with active HCV	Measured by HCV genotyping among those identified with active HCV	12 months following HCV diagnosis
Other	Fibrosis staging	Measured by standard of care fibrosis staging approaches (e.g. biopsy, ultrasound, FibroTest, etc.) among those identified with active HCV	12 months following HCV diagnosis
Other	Completion of an evaluation by an HCV treatment expert	Measured by indication of a completed visit with an HCV treatment expert among those identified with active HCV	12 months following HCV diagnosis
Other	Initiation of treatment with Direct-Acting Antivirals (DAAs)	Measured by indication of initiation of treatment with DAAs among those identified with active HCV	12 months following HCV diagnosis
Other	Completion of treatment with Direct-Acting Antivirals (DAAs)	Measured by indication of completion of treatment with DAAs among those identified with active HCV	12 months following HCV diagnosis
Other	Sustained virologic response at 12 weeks after treatment completion (SVR12)	Measured by undetectable HCV RNA 12 weeks after completion of DAAs among those identified with active HCV	12 months following HCV diagnosis
Primary	Newly diagnosed active HCV	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	1 day from ED visit
Secondary	HCV test acceptance	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	1 day from ED visit
Secondary	HCV test completion	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	1 day from ED visit