The DETECT HCV Screening Trial

Denver Health and Hospital Authority

Status: Completed

Conditions: Hepatitis C

Treatments: Other: HCV Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04003454

R01DA042982

Details and patient eligibility

About

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").

Full 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).

Enrollment: 147,533 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147,533 participants in 2 patient groups

Nontargeted Screening

Other group

Description:

The nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening.

Treatment:

Other: HCV Screening

Targeted Screening

Other group

Description:

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.

Treatment:

Other: HCV Screening