Understanding Patient Views on Rapid Hepatitis C Testing

This study is looking at how patients in the emergency department (ED) feel about a new, rapid test for Hepatitis C (HCV) called the Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid). Hepatitis C is a serious liver infection, and many people don't know they have it. This study wants to see if this quick finger-stick test is acceptable to patients and if it helps more people get connected to care for their Hepatitis C. You might be able to join if you are an adult (18-100 years old) at Johns Hopkins Emergency Department, have tested positive for HCV antibodies, but haven't had a follow-up test to confirm the active virus. The study aims to enroll 200 participants.

Study design
This is an interventional study that will randomly assign 200 participants to either receive the Xpert HCV Viral Load Finger-stick Point-of-Care test or be in a reference group.
What's involved
You will take a short survey about Hepatitis C care and treatment at the time of enrollment, which should take up to 15 minutes.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to see how many are linked to care for Hepatitis C.

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NCT03767231

ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing

Not Yet Recruiting
NAAges 18+InterventionalHealth services
Johns Hopkins University
~200 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of POC HCV viral load testing as assessed by a Likert scale
Measured over At the time of enrollment, up to 15 minutes
+1 more outcome measured
Hepatitis C
1 sites across 1 states
Maryland1
  • Yu-Hsiang Hsieh, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Eligibility criteria

Inclusion

Any Johns Hopkins Emergency Department patient who has HCV antibody positive result but no HCV RNA test result in the chart
Able to provide informed consent
18-100 years

Exclusion

Patient who has a diagnosis of chronic HCV infection
Patient with a non-reactive test result of an HCV Ab screening test
Patient with a chief complaint of sexual assault
Patients who are otherwise ineligible to consent due to medical condition (e.g., severe illness, altered mental status)
Any person who has previously enrolled in this study
Any person less than 18 years of age
Any person who is incarcerated
Any woman who is pregnant
Any person who is transgender
Any person who is sex worker
Any person who is refugee
  • Acceptability of POC HCV viral load testing as assessed by a Likert scaleAt the time of enrollment, up to 15 minutes

    The acceptability will be assessed using the 5-point Likert Scale (1-5) with scores of 3 or higher indicating acceptability. There will be one question for this outcome.

  • Linkage to care rates between the HCV POC VL group and the control group12 months

    Percentage of patients who receive standard of care HCV viral load testing entering care for HCV and percentage of patients who receive POC HCV viral load testing in the ED entering care for HCV will be calculated and used in the assessment of linkage to care rate.