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Rapid HCV Test for Hepatitis C

N/A

Waitlist Available

Led By Yu-Hsiang Hsieh, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patient who has a diagnosis of chronic HCV infection

Patient with a chief complaint of sexual assault

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new, rapid HCV viral load test to see if it is accurate and acceptable to patients in the emergency department.

Who is the study for?

This trial is for adult patients (18-100 years old) at Johns Hopkins Emergency Department who have tested positive for HCV antibodies but don't yet have an HCV RNA test result. It's not open to those with severe illness, altered mental status, refugees, minors, chronic HCV diagnosis, non-reactive HCV Ab test results, sexual assault victims, incarcerated individuals, sex workers, previous enrollees in this study, pregnant women or transgender persons.

What is being tested?

The trial is testing the acceptability of a new point-of-care Hepatitis C viral load test that gives results within an hour from a finger-stick sample. Participants will be randomly assigned to either receive this new rapid test or the standard lab-based viral load testing which takes 1-2 days for results.

What are the potential side effects?

Since the intervention involves only diagnostic testing and not treatment medication there are no direct side effects related to drugs; however minor risks may include discomfort or bruising from the finger-stick blood collection.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with chronic hepatitis C.

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I am seeking help following a sexual assault.

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I identify as transgender.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of POC HCV viral load testing as assessed by a Likert scale

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

Secondary study objectives

Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by sensitivity of the assay

Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by specificity of the assay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HCV POC VL GroupExperimental Treatment1 Intervention

This group will receive the POC HCV viral load testing via fingerstick using the novel Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Participants in this group will also fill out a short survey regarding participant's socio-demographic information as well as participant's experience, attitudes, and perceptions regarding HCV testing and care.

Group II: Reference GroupActive Control1 Intervention

This group will receive the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing only. Participants in this group will also fill out a short survey regarding participant's socio-demographic information as well as participant's experience, attitudes, and perceptions regarding HCV testing and care.

0 / 4Eligibility criteria met