Rapid HCV Test for Hepatitis C

Overseen By Gaby Dashler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Chronic HCV, Pregnancy, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Xpert HCV Viral Load Finger-stick Point-of-Care test, which quickly identifies active hepatitis C infection. The researchers seek to determine the usefulness and acceptability of this rapid test compared to the standard blood test, which takes longer to deliver results. Individuals who have tested positive for hepatitis C antibodies but lack current viral load information are well-suited for this trial. Participants will receive either the new rapid finger-stick test or the regular blood test to assess which method better facilitates care after an emergency department visit. As an unphased trial, this study offers participants the chance to contribute to research that could enhance rapid testing methods for hepatitis C.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this point-of-care test is safe for detecting HCV?

Research has shown that the Xpert HCV Viral Load Finger-stick Point-of-Care test is safe for people. A study in Australia demonstrated that this test accurately detected active Hepatitis C infections with 100% accuracy, correctly identifying all cases of the virus without errors.

The test is straightforward: it uses a quick finger-stick to collect a small blood sample and provides results in about an hour. This rapid process allows for a quick diagnosis in just one visit, without requiring complicated equipment or long waiting times.

Additionally, the FDA has approved the test, indicating trust in its safety and effectiveness. Although the test is new, current data supports its safety for people, making it a promising choice for those needing a quick and accurate Hepatitis C diagnosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Xpert HCV Viral Load Finger-stick Point-of-Care test because it offers a quick and convenient alternative to the traditional blood draw and lab testing methods currently used for Hepatitis C. Unlike the standard of care, which requires whole-blood samples to be sent to a lab, this test can be done right on the spot with just a finger-stick, providing rapid results. This method not only simplifies the testing process but also improves patient experience by being less invasive and more accessible, especially in resource-limited settings.

What evidence suggests that the Xpert HCV Viral Load Finger-stick Point-of-Care test is effective for detecting HCV?

Research has shown that the Xpert HCV Viral Load Finger-stick test, administered to participants in the HCV POC VL Group of this trial, effectively detects Hepatitis C. Studies have found this test to be 100% accurate, correctly identifying all individuals with and without the infection. It uses a small blood sample from a finger-stick and delivers results in about an hour. This quick and accurate test can enhance access to Hepatitis C diagnosis and treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Yu-Hsiang Hsieh, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to provide informed consent

Any Johns Hopkins Emergency Department patient who has HCV antibody positive result but no HCV RNA test result in the chart

Exclusion Criteria

You are pregnant.

I have been diagnosed with chronic hepatitis C.

I am seeking help following a sexual assault.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Enrollment and Randomization

Eligible participants are enrolled and randomized into either the POC Testing Group or Standard of Care Group

1 day

1 visit (in-person)

Testing and Survey

Participants receive either the POC HCV viral load testing or standard-of-care testing and complete a survey on HCV care and treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for linkage to care and accuracy of the POC HCV viral load testing

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)

Trial Overview 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.

How Is the Trial Designed?

Group I: HCV POC VL Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Cepheid

Industry Sponsor

Trials

24

Recruited

10,500+

Citations

1. cepheid.com cepheid.com/en-CY/tests/blood-virology-womens-health-sexual-health/xpert-hcv-vl-fingerstick.html

Xpert® HCV VL Fingerstick The point-of-care test simplifies diagnosis of Hepatitis C infections by providing patients with viral load results in a single visit in less than an hour ...

2. cepheid.com cepheid.com/en-US/tests/blood-virology-womens-health-sexual-health/xpert-hcv-info.html

Xpert® HCV Info This simple to use test detects the full range of relevant HCV genotypes in about an hour and can be performed on a small volume of blood collected via ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7079170/

In‐field evaluation of Xpert® HCV viral load Fingerstick assay ... What is required from HCV point‐of‐care tests to reduce the burden of hepatitis C infection? 'Development and clinical validation of the genedrive point‐of ...

4. academic.oup.com academic.oup.com/jid/article/217/12/1889/4925218

Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of ... The Xpert HCV VL FS test can accurately detect active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis. testing, diagnostics, ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824534

Feasibility and Performance of a Point-of-Care Hepatitis C ... This cross-sectional study examines the feasibility and clinical performance of a fingerstick point-of-care hepatitis C virus (HCV) RNA ...

6. cepheid.com cepheid.com/en-US/tests/blood-virology-womens-health-sexual-health/xpert-hcv.html

Xpert HCV The Xpert HCV test utilizes an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) to qualitatively detect hepatitis C virus (HCV) RNA.

7. fda.gov fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test

FDA Permits Marketing of First Point-of-Care Hepatitis C ... The US Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus ...