Rapid HCV Test for Hepatitis C
Trial Summary
What is the purpose of this trial?
Hepatitis C virus (HCV) infection has become the leading fatal infectious disease in the United States. Approximately 75% of individuals who have been infected with HCV are chronically infected with the virus. Untreated chronic infection will lead to severe sequelae such as cirrhosis and hepatocellular carcinoma. Even though the availability of rapid HCV antibody (HCV Ab) screening assay and highly effective antiviral treatment, most people infected with HCV are not aware of the infection status. This gap mainly comes from the current gold standard confirmatory testing for chronic HCV infection, the Polymerase Chain Reaction (PCR)-based HCV RNA viral load assay which requires an experienced trained laboratory technician to perform relatively complicated PCR assay with a turn-around-time of 1 to 2 days (from provider's order to the test resulting). The investigators' rapid HCV Screening and Linkage to Care program has demonstrated that many patients in the investigators' emergency department (ED) are unaware of patient's chronic HCV infection status due to the barriers to receive the gold standard viral load testing. Recently, a novel Xpert HCV Viral Load (VL) Finger-stick (FS) \[Xpert HCV VL FS\] point-of-care (POC) test (Cepheid) has been developed. In an observational cohort in Australia, HCV RNA was detected in 40% of participants (85 of 210) enrolled at 3 drug treatment clinics and 1 homelessness service. Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in samples collected by finger-stick was 100.0% (95% Confidence Interval (CI), 93.9%-100.0%) and specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis. In this protocol, the investigators seek to determine the needs and acceptability of a novel POC HCV viral load testing assay among ED HCV Ab positive patients. For this project, the investigators will identify and enroll ED patients with HCV Ab positive but without HCV viral information. The investigators will conduct a randomized study to assign eligible and consented patients to either to POC Testing Group or Standard of Care (SOC) Group. All participants will take a short survey regarding HCV care and treatment. As part of the investigators' ED HCV Screening and Linkage to Care Program, all participants will receive the standard-of-care clinical laboratory-based HCV RNA viral load testing via whole blood (i.e. patient will receive blood drawn). This standard-of-care HCV viral load testing result will be provided to participant when it is available (usually 1-2 days later). Participants in the POC Testing Group will receive the novel POC HCV RNA viral load testing and the result of the novel test will be disclosed to the patients approximately within 2 hours of the testing. Linkage to care information after the ED visit will be compared between two groups. Finally, accuracy of this POC HCV RNA viral load testing in the acute care setting will be determined as compared to the standard-of-care clinical laboratory-based HCV RNA viral load testing. The investigators will also ask all of participants to grant permission to use the remnant blood specimens for an evaluation of future in-house HCV RNA viral load assay.
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 data supports the effectiveness of the Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) for diagnosing and monitoring Hepatitis C?
The Xpert HCV Viral Load Finger-stick test is shown to be highly effective, with a sensitivity of 100% and specificity of 98.4% when compared to a standard laboratory test. It provides rapid results, making it a reliable method for diagnosing and monitoring Hepatitis C, especially in settings where quick and easy testing is needed.12345
Is the Xpert HCV Viral Load Finger-stick Point-of-Care test safe for humans?
How does the Xpert HCV Viral Load Fingerstick test differ from other treatments for Hepatitis C?
The Xpert HCV Viral Load Fingerstick test is unique because it allows for rapid, point-of-care testing of Hepatitis C virus RNA using a simple fingerstick blood sample, providing results in about 60 minutes. This is different from traditional methods that require venous blood samples and longer processing times, making it particularly useful for patients with difficult venous access and in decentralized settings.12347
Research Team
Yu-Hsiang Hsieh, PhD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Randomization
Eligible participants are enrolled and randomized into either the POC Testing Group or Standard of Care Group
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
Follow-up
Participants are monitored for linkage to care and accuracy of the POC HCV viral load testing
Treatment Details
Interventions
- Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
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Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Cepheid
Industry Sponsor