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NCT03767231 · ClinicalTrials.gov registry record · NA
ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing
A NA study, sponsored by Johns Hopkins University.
- Not yet
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT03767231: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT03767231 is a NA study that has not yet begun recruiting, run by Johns Hopkins University. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03767231, a NA study, has not yet begun recruiting, sponsored by Johns Hopkins University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
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
Interventions
- DIAGNOSTIC_TEST Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-11 |
| Est. Completion | 2027-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03767231
The ClinicalTrials.gov registry entry for NCT03767231 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) is the first listed.
NCT03767231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03767231 about?
NCT03767231 is a clinical study titled "ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing". 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 hepatocellu...
What is the current status of trial NCT03767231?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2026-11. Estimated completion is 2027-11.
What interventions are being tested in trial NCT03767231?
The interventions under investigation include: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03767231?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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