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

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the site
Trial code
Status
Not yet recruiting
People taking part
200 people, planned
Started
Nov 2026
Expected to end
Nov 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
Record updated
10 November 2025

Who can take part

Age
18 years to 100 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any person who has previously enrolled in this study
  • Patient who has a diagnosis of chronic HCV infection
  • Patient with a non-reactive test result of an HCV Ab screening test
  • Patients who are otherwise ineligible to consent due to medical condition (e.g., severe illness, altered mental status)
  • Any person less than 18 years of age
  • Patient with a chief complaint of sexual assault
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in United States

  • Johns Hopkins UniversityBaltimore, United StatesContact: Gaby DashlerNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • HCV POC VL GroupTreatment being tested

    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.

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

  • Reference GroupNo study treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing
Fit questions
Built from NCT03767231, who can take part
Record updated
10 November 2025