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

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ClinicalTrials.gov Identifier: NCT03767231
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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 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 before randomization. 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. A short survey will be conducted just for the POC Testing Group after participants receive the test result of the novel assay. 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 an in-house HCV RNA viral load assay developed by Dr. Tza-Huei Wang's group at Institute for NanoBioTechnology, The Johns Hopkins University.


Condition or disease Intervention/treatment Phase
Hepatitis C Viral Load Testing Point of Care Diagnostic Test: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HCV POC VL Group
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 prior to the randomization regarding participant's socio-demographic information as well as participant's experience, attitudes, and perceptions regarding HCV testing and care. A second short survey will be conducted just for the HCV POC VL Group after participants receive the test result of the novel assay.
Diagnostic Test: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
The investigators will randomly assign eligible and consented patients to either to HCV POC VL Group or Reference Group. All participants will take a short survey regarding HCV care and treatment before randomization. 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 HCV POC VL 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 1 to 1½ hours of the testing. A second short survey will be conducted just for the HCV POC VL Group after participants receive the test result of the novel assay.

No Intervention: Reference Group
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 prior to the randomization regarding participant's socio-demographic information as well as participant's experience, attitudes, and perceptions regarding HCV testing and care.



Primary Outcome Measures :
  1. Acceptability of POC HCV viral load testing as assessed by a likert scale [ Time Frame: At the time of enrollment, up to 15 minutes ]
    The acceptability will be assessed using the 5-point Likert Scale with higher scores indicating acceptability.

  2. Linkage to care rates between the HCV POC VL group and the control group [ Time Frame: 12 months ]
    Percentage of patients who receive standard of care HCV viral load testing entering care for HCV and percentage of patients who receive POC HCV viral load testing in the ED entering care for HCV will be calculated and used in the assessment of linkage to care rate.


Secondary Outcome Measures :
  1. Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by sensitivity of the assay [ Time Frame: 12 months ]
    Sensitivity of the in-house POC HCV viral load assay will be determined by the proportion of true positives that are identified as such by the assay.

  2. Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by specificity of the assay [ Time Frame: 12 months ]
    Specificity of the in-house POC HCV viral load assay will be determined by the proportion of true negatives that are identified as such by the assay.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767231


Contacts
Contact: Deanna Myer 443-287-6985 dmyer1@jhmi.edu
Contact: Tiana Jones 410-735-6422 tpurrin1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Deanna Myer    443-287-6985    dmyer1@jhmi.edu   
Contact: Tiana Jones    410-735-6422    tpurrin1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Yu-Hsiang Hsieh, PhD Johns Hopkins University

Additional Information:
Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03767231     History of Changes
Other Study ID Numbers: IRB00171078
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections