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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 : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE December 5, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date March 11, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • 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 (1-5) with scores of 3 or higher indicating acceptability. There will be one question for this outcome.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03767231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing
Official Title  ICMJE Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing
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.

Detailed Description

Johns Hopkins Emergency Department-Based Rapid HCV Screening and Linkage to Care Program

Johns Hopkins Hospital Emergency Department (JHHED) has implemented an ED-based rapid HCV Screening and Linkage to Care Program since late 2015, after adapting the 2012 Centers for Disease Control and Prevention (CDC) revised HCV testing recommendations. The investigators' program utilizes an integrated, triage nurse driven model to deliver opt-out HCV testing to eligible ED patients. Eligibility was facilitated by electronic health record (EHR) prompts to identify patients over the age of 17 years and no HCV testing history at the institution. For patients who were medically/surgically stable and who did not have altered mental status, an opt-out HCV Ab test offering was delivered by staff. JHHED utilizes the blood-based anti-HCV assay (Abbott Architect) and fingerstick POC HCV assay (OraSure) for HCV Ab testing, depending on the availability of patient's whole blood drawn for his/her ED care. HCV reflex RNA testing is performed for HCV Ab reactive patients tested by blood-based HCV Ab assay. Blood specimens for HCV RNA testing are collected during the ED visit (if possible) for HCV Ab reactive patients tested by POC HCV Ab assay with confirmatory testing performed asynchronous to the ED visit. JHHED utilized dedicated linkage to care program staff that contacted ED patients with HCV Ab reactive results to deliver confirmatory results and facilitate referral to HCV care. The investigators' program staff also identify HCV Ab positive patients without HCV RNA viral load information by screening the ED tracking board (EPIC) to inform ED providers of ordering HCV RNA viral load testing which might need to have blood drawing if there is no blood work ordered in place.

Routine Care All JHHED patients are eligible for HCV screening or linkage to care service under the investigators' ED-based rapid HCV Screening and Linkage to Care Program if participants are 18 years and older, no history of HCV diagnosis or testing, and do not have altered mental status. Please see the brief description of the investigators' program above.

Recruitment A. Steps for recruiting participants with known HCV antibody positive but no HCV viral load data

  1. Research coordinator will first screen the ED tracking board (EPIC) for patients who potentially meet study enrollment criteria (i.e. not possessing any exclusion criteria), which is done routinely as part of the ED HCV Screening and Linkage to Care Program.
  2. Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study.
  3. Providers may refer eligible patients to research coordinator after getting permission from patients. Providers who are part of the investigators' study team will refer the eligible patients to research coordinator after patients agree to be approached by the investigators' research coordinator regarding the investigators' study.

For providers who are not in the investigators' study team, the recruitment procedure will be that the patient's clinician will request permission from patients and document in the chart regarding the patient's permission to be contacted by the research staff.

B. Steps for recruiting participants with newly diagnosed HCV antibody positive identified from ED HCV Screening and Linkage to Care Program

  1. Research coordinator will work closely with ED HCV Screening and Linkage to Care Program staff to recruit this subgroup of ED patients. Screening Program staff will notify the research coordinator via pager (or equivalent) when an ED patient is diagnosed with HCV Ab reactive result via the Screening Program.
  2. Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study.
  3. Providers may refer eligible patients to research coordinator after getting permission from patients. Providers who are part of the investigators' study team will refer the eligible patients to research coordinator after patients agree to be approached by the investigators' research coordinator regarding the study.

For providers who are not in the investigators' study team, the recruitment procedure will be that the patient's clinician will request permission from patients and document in the chart regarding the patient's permission to be contacted by the research staff.

Enrollment The research coordinator will obtain oral, informed consent. The process will involve a description of the study as provided in the verbal consent form with a chance to provide answers to any questions about the study. Justification for verbal consent is provided in the electronic Institutional Review Board (e-IRB) application. Specifically, this study poses minimal risk to patients. The consent process will take between approximately 15-20 minutes, based on the requirements of the individual patient.

Consented subjects will be given a copy of the oral consent document for participant's information and records. In this consent, the patient will be asked for permission to review patient's medical charts at Johns Hopkins Hospital for the clinical information of the ED visit and subsequent HCV-related visits. In addition, the patient will be asked for permission to allow the investigators to use the remnant blood specimen of this study in the future 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. Consented patients will be randomized to one of two groups, HCV POC Testing Group or Standard of Care (SOC) Group. The testing group will receive the POC HCV viral load testing via fingerstick using a novel Xpert HCV Viral Load Finger-stick (Xpert HCV VL FS) point-of-care (POC) test and the reference group will not receive this POC VL testing. Both groups will receive stand of care conventional laboratory-based whole blood HCV VL testing. Before the randomization, consented patients in both groups will 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. HCV POC Testing Group will fill out another short survey after POC viral load testing regarding participant's experience, attitudes, and perceptions regarding HCV POC viral load testing

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Hepatitis C
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deanna Myer 443-287-6985 dmyer1@jhmi.edu
Contact: Tiana Jones 410-735-6422 tpurrin1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03767231
Other Study ID Numbers  ICMJE IRB00171078
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yu-Hsiang Hsieh, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP