<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767231</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00171078</org_study_id>
    <nct_id>NCT03767231</nct_id>
  </id_info>
  <brief_title>ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing</brief_title>
  <official_title>Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hepatitis C virus (HCV) infection has become the leading fatal infectious disease in the&#xD;
      United States. Approximately 75% of individuals who have been infected with HCV are&#xD;
      chronically infected with the virus. Untreated chronic infection will lead to severe sequelae&#xD;
      such as cirrhosis and hepatocellular carcinoma. Even though the availability of rapid HCV&#xD;
      antibody (HCV Ab) screening assay and highly effective antiviral treatment, most people&#xD;
      infected with HCV are not aware of the infection status. This gap mainly comes from the&#xD;
      current gold standard confirmatory testing for chronic HCV infection, the Polymerase Chain&#xD;
      Reaction (PCR)-based HCV RNA viral load assay which requires an experienced trained&#xD;
      laboratory technician to perform relatively complicated PCR assay with a turn-around-time of&#xD;
      1 to 2 days (from provider's order to the test resulting). The investigators' rapid HCV&#xD;
      Screening and Linkage to Care program has demonstrated that many patients in the&#xD;
      investigators' emergency department (ED) are unaware of patient's chronic HCV infection&#xD;
      status due to the barriers to receive the gold standard viral load testing.&#xD;
&#xD;
      Recently, a novel Xpert HCV Viral Load (VL) Finger-stick (FS) [Xpert HCV VL FS] point-of-care&#xD;
      (POC) test (Cepheid) has been developed. In an observational cohort in Australia, HCV RNA was&#xD;
      detected in 40% of participants (85 of 210) enrolled at 3 drug treatment clinics and 1&#xD;
      homelessness service. Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in&#xD;
      samples collected by finger-stick was 100.0% (95% Confidence Interval (CI), 93.9%-100.0%) and&#xD;
      specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect&#xD;
      active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis.&#xD;
&#xD;
      In this protocol, the investigators seek to determine the needs and acceptability of a novel&#xD;
      POC HCV viral load testing assay among ED HCV Ab positive patients. For this project, the&#xD;
      investigators will identify and enroll ED patients with HCV Ab positive but without HCV viral&#xD;
      information. The investigators will conduct a randomized study to assign eligible and&#xD;
      consented patients to either to POC Testing Group or Standard of Care (SOC) Group. All&#xD;
      participants will take a short survey regarding HCV care and treatment. As part of the&#xD;
      investigators' ED HCV Screening and Linkage to Care Program, all participants will receive&#xD;
      the standard-of-care clinical laboratory-based HCV RNA viral load testing via whole blood&#xD;
      (i.e. patient will receive blood drawn). This standard-of-care HCV viral load testing result&#xD;
      will be provided to participant when it is available (usually 1-2 days later). Participants&#xD;
      in the POC Testing Group will receive the novel POC HCV RNA viral load testing and the result&#xD;
      of the novel test will be disclosed to the patients approximately within 2 hours of the&#xD;
      testing. Linkage to care information after the ED visit will be compared between two groups.&#xD;
      Finally, accuracy of this POC HCV RNA viral load testing in the acute care setting will be&#xD;
      determined as compared to the standard-of-care clinical laboratory-based HCV RNA viral load&#xD;
      testing. The investigators will also ask all of participants to grant permission to use the&#xD;
      remnant blood specimens for an evaluation of future in-house HCV RNA viral load assay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Johns Hopkins Emergency Department-Based Rapid HCV Screening and Linkage to Care Program&#xD;
&#xD;
      Johns Hopkins Hospital Emergency Department (JHHED) has implemented an ED-based rapid HCV&#xD;
      Screening and Linkage to Care Program since late 2015, after adapting the 2012 Centers for&#xD;
      Disease Control and Prevention (CDC) revised HCV testing recommendations. The investigators'&#xD;
      program utilizes an integrated, triage nurse driven model to deliver opt-out HCV testing to&#xD;
      eligible ED patients. Eligibility was facilitated by electronic health record (EHR) prompts&#xD;
      to identify patients over the age of 17 years and no HCV testing history at the institution.&#xD;
      For patients who were medically/surgically stable and who did not have altered mental status,&#xD;
      an opt-out HCV Ab test offering was delivered by staff. JHHED utilizes the blood-based&#xD;
      anti-HCV assay (Abbott Architect) and fingerstick POC HCV assay (OraSure) for HCV Ab testing,&#xD;
      depending on the availability of patient's whole blood drawn for his/her ED care. HCV reflex&#xD;
      RNA testing is performed for HCV Ab reactive patients tested by blood-based HCV Ab assay.&#xD;
      Blood specimens for HCV RNA testing are collected during the ED visit (if possible) for HCV&#xD;
      Ab reactive patients tested by POC HCV Ab assay with confirmatory testing performed&#xD;
      asynchronous to the ED visit. JHHED utilized dedicated linkage to care program staff that&#xD;
      contacted ED patients with HCV Ab reactive results to deliver confirmatory results and&#xD;
      facilitate referral to HCV care. The investigators' program staff also identify HCV Ab&#xD;
      positive patients without HCV RNA viral load information by screening the ED tracking board&#xD;
      (EPIC) to inform ED providers of ordering HCV RNA viral load testing which might need to have&#xD;
      blood drawing if there is no blood work ordered in place.&#xD;
&#xD;
      Routine Care All JHHED patients are eligible for HCV screening or linkage to care service&#xD;
      under the investigators' ED-based rapid HCV Screening and Linkage to Care Program if&#xD;
      participants are 18 years and older, no history of HCV diagnosis or testing, and do not have&#xD;
      altered mental status. Please see the brief description of the investigators' program above.&#xD;
&#xD;
      Recruitment A. Steps for recruiting participants with known HCV antibody positive but no HCV&#xD;
      viral load data&#xD;
&#xD;
        1. The ED HCV Screening and Linkage to Care (LTC) Program will screen the ED tracking board&#xD;
           (EPIC) for patients who potentially meet study enrollment criteria (i.e. not possessing&#xD;
           any exclusion criteria), which is done routinely as a part of standard of care. The ED&#xD;
           HCV Screening and LTC team will notify the research coordinator of all eligible&#xD;
           patients.&#xD;
&#xD;
        2. Research coordinator will then approach the treating ED clinician for his/her patients&#xD;
           regarding the research opportunity in the investigators' study.&#xD;
&#xD;
        3. Providers may refer eligible patients to research coordinator after getting permission&#xD;
           from patients. Providers who are part of the investigators' study team will refer the&#xD;
           eligible patients to research coordinator after patients agree to be approached by the&#xD;
           investigators' research coordinator regarding the investigators' study.&#xD;
&#xD;
      For providers who are not in the investigators' study team, the recruitment procedure will be&#xD;
      that the patient's clinician will request permission from patients and document in the chart&#xD;
      regarding the patient's permission to be contacted by the research staff.&#xD;
&#xD;
      B. Steps for recruiting participants with newly diagnosed HCV antibody positive identified&#xD;
      from ED HCV Screening and Linkage to Care Program&#xD;
&#xD;
        1. Research coordinator will work closely with ED HCV Screening and Linkage to Care Program&#xD;
           staff to recruit this subgroup of ED patients. Screening Program staff will notify the&#xD;
           research coordinator via pager (or equivalent) when an ED patient is diagnosed with HCV&#xD;
           Ab reactive result via the Screening Program.&#xD;
&#xD;
        2. Research coordinator will then approach the treating ED clinician for his/her patients&#xD;
           regarding the research opportunity in the investigators' study.&#xD;
&#xD;
        3. Providers may refer eligible patients to research coordinator after getting permission&#xD;
           from patients. Providers who are part of the investigators' study team will refer the&#xD;
           eligible patients to research coordinator after patients agree to be approached by the&#xD;
           investigators' research coordinator regarding the study.&#xD;
&#xD;
      For providers who are not in the investigators' study team, the recruitment procedure will be&#xD;
      that the patient's clinician will request permission from patients and document in the chart&#xD;
      regarding the patient's permission to be contacted by the research staff.&#xD;
&#xD;
      Enrollment The research coordinator will obtain oral, informed consent. The process will&#xD;
      involve a description of the study as provided in the verbal consent form with a chance to&#xD;
      provide answers to any questions about the study. Justification for verbal consent is&#xD;
      provided in the electronic Institutional Review Board (e-IRB) application. Specifically, this&#xD;
      study poses minimal risk to patients. The consent process will take between approximately&#xD;
      15-20 minutes, based on the requirements of the individual patient.&#xD;
&#xD;
      Consented subjects will be given a copy of the oral consent document for participant's&#xD;
      information and records. In this consent, the patient will be asked for permission to review&#xD;
      patient's medical charts at Johns Hopkins Hospital for the clinical information of the ED&#xD;
      visit and subsequent HCV-related visits. In addition, the patient will be asked for&#xD;
      permission to allow the investigators to use the remnant blood specimen of this study in the&#xD;
      future for an evaluation of an in-house HCV RNA viral load assay. Consented patients will be&#xD;
      randomized to one of two groups, HCV POC Testing Group or Standard of Care (SOC) Group. The&#xD;
      testing group will receive the POC HCV viral load testing via fingerstick using a novel Xpert&#xD;
      HCV Viral Load Finger-stick (Xpert HCV VL FS) point-of-care (POC) test and the reference&#xD;
      group will not receive this POC VL testing. Both groups will receive stand of care&#xD;
      conventional laboratory-based whole blood HCV VL testing. Consented patients in both groups&#xD;
      will fill out a short survey regarding participant's socio-demographic information as well as&#xD;
      participant's experience, attitudes, and perceptions regarding HCV testing and care&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2023</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of POC HCV viral load testing as assessed by a Likert scale</measure>
    <time_frame>At the time of enrollment, up to 15 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Linkage to care rates between the HCV POC VL group and the control group</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by sensitivity of the assay</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by specificity of the assay</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>HCV POC VL Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)</intervention_name>
    <description>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. 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.</description>
    <arm_group_label>HCV POC VL Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any Johns Hopkins Emergency Department patient who has HCV antibody positive result&#xD;
             but no HCV RNA test result in the chart&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  18-100 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who has a diagnosis of chronic HCV infection&#xD;
&#xD;
          -  Patient with a non-reactive test result of an HCV Ab screening test&#xD;
&#xD;
          -  Patient with a chief complaint of sexual assault&#xD;
&#xD;
          -  Patients who are otherwise ineligible to consent due to medical condition (e.g.,&#xD;
             severe illness, altered mental status)&#xD;
&#xD;
          -  Any person who has previously enrolled in this study&#xD;
&#xD;
          -  Any person less than 18 years of age&#xD;
&#xD;
          -  Any person who is incarcerated&#xD;
&#xD;
          -  Any woman who is pregnant&#xD;
&#xD;
          -  Any person who is transgender&#xD;
&#xD;
          -  Any person who is sex worker&#xD;
&#xD;
          -  Any person who is refugee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Hsiang Hsieh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deanna Myer</last_name>
    <phone>443-287-6985</phone>
    <email>dmyer1@jhmi.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tiana Jones</last_name>
    <phone>410-735-6422</phone>
    <email>tpurrin1@jhmi.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Deanna Myer</last_name>
      <phone>443-287-6985</phone>
      <email>dmyer1@jhmi.edu</email>
    </contact>
    <contact_backup>
      <last_name>Tiana Jones</last_name>
      <phone>410-735-6422</phone>
      <email>tpurrin1@jhmi.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.who.int/mediacentre/factsheets/fs164/en/</url>
    <description>Hepatitis C - Fact Sheet. World Health Organization, 2017.</description>
  </link>
  <reference>
    <citation>Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, Jewett A, Baack B, Rein DB, Patel N, Alter M, Yartel A, Ward JW; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012 Aug 17;61(RR-4):1-32. Erratum In: MMWR Recomm Rep. 2012 Nov 2;61(43):886.</citation>
    <PMID>22895429</PMID>
  </reference>
  <reference>
    <citation>Grebely J, Applegate TL, Cunningham P, Feld JJ. Hepatitis C point-of-care diagnostics: in search of a single visit diagnosis. Expert Rev Mol Diagn. 2017 Dec;17(12):1109-1115. doi: 10.1080/14737159.2017.1400385. Epub 2017 Nov 8.</citation>
    <PMID>29088981</PMID>
  </reference>
  <reference>
    <citation>Rein DB, Wittenborn JS, Weinbaum CM, Sabin M, Smith BD, Lesesne SB. Forecasting the morbidity and mortality associated with prevalent cases of pre-cirrhotic chronic hepatitis C in the United States. Dig Liver Dis. 2011 Jan;43(1):66-72. doi: 10.1016/j.dld.2010.05.006. Epub 2010 Jun 17.</citation>
    <PMID>20739252</PMID>
  </reference>
  <reference>
    <citation>Brillman JC, Crandall CS, Florence CS, Jacobs JL. Prevalence and risk factors associated with hepatitis C in ED patients. Am J Emerg Med. 2002 Sep;20(5):476-80. doi: 10.1053/ajem.2002.32642.</citation>
    <PMID>12216048</PMID>
  </reference>
  <reference>
    <citation>Galbraith JW, Franco RA, Donnelly JP, Rodgers JB, Morgan JM, Viles AF, Overton ET, Saag MS, Wang HE. Unrecognized chronic hepatitis C virus infection among baby boomers in the emergency department. Hepatology. 2015 Mar;61(3):776-82. doi: 10.1002/hep.27410. Epub 2015 Jan 28.</citation>
    <PMID>25179527</PMID>
  </reference>
  <reference>
    <citation>Hsieh YH, Rothman RE, Laeyendecker OB, Kelen GD, Avornu A, Patel EU, Kim J, Irvin R, Thomas DL, Quinn TC. Evaluation of the Centers for Disease Control and Prevention Recommendations for Hepatitis C Virus Testing in an Urban Emergency Department. Clin Infect Dis. 2016 May 1;62(9):1059-65. doi: 10.1093/cid/ciw074. Epub 2016 Feb 21.</citation>
    <PMID>26908800</PMID>
  </reference>
  <reference>
    <citation>Kelen GD, Green GB, Purcell RH, Chan DW, Qaqish BF, Sivertson KT, Quinn TC. Hepatitis B and hepatitis C in emergency department patients. N Engl J Med. 1992 May 21;326(21):1399-404. doi: 10.1056/NEJM199205213262105.</citation>
    <PMID>1373867</PMID>
  </reference>
  <reference>
    <citation>Lyons MS, Kunnathur VA, Rouster SD, Hart KW, Sperling MI, Fichtenbaum CJ, Sherman KE. Prevalence of Diagnosed and Undiagnosed Hepatitis C in a Midwestern Urban Emergency Department. Clin Infect Dis. 2016 May 1;62(9):1066-71. doi: 10.1093/cid/ciw073. Epub 2016 Feb 21.</citation>
    <PMID>26908799</PMID>
  </reference>
  <reference>
    <citation>Anderson ES, Galbraith JW, Deering LJ, Pfeil SK, Todorovic T, Rodgers JB, Forsythe JM, Franco R, Wang H, Wang NE, White DAE. Continuum of Care for Hepatitis C Virus Among Patients Diagnosed in the Emergency Department Setting. Clin Infect Dis. 2017 Jun 1;64(11):1540-1546. doi: 10.1093/cid/cix163. Erratum In: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433.</citation>
    <PMID>28207069</PMID>
  </reference>
  <reference>
    <citation>McHugh MP, Wu AHB, Chevaliez S, Pawlotsky JM, Hallin M, Templeton KE. Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay. J Clin Microbiol. 2017 May;55(5):1550-1556. doi: 10.1128/JCM.02460-16. Epub 2017 Mar 8.</citation>
    <PMID>28275079</PMID>
  </reference>
  <reference>
    <citation>Pinsky BA, Sahoo MK, Sandlund J, Kleman M, Kulkarni M, Grufman P, Nygren M, Kwiatkowski R, Baron EJ, Tenover F, Denison B, Higuchi R, Van Atta R, Beer NR, Carrillo AC, Naraghi-Arani P, Mire CE, Ranadheera C, Grolla A, Lagerqvist N, Persing DH. Analytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus. PLoS One. 2015 Nov 12;10(11):e0142216. doi: 10.1371/journal.pone.0142216. eCollection 2015. Erratum In: PLoS One. 2015;10(12):e0145896.</citation>
    <PMID>26562786</PMID>
  </reference>
  <reference>
    <citation>Mahilum-Tapay L, Laitila V, Wawrzyniak JJ, Lee HH, Alexander S, Ison C, Swain A, Barber P, Ushiro-Lumb I, Goh BT. New point of care Chlamydia Rapid Test--bridging the gap between diagnosis and treatment: performance evaluation study. BMJ. 2007 Dec 8;335(7631):1190-4. doi: 10.1136/bmj.39402.463854.AE. Epub 2007 Nov 30.</citation>
    <PMID>18055487</PMID>
  </reference>
  <reference>
    <citation>Shin DJ, Trick AY, Hsieh YH, Thomas DL, Wang TH. Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation. Sci Rep. 2018 Jun 28;8(1):9793. doi: 10.1038/s41598-018-28124-3.</citation>
    <PMID>29955160</PMID>
  </reference>
  <reference>
    <citation>Bajis S, Maher L, Treloar C, Hajarizadeh B, Lamoury FMJ, Mowat Y, Schulz M, Marshall AD, Cunningham EB, Cock V, Ezard N, Gorton C, Hayllar J, Smith J, Whelan M, Martinello M, Applegate TL, Dore GJ, Grebely J; LiveRLife Study Group. Acceptability and preferences of point-of-care finger-stick whole-blood and venepuncture hepatitis C virus testing among people who inject drugs in Australia. Int J Drug Policy. 2018 Nov;61:23-30. doi: 10.1016/j.drugpo.2018.08.011. Epub 2018 Oct 25.</citation>
    <PMID>30388566</PMID>
  </reference>
  <reference>
    <citation>Fekete T. The Xpert HCV Viral Load Finger-Stick point-of-care test was accurate for detecting HCV RNA. Ann Intern Med. 2018 Sep 18;169(6):JC35. doi: 10.7326/ACPJC-2018-169-6-035. No abstract available.</citation>
    <PMID>30242408</PMID>
  </reference>
  <reference>
    <citation>Lamoury FMJ, Bajis S, Hajarizadeh B, Marshall AD, Martinello M, Ivanova E, Catlett B, Mowat Y, Marks P, Amin J, Smith J, Ezard N, Cock V, Hayllar J, Persing DH, Kleman M, Cunningham P, Dore GJ, Applegate TL, Grebely J; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay. J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114.</citation>
    <PMID>29534185</PMID>
  </reference>
  <reference>
    <citation>Grebely J, Lamoury FMJ, Hajarizadeh B, Mowat Y, Marshall AD, Bajis S, Marks P, Amin J, Smith J, Edwards M, Gorton C, Ezard N, Persing D, Kleman M, Cunningham P, Catlett B, Dore GJ, Applegate TL; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):514-520. doi: 10.1016/S2468-1253(17)30075-4. Epub 2017 Apr 22.</citation>
    <PMID>28442271</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>viral load testing</keyword>
  <keyword>point of care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767231
org study id: IRB00171078
nct id: NCT03767231
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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. The ED HCV Screening and Linkage to Care (LTC) Program will 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 a part of standard of care. The ED
           HCV Screening and LTC team will notify the research coordinator of all eligible
           patients.

        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. 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. 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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Acceptability of POC HCV viral load testing as assessed by a Likert scale
time frame: At the time of enrollment, up to 15 minutes
description: 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.
measure: Linkage to care rates between the HCV POC VL group and the control group
time frame: 12 months
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
arm group label: HCV POC VL Group
arm group type: Experimental
description: 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.
arm group label: Reference Group
arm group type: No Intervention
description: 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.
intervention type: Diagnostic Test
intervention name: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
description: 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. 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.
arm group label: HCV POC VL Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Yu-Hsiang Hsieh, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Deanna Myer
phone: 443-287-6985
email: dmyer1@jhmi.edu
last name: Tiana Jones
phone: 410-735-6422
email: tpurrin1@jhmi.edu
facility: 
contact: 
contact backup: 
country: United States
url: http://www.who.int/mediacentre/factsheets/fs164/en/
description: Hepatitis C - Fact Sheet. World Health Organization, 2017.
citation: Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, Jewett A, Baack B, Rein DB, Patel N, Alter M, Yartel A, Ward JW; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012 Aug 17;61(RR-4):1-32. Erratum In: MMWR Recomm Rep. 2012 Nov 2;61(43):886.
PMID: 22895429
citation: Grebely J, Applegate TL, Cunningham P, Feld JJ. Hepatitis C point-of-care diagnostics: in search of a single visit diagnosis. Expert Rev Mol Diagn. 2017 Dec;17(12):1109-1115. doi: 10.1080/14737159.2017.1400385. Epub 2017 Nov 8.
PMID: 29088981
citation: Rein DB, Wittenborn JS, Weinbaum CM, Sabin M, Smith BD, Lesesne SB. Forecasting the morbidity and mortality associated with prevalent cases of pre-cirrhotic chronic hepatitis C in the United States. Dig Liver Dis. 2011 Jan;43(1):66-72. doi: 10.1016/j.dld.2010.05.006. Epub 2010 Jun 17.
PMID: 20739252
citation: Brillman JC, Crandall CS, Florence CS, Jacobs JL. Prevalence and risk factors associated with hepatitis C in ED patients. Am J Emerg Med. 2002 Sep;20(5):476-80. doi: 10.1053/ajem.2002.32642.
PMID: 12216048
citation: Galbraith JW, Franco RA, Donnelly JP, Rodgers JB, Morgan JM, Viles AF, Overton ET, Saag MS, Wang HE. Unrecognized chronic hepatitis C virus infection among baby boomers in the emergency department. Hepatology. 2015 Mar;61(3):776-82. doi: 10.1002/hep.27410. Epub 2015 Jan 28.
PMID: 25179527
citation: Hsieh YH, Rothman RE, Laeyendecker OB, Kelen GD, Avornu A, Patel EU, Kim J, Irvin R, Thomas DL, Quinn TC. Evaluation of the Centers for Disease Control and Prevention Recommendations for Hepatitis C Virus Testing in an Urban Emergency Department. Clin Infect Dis. 2016 May 1;62(9):1059-65. doi: 10.1093/cid/ciw074. Epub 2016 Feb 21.
PMID: 26908800
citation: Kelen GD, Green GB, Purcell RH, Chan DW, Qaqish BF, Sivertson KT, Quinn TC. Hepatitis B and hepatitis C in emergency department patients. N Engl J Med. 1992 May 21;326(21):1399-404. doi: 10.1056/NEJM199205213262105.
PMID: 1373867
citation: Lyons MS, Kunnathur VA, Rouster SD, Hart KW, Sperling MI, Fichtenbaum CJ, Sherman KE. Prevalence of Diagnosed and Undiagnosed Hepatitis C in a Midwestern Urban Emergency Department. Clin Infect Dis. 2016 May 1;62(9):1066-71. doi: 10.1093/cid/ciw073. Epub 2016 Feb 21.
PMID: 26908799
citation: Anderson ES, Galbraith JW, Deering LJ, Pfeil SK, Todorovic T, Rodgers JB, Forsythe JM, Franco R, Wang H, Wang NE, White DAE. Continuum of Care for Hepatitis C Virus Among Patients Diagnosed in the Emergency Department Setting. Clin Infect Dis. 2017 Jun 1;64(11):1540-1546. doi: 10.1093/cid/cix163. Erratum In: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433.
PMID: 28207069
citation: McHugh MP, Wu AHB, Chevaliez S, Pawlotsky JM, Hallin M, Templeton KE. Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay. J Clin Microbiol. 2017 May;55(5):1550-1556. doi: 10.1128/JCM.02460-16. Epub 2017 Mar 8.
PMID: 28275079
citation: Pinsky BA, Sahoo MK, Sandlund J, Kleman M, Kulkarni M, Grufman P, Nygren M, Kwiatkowski R, Baron EJ, Tenover F, Denison B, Higuchi R, Van Atta R, Beer NR, Carrillo AC, Naraghi-Arani P, Mire CE, Ranadheera C, Grolla A, Lagerqvist N, Persing DH. Analytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus. PLoS One. 2015 Nov 12;10(11):e0142216. doi: 10.1371/journal.pone.0142216. eCollection 2015. Erratum In: PLoS One. 2015;10(12):e0145896.
PMID: 26562786
citation: Mahilum-Tapay L, Laitila V, Wawrzyniak JJ, Lee HH, Alexander S, Ison C, Swain A, Barber P, Ushiro-Lumb I, Goh BT. New point of care Chlamydia Rapid Test--bridging the gap between diagnosis and treatment: performance evaluation study. BMJ. 2007 Dec 8;335(7631):1190-4. doi: 10.1136/bmj.39402.463854.AE. Epub 2007 Nov 30.
PMID: 18055487
citation: Shin DJ, Trick AY, Hsieh YH, Thomas DL, Wang TH. Sample-to-Answer Droplet Magnetofluidic Platform for Point-of-Care Hepatitis C Viral Load Quantitation. Sci Rep. 2018 Jun 28;8(1):9793. doi: 10.1038/s41598-018-28124-3.
PMID: 29955160
citation: Bajis S, Maher L, Treloar C, Hajarizadeh B, Lamoury FMJ, Mowat Y, Schulz M, Marshall AD, Cunningham EB, Cock V, Ezard N, Gorton C, Hayllar J, Smith J, Whelan M, Martinello M, Applegate TL, Dore GJ, Grebely J; LiveRLife Study Group. Acceptability and preferences of point-of-care finger-stick whole-blood and venepuncture hepatitis C virus testing among people who inject drugs in Australia. Int J Drug Policy. 2018 Nov;61:23-30. doi: 10.1016/j.drugpo.2018.08.011. Epub 2018 Oct 25.
PMID: 30388566
citation: Fekete T. The Xpert HCV Viral Load Finger-Stick point-of-care test was accurate for detecting HCV RNA. Ann Intern Med. 2018 Sep 18;169(6):JC35. doi: 10.7326/ACPJC-2018-169-6-035. No abstract available.
PMID: 30242408
citation: Lamoury FMJ, Bajis S, Hajarizadeh B, Marshall AD, Martinello M, Ivanova E, Catlett B, Mowat Y, Marks P, Amin J, Smith J, Ezard N, Cock V, Hayllar J, Persing DH, Kleman M, Cunningham P, Dore GJ, Applegate TL, Grebely J; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay. J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114.
PMID: 29534185
citation: Grebely J, Lamoury FMJ, Hajarizadeh B, Mowat Y, Marshall AD, Bajis S, Marks P, Amin J, Smith J, Edwards M, Gorton C, Ezard N, Persing D, Kleman M, Cunningham P, Catlett B, Dore GJ, Applegate TL; LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):514-520. doi: 10.1016/S2468-1253(17)30075-4. Epub 2017 Apr 22.
PMID: 28442271
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis
sharing ipd: No