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

NCT03767231 | Not Yet Recruiting

• 1 other identifier: IRB00171078
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Hepatitis C

Keywords

viral load testing; point of care

Outcome Measures

Primary Outcomes (2)

• Acceptability of POC HCV viral load testing as assessed by a Likert scale

  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.

  At the time of enrollment, up to 15 minutes

• Linkage to care rates between the HCV POC VL group and the control group

  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.

  12 months

Secondary Outcomes (2)

• Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by sensitivity of the assay

  12 months

• Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by specificity of the assay

  12 months

Study Arms (2)

HCV POC VL Group

EXPERIMENTAL

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.

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

Reference Group

NO INTERVENTION

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.

Interventions

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

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.

HCV POC VL Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Cepheid: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (17)

• 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.

  PMID: 22895429 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28207069 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 26562786 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Hepatitis C - Fact Sheet. World Health Organization, 2017.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Yu-Hsiang Hsieh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaby Dashler

CONTACT

410-735-7077; ggladfe1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)