Hepatitis CNCT03767231
ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing
A study testing Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in people with Hepatitis C, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins University
Baltimore, Maryland, 21287
Gaby Dashler, 443-287-6985, ggladfe1@jhmi.edu
About this study
Official title: Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing
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.
Read the 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
- 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.
- Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study.
- 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.
- Steps for recruiting participants with newly diagnosed HCV antibody positive identified from ED HCV Screening and Linkage to Care Program
- 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.
- Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study.
- 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
- Conditions
- Hepatitis C
- Being tested
- Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
- Keywords
- viral load testing, point of care
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid
- Responsible party
- Sponsor
- Investigators
- Yu-Hsiang Hsieh, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767231
- Sponsor's protocol ID
- IRB00171078
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2018
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22895429Grebely 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.
PubMed 29088981Rein 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.
PubMed 20739252Brillman 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.
PubMed 12216048Galbraith 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.
PubMed 25179527Hsieh 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.
PubMed 26908800Kelen 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.
PubMed 1373867Lyons 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.
PubMed 26908799Anderson 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.
PubMed 28207069McHugh 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.
PubMed 28275079Pinsky 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.
PubMed 26562786Mahilum-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.
PubMed 18055487Shin 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.
PubMed 29955160Bajis 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.
PubMed 30388566Fekete 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.
PubMed 30242408
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing
- ClinicalTrials.gov ID
- NCT03767231
- Acronym / sponsor ID
- IRB00171078
- Conditions
- Hepatitis C
- Keywords
- viral load testing, point of care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Cepheid
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study.
- 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.
- Steps for recruiting participants with newly diagnosed HCV antibody positive identified from ED HCV Screening and Linkage to Care Program
- 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.
- Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study.
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV POC VL Group | Experimental | Diagnostic Test: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. 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. | Diagnostic test | HCV POC VL Group |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Background: PubMed 22895429Smith 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.
- Background: PubMed 29088981Grebely 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.
- Background: PubMed 20739252Rein 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.
- Background: PubMed 12216048Brillman 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.
- Background: PubMed 25179527Galbraith 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.
- Background: PubMed 26908800Hsieh 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.
- Background: PubMed 1373867Kelen 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.
- Background: PubMed 26908799Lyons 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.
- Background: PubMed 28207069Anderson 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.
- Background: PubMed 28275079McHugh 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.
- Background: PubMed 26562786Pinsky 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.
- Background: PubMed 18055487Mahilum-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.
- Hepatitis C - Fact Sheet. World Health Organization, 2017.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu-Hsiang Hsieh, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in people with Hepatitis C, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaby Dashler (410-735-7077, ggladfe1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767231, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.