ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/13/2019 |
| Start Date: | June 2019 |
| End Date: | June 2021 |
| Contact: | Deanna Myer |
| Email: | dmyer1@jhmi.edu |
| Phone: | 443-287-6985 |
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 before randomization.
As part of the investigators' ED HCV Screening and Linkage to Care Program, all participants
will receive the standard-of-care clinical laboratory-based HCV RNA viral load testing via
whole blood (i.e. patient will receive blood drawn). This standard-of-care HCV viral load
testing result will be provided to participant when it is available (usually 1-2 days later).
Participants in the POC Testing Group will receive the novel POC HCV RNA viral load testing
and the result of the novel test will be disclosed to the patients approximately within 2
hours of the testing. A short survey will be conducted just for the POC Testing Group after
participants receive the test result of the novel assay. Linkage to care information after
the ED visit will be compared between two groups. Finally, accuracy of this POC HCV RNA viral
load testing in the acute care setting will be determined as compared to the standard-of-care
clinical laboratory-based HCV RNA viral load testing. The investigators will also ask all of
participants to grant permission to use the remnant blood specimens for an evaluation of an
in-house HCV RNA viral load assay developed by Dr. Tza-Huei Wang's group at Institute for
NanoBioTechnology, The Johns Hopkins University.
United States. Approximately 75% of individuals who have been infected with HCV are
chronically infected with the virus. Untreated chronic infection will lead to severe sequelae
such as cirrhosis and hepatocellular carcinoma. Even though the availability of rapid HCV
antibody (HCV Ab) screening assay and highly effective antiviral treatment, most people
infected with HCV are not aware of the infection status. This gap mainly comes from the
current gold standard confirmatory testing for chronic HCV infection, the Polymerase Chain
Reaction (PCR)-based HCV RNA viral load assay which requires an experienced trained
laboratory technician to perform relatively complicated PCR assay with a turn-around-time of
1 to 2 days (from provider's order to the test resulting). The investigators' rapid HCV
Screening and Linkage to Care program has demonstrated that many patients in the
investigators' emergency department (ED) are unaware of patient's chronic HCV infection
status due to the barriers to receive the gold standard viral load testing.
Recently, a novel Xpert HCV Viral Load (VL) Finger-stick (FS) [Xpert HCV VL FS] point-of-care
(POC) test (Cepheid) has been developed. In an observational cohort in Australia, HCV RNA was
detected in 40% of participants (85 of 210) enrolled at 3 drug treatment clinics and 1
homelessness service. Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in
samples collected by finger-stick was 100.0% (95% Confidence Interval (CI), 93.9%-100.0%) and
specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect
active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis.
In this protocol, the investigators seek to determine the needs and acceptability of a novel
POC HCV viral load testing assay among ED HCV Ab positive patients. For this project, the
investigators will identify and enroll ED patients with HCV Ab positive but without HCV viral
information. The investigators will conduct a randomized study to assign eligible and
consented patients to either to POC Testing Group or Standard of Care (SOC) Group. All
participants will take a short survey regarding HCV care and treatment before randomization.
As part of the investigators' ED HCV Screening and Linkage to Care Program, all participants
will receive the standard-of-care clinical laboratory-based HCV RNA viral load testing via
whole blood (i.e. patient will receive blood drawn). This standard-of-care HCV viral load
testing result will be provided to participant when it is available (usually 1-2 days later).
Participants in the POC Testing Group will receive the novel POC HCV RNA viral load testing
and the result of the novel test will be disclosed to the patients approximately within 2
hours of the testing. A short survey will be conducted just for the POC Testing Group after
participants receive the test result of the novel assay. Linkage to care information after
the ED visit will be compared between two groups. Finally, accuracy of this POC HCV RNA viral
load testing in the acute care setting will be determined as compared to the standard-of-care
clinical laboratory-based HCV RNA viral load testing. The investigators will also ask all of
participants to grant permission to use the remnant blood specimens for an evaluation of an
in-house HCV RNA viral load assay developed by Dr. Tza-Huei Wang's group at Institute for
NanoBioTechnology, The Johns Hopkins University.
Johns Hopkins Emergency Department-Based Rapid HCV Screening and Linkage to Care Program
Johns Hopkins Hospital Emergency Department (JHHED) has implemented an ED-based rapid HCV
Screening and Linkage to Care Program since late 2015, after adapting the 2012 Centers for
Disease Control and Prevention (CDC) revised HCV testing recommendations. The investigators'
program utilizes an integrated, triage nurse driven model to deliver opt-out HCV testing to
eligible ED patients. Eligibility was facilitated by electronic health record (EHR) prompts
to identify patients over the age of 17 years and no HCV testing history at the institution.
For patients who were medically/surgically stable and who did not have altered mental status,
an opt-out HCV Ab test offering was delivered by staff. JHHED utilizes the blood-based
anti-HCV assay (Abbott Architect) and fingerstick POC HCV assay (OraSure) for HCV Ab testing,
depending on the availability of patient's whole blood drawn for his/her ED care. HCV reflex
RNA testing is performed for HCV Ab reactive patients tested by blood-based HCV Ab assay.
Blood specimens for HCV RNA testing are collected during the ED visit (if possible) for HCV
Ab reactive patients tested by POC HCV Ab assay with confirmatory testing performed
asynchronous to the ED visit. JHHED utilized dedicated linkage to care program staff that
contacted ED patients with HCV Ab reactive results to deliver confirmatory results and
facilitate referral to HCV care. The investigators' program staff also identify HCV Ab
positive patients without HCV RNA viral load information by screening the ED tracking board
(EPIC) to inform ED providers of ordering HCV RNA viral load testing which might need to have
blood drawing if there is no blood work ordered in place.
Routine Care All JHHED patients are eligible for HCV screening or linkage to care service
under the investigators' ED-based rapid HCV Screening and Linkage to Care Program if
participants are 18 years and older, no history of HCV diagnosis or testing, and do not have
altered mental status. Please see the brief description of the investigators' program above.
Recruitment A. Steps for recruiting participants with known HCV antibody positive but no HCV
viral load data
1. Research coordinator will first screen the ED tracking board (EPIC) for patients who
potentially meet study enrollment criteria (i.e. not possessing any exclusion criteria),
which is done routinely as part of the ED HCV Screening and Linkage to Care Program.
2. Research coordinator will then approach the treating ED clinician for his/her patients
regarding the research opportunity in the investigators' study.
3. Providers may refer eligible patients to research coordinator after getting permission
from patients. Providers who are part of the investigators' study team will refer the
eligible patients to research coordinator after patients agree to be approached by the
investigators' research coordinator regarding the investigators' study.
For providers who are not in the investigators' study team, the recruitment procedure will be
that the patient's clinician will request permission from patients and document in the chart
regarding the patient's permission to be contacted by the research staff.
B. Steps for recruiting participants with newly diagnosed HCV antibody positive identified
from ED HCV Screening and Linkage to Care Program
1. Research coordinator will work closely with ED HCV Screening and Linkage to Care Program
staff to recruit this subgroup of ED patients. Screening Program staff will notify the
research coordinator via pager (or equivalent) when an ED patient is diagnosed with HCV
Ab reactive result via the Screening Program.
2. Research coordinator will then approach the treating ED clinician for his/her patients
regarding the research opportunity in the investigators' study.
3. Providers may refer eligible patients to research coordinator after getting permission
from patients. Providers who are part of the investigators' study team will refer the
eligible patients to research coordinator after patients agree to be approached by the
investigators' research coordinator regarding the study.
For providers who are not in the investigators' study team, the recruitment procedure will be
that the patient's clinician will request permission from patients and document in the chart
regarding the patient's permission to be contacted by the research staff.
Enrollment The research coordinator will obtain oral, informed consent. The process will
involve a description of the study as provided in the verbal consent form with a chance to
provide answers to any questions about the study. Justification for verbal consent is
provided in the electronic Institutional Review Board (e-IRB) application. Specifically, this
study poses minimal risk to patients. The consent process will take between approximately
15-20 minutes, based on the requirements of the individual patient.
Consented subjects will be given a copy of the oral consent document for participant's
information and records. In this consent, the patient will be asked for permission to review
patient's medical charts at Johns Hopkins Hospital for the clinical information of the ED
visit and subsequent HCV-related visits. In addition, the patient will be asked for
permission to allow the investigators to use the remnant blood specimen of this study in the
future for an evaluation of an in-house HCV RNA viral load assay developed by Dr. Tza-Huei
Wang's group at Institute for NanoBioTechnology, The Johns Hopkins University. Consented
patients will be randomized to one of two groups, HCV POC Testing Group or Standard of Care
(SOC) Group. The testing group will receive the POC HCV viral load testing via fingerstick
using a novel Xpert HCV Viral Load Finger-stick (Xpert HCV VL FS) point-of-care (POC) test
and the reference group will not receive this POC VL testing. Both groups will receive stand
of care conventional laboratory-based whole blood HCV VL testing. Before the randomization,
consented patients in both groups will fill out a short survey regarding participant's
socio-demographic information as well as participant's experience, attitudes, and perceptions
regarding HCV testing and care. HCV POC Testing Group will fill out another short survey
after POC viral load testing regarding participant's experience, attitudes, and perceptions
regarding HCV POC viral load testing
Johns Hopkins Hospital Emergency Department (JHHED) has implemented an ED-based rapid HCV
Screening and Linkage to Care Program since late 2015, after adapting the 2012 Centers for
Disease Control and Prevention (CDC) revised HCV testing recommendations. The investigators'
program utilizes an integrated, triage nurse driven model to deliver opt-out HCV testing to
eligible ED patients. Eligibility was facilitated by electronic health record (EHR) prompts
to identify patients over the age of 17 years and no HCV testing history at the institution.
For patients who were medically/surgically stable and who did not have altered mental status,
an opt-out HCV Ab test offering was delivered by staff. JHHED utilizes the blood-based
anti-HCV assay (Abbott Architect) and fingerstick POC HCV assay (OraSure) for HCV Ab testing,
depending on the availability of patient's whole blood drawn for his/her ED care. HCV reflex
RNA testing is performed for HCV Ab reactive patients tested by blood-based HCV Ab assay.
Blood specimens for HCV RNA testing are collected during the ED visit (if possible) for HCV
Ab reactive patients tested by POC HCV Ab assay with confirmatory testing performed
asynchronous to the ED visit. JHHED utilized dedicated linkage to care program staff that
contacted ED patients with HCV Ab reactive results to deliver confirmatory results and
facilitate referral to HCV care. The investigators' program staff also identify HCV Ab
positive patients without HCV RNA viral load information by screening the ED tracking board
(EPIC) to inform ED providers of ordering HCV RNA viral load testing which might need to have
blood drawing if there is no blood work ordered in place.
Routine Care All JHHED patients are eligible for HCV screening or linkage to care service
under the investigators' ED-based rapid HCV Screening and Linkage to Care Program if
participants are 18 years and older, no history of HCV diagnosis or testing, and do not have
altered mental status. Please see the brief description of the investigators' program above.
Recruitment A. Steps for recruiting participants with known HCV antibody positive but no HCV
viral load data
1. Research coordinator will first screen the ED tracking board (EPIC) for patients who
potentially meet study enrollment criteria (i.e. not possessing any exclusion criteria),
which is done routinely as part of the ED HCV Screening and Linkage to Care Program.
2. Research coordinator will then approach the treating ED clinician for his/her patients
regarding the research opportunity in the investigators' study.
3. Providers may refer eligible patients to research coordinator after getting permission
from patients. Providers who are part of the investigators' study team will refer the
eligible patients to research coordinator after patients agree to be approached by the
investigators' research coordinator regarding the investigators' study.
For providers who are not in the investigators' study team, the recruitment procedure will be
that the patient's clinician will request permission from patients and document in the chart
regarding the patient's permission to be contacted by the research staff.
B. Steps for recruiting participants with newly diagnosed HCV antibody positive identified
from ED HCV Screening and Linkage to Care Program
1. Research coordinator will work closely with ED HCV Screening and Linkage to Care Program
staff to recruit this subgroup of ED patients. Screening Program staff will notify the
research coordinator via pager (or equivalent) when an ED patient is diagnosed with HCV
Ab reactive result via the Screening Program.
2. Research coordinator will then approach the treating ED clinician for his/her patients
regarding the research opportunity in the investigators' study.
3. Providers may refer eligible patients to research coordinator after getting permission
from patients. Providers who are part of the investigators' study team will refer the
eligible patients to research coordinator after patients agree to be approached by the
investigators' research coordinator regarding the study.
For providers who are not in the investigators' study team, the recruitment procedure will be
that the patient's clinician will request permission from patients and document in the chart
regarding the patient's permission to be contacted by the research staff.
Enrollment The research coordinator will obtain oral, informed consent. The process will
involve a description of the study as provided in the verbal consent form with a chance to
provide answers to any questions about the study. Justification for verbal consent is
provided in the electronic Institutional Review Board (e-IRB) application. Specifically, this
study poses minimal risk to patients. The consent process will take between approximately
15-20 minutes, based on the requirements of the individual patient.
Consented subjects will be given a copy of the oral consent document for participant's
information and records. In this consent, the patient will be asked for permission to review
patient's medical charts at Johns Hopkins Hospital for the clinical information of the ED
visit and subsequent HCV-related visits. In addition, the patient will be asked for
permission to allow the investigators to use the remnant blood specimen of this study in the
future for an evaluation of an in-house HCV RNA viral load assay developed by Dr. Tza-Huei
Wang's group at Institute for NanoBioTechnology, The Johns Hopkins University. Consented
patients will be randomized to one of two groups, HCV POC Testing Group or Standard of Care
(SOC) Group. The testing group will receive the POC HCV viral load testing via fingerstick
using a novel Xpert HCV Viral Load Finger-stick (Xpert HCV VL FS) point-of-care (POC) test
and the reference group will not receive this POC VL testing. Both groups will receive stand
of care conventional laboratory-based whole blood HCV VL testing. Before the randomization,
consented patients in both groups will fill out a short survey regarding participant's
socio-demographic information as well as participant's experience, attitudes, and perceptions
regarding HCV testing and care. HCV POC Testing Group will fill out another short survey
after POC viral load testing regarding participant's experience, attitudes, and perceptions
regarding HCV POC viral load testing
Inclusion Criteria:
- Any Johns Hopkins Emergency Department patient who has HCV antibody positive result
but no HCV RNA test result in the chart
- Able to provide informed consent
- 18-100 years
Exclusion Criteria:
- Patient who has a diagnosis of chronic HCV infection
- Patient with a non-reactive test result of an HCV Ab screening test
- Patient with a chief complaint of sexual assault
- Patients who are otherwise ineligible to consent due to medical condition (e.g.,
severe illness, altered mental status)
- Any person who has previously enrolled in this study
- Any person less than 18 years of age
- Any person who is incarcerated
- Any woman who is pregnant
- Any person who is transgender
- Any person who is sex worker
- Any person who is refugee
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 443-287-6985
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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