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Rapid HCV Test for Hepatitis C
N/A
Waitlist Available
Led By Yu-Hsiang Hsieh, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will test a new, rapid HCV viral load test to see if it is accurate and acceptable to patients in the emergency department.
Who is the study for?
This trial is for adult patients (18-100 years old) at Johns Hopkins Emergency Department who have tested positive for HCV antibodies but don't yet have an HCV RNA test result. It's not open to those with severe illness, altered mental status, refugees, minors, chronic HCV diagnosis, non-reactive HCV Ab test results, sexual assault victims, incarcerated individuals, sex workers, previous enrollees in this study, pregnant women or transgender persons.Check my eligibility
What is being tested?
The trial is testing the acceptability of a new point-of-care Hepatitis C viral load test that gives results within an hour from a finger-stick sample. Participants will be randomly assigned to either receive this new rapid test or the standard lab-based viral load testing which takes 1-2 days for results.See study design
What are the potential side effects?
Since the intervention involves only diagnostic testing and not treatment medication there are no direct side effects related to drugs; however minor risks may include discomfort or bruising from the finger-stick blood collection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of POC HCV viral load testing as assessed by a Likert scale
Linkage to care rates between the HCV POC VL group and the control group
Secondary outcome measures
Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by sensitivity of the assay
Accuracy of an in-house POC HCV viral load assay (developed by Dr. Tza-Huei Wang) as assessed by specificity of the assay
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HCV POC VL GroupExperimental Treatment1 Intervention
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.
Group II: Reference GroupActive Control1 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.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,580 Total Patients Enrolled
18 Trials studying Hepatitis C
154,657 Patients Enrolled for Hepatitis C
Yu-Hsiang Hsieh, PhDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
508 Total Patients Enrolled
1 Trials studying Hepatitis C
308 Patients Enrolled for Hepatitis C
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.I have been diagnosed with chronic hepatitis C.I am seeking help following a sexual assault.Refugees are not eligible to participate.I am between 18 and 100 years old.I identify as transgender.People who work in the sex industry.I am under 18 years old.You have already been part of this study before.
Research Study Groups:
This trial has the following groups:- Group 1: HCV POC VL Group
- Group 2: Reference Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are newly recruited participants being accepted into this trial currently?
"According to clinicaltrials.gov, this medical research has suspended its patient recruitment efforts; the trial was initially published on October 1st 2023 and edited lastly on October 13th 2022. Nevertheless, 281 other trials are still welcoming participants."
Answered by AI
Is it possible to enlist in this clinical endeavor?
"This medical trial calls for 200 participants that have been diagnosed with hepatitis c and are between the ages of 18 to 100. To meet eligibility requirements, potential participants must be within this age bracket."
Answered by AI
Is senior participation encouraged in this research?
"This research program has a limited age range of 18 to 100, but there are additional trials for younger and older participants as well. Specifically, 27 studies cater towards those below the legal age limit while 237 cover individuals over 65 years old."
Answered by AI
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