Back to resultsComparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care
Primary Purpose
Active or Ex-injection Drug Users, Indication of Hepatitis C Screening
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oraquick HCV Rapid Antibody Test
Standard algorithm
Sponsored by
About this trial
This is an interventional diagnostic trial for Active or Ex-injection Drug Users
Eligibility Criteria
Inclusion Criteria:
- Indication of hepatitis C screening
- Active or ex-injection drug user
Exclusion Criteria:
- Known hepatitis C infection
- Unknown HIV status and patient refusing to HIV testing
Sites / Locations
- Centre Hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test
Patients will be tested only with the standard algorithm
Outcomes
Primary Outcome Measures
Proportion of patients for whom Oraquick HCV Antibody Test accurately diagnosed anti-HCV status
Oraquick HCV Antibody test will be compared to a composite goldstandard:
If both the Oraquick test and the standard test are negative, the results will be considered as a true negative.
If both the Oraquick test and the standard test are positive, the results will be considered as a true positive.
If the tests are discordant, HCV RNA testing will be performed. If HCV RNA is positive, the result of the test who predicted the positive result will be a true positive and the result of the other test will be a false negative. If the HCV RNA is negative, the result of the standard test will be considered as the true value (either positive or negative).
Secondary Outcome Measures
Loss to follow up
Proportion of patients not completing the screening procedures
Linkage to care
Proportion of infected patients initiating a follow up with an hepatitis C specialized provider
Avoided costs
Costs that could have been avoided by the use of the rapid test.
Satisfaction
Patients and provider satisfaction about the test
Full Information
NCT ID
NCT02084719
First Posted
March 7, 2014
Last Updated
January 19, 2017
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Fonds de la Recherche en Santé du Québec
1. Study Identification
Unique Protocol Identification Number
NCT02084719
Brief Title
Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitement
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Fonds de la Recherche en Santé du Québec
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rapid tests are increasingly used in medical practice, notably to screen for HIV. Their use has been associated with a faster linkage to care and lower rates of loss to follow up. Rapid tests are also well accepted by patients and clinicians.
No rapid test is currently approved in Canada for screening of hepatitis C. Hepatitis C diagnosis is done through based on blood testing and the screening algorithm may require up to 3 visits to clarify the hepatitis C status.
The Oraquick HCV test is a rapid test done on blood or saliva that can replace the first step of the regular screening algorithm. With this test the initial screening and the confirmation test can be done in one visit.
The primary endpoint of this pilot-project is to evaluate clinical characteristics of Oracquick HCV (sensitivity, specificity, positive and negative predictive values) and to compare them to those of the standard screening algorithm in a population of active or ex-users of injected drugs. The project also intend to evaluate if the rapid test can reduce the rates of loss to follow up and increase the linkage to hepatitis C specialized care. This last endpoint will be evaluated through phone call follow up 6 months after the screening.
One hundred and fifty patients will be included. Half will be tested with the standard algorithm and the Oraquick HCV test (group A) and half will be tested only with the standard algorithm.
Results of group A will be used to determine the clinical characteristics of Oraquick HCV. Results of groups A and B will be used to evaluate rates of loss to follow up, costs avoided by the use of the rapid test and linkage to care of infected patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active or Ex-injection Drug Users, Indication of Hepatitis C Screening
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients will be tested only with the standard algorithm
Intervention Type
Device
Intervention Name(s)
Oraquick HCV Rapid Antibody Test
Intervention Type
Device
Intervention Name(s)
Standard algorithm
Primary Outcome Measure Information:
Title
Proportion of patients for whom Oraquick HCV Antibody Test accurately diagnosed anti-HCV status
Description
Oraquick HCV Antibody test will be compared to a composite goldstandard:
If both the Oraquick test and the standard test are negative, the results will be considered as a true negative.
If both the Oraquick test and the standard test are positive, the results will be considered as a true positive.
If the tests are discordant, HCV RNA testing will be performed. If HCV RNA is positive, the result of the test who predicted the positive result will be a true positive and the result of the other test will be a false negative. If the HCV RNA is negative, the result of the standard test will be considered as the true value (either positive or negative).
Time Frame
Patients will be followed for an expected average of 6 weeks
Secondary Outcome Measure Information:
Title
Loss to follow up
Description
Proportion of patients not completing the screening procedures
Time Frame
3 months
Title
Linkage to care
Description
Proportion of infected patients initiating a follow up with an hepatitis C specialized provider
Time Frame
6 months
Title
Avoided costs
Description
Costs that could have been avoided by the use of the rapid test.
Time Frame
6 months
Title
Satisfaction
Description
Patients and provider satisfaction about the test
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Indication of hepatitis C screening
Active or ex-injection drug user
Exclusion Criteria:
Known hepatitis C infection
Unknown HIV status and patient refusing to HIV testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Martel-Laferrière, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 2W5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care
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