Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care

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.

Study Overview

• Status: Terminated
• Conditions: Active or Ex-injection Drug Users; Indication of Hepatitis C Screening
• Intervention / Treatment: Device: Oraquick HCV Rapid Antibody Test; Device: Standard algorithm

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2L 2W5
      • Centre hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test	Device: Oraquick HCV Rapid Antibody Test; Device: Standard algorithm
Active Comparator: Group B; Patients will be tested only with the standard algorithm	Device: Standard algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Patients will be followed for an expected average of 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss to follow up	Proportion of patients not completing the screening procedures	3 months
Linkage to care	Proportion of infected patients initiating a follow up with an hepatitis C specialized provider	6 months
Avoided costs	Costs that could have been avoided by the use of the rapid test.	6 months
Satisfaction	Patients and provider satisfaction about the test	15 minutes

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Valérie Martel-Laferrière, MD, Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 7, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 01 (Miami VAHS)