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

Not Applicable

Terminated

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

• Registration Number: NCT02084719
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Oraquick HCV Rapid Antibody Test	Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test
Group A	Standard algorithm	Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test
Group B	Standard algorithm	Patients will be tested only with the standard algorithm

Primary Outcome Measures

Name	Time	Method
Proportion of patients for whom Oraquick HCV Antibody Test accurately diagnosed anti-HCV status	Patients will be followed for an expected average of 6 weeks	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

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

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada