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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Terminated

Conditions: Active or Ex-injection Drug Users; Indication of Hepatitis C Screening

Treatments: Device: Standard algorithm; Device: Oraquick HCV Rapid Antibody Test

Study type: Interventional

Funder types: Other

Identifiers

NCT02084719

01

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Group A

Experimental group

Description:

Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test

Treatment:

Device: Standard algorithm

Device: Oraquick HCV Rapid Antibody Test

Group B

Active Comparator group

Description:

Patients will be tested only with the standard algorithm

Treatment:

Device: Standard algorithm