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

NCT ID: NCT02084719

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Oraquick HCV Rapid Antibody Test

Intervention Type: DEVICE

Standard algorithm

Intervention Type: DEVICE

Group B

Patients will be tested only with the standard algorithm

Group Type: ACTIVE_COMPARATOR

Standard algorithm

Intervention Type: DEVICE

Interventions

Oraquick HCV Rapid Antibody Test

Intervention Type: DEVICE

Standard algorithm

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Valérie Martel-Laferrière

MD, MS, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valérie Martel-Laferrière, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id