Overview

This trial is active, not recruiting.

Conditions active or ex-injection drug users, indication of hepatitis c screening
Treatments oraquick hcv rapid antibody test, standard algorithm
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator Fonds de la Recherche en Santé du Québec
Start date March 2014
End date September 2016
Trial size 67 participants
Trial identifier NCT02084719, 01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test
oraquick hcv rapid antibody test
standard algorithm
(Active Comparator)
Patients will be tested only with the standard algorithm
standard algorithm

Primary Outcomes

Measure
Proportion of patients for whom Oraquick HCV Antibody Test accurately diagnosed anti-HCV status
time frame: Patients will be followed for an expected average of 6 weeks

Secondary Outcomes

Measure
Loss to follow up
time frame: 3 months
Linkage to care
time frame: 6 months
Avoided costs
time frame: 6 months
Satisfaction
time frame: 15 minutes

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

Principal investigator Valérie Martel-Laferrière, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM).