Clinical trial NCT02084719: Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Active or Ex-injection Drug Users
Indication of Hepatitis C Screening
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2014-03-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Proportion of patients for whom Oraquick HCV Antibody Test accurately diagnosed anti-HCV status
timeFrame: Patients will be followed for an expected average of 6 weeks
Secondary outcomes:
measure: Loss to follow up
timeFrame: 3 months
measure: Linkage to care
timeFrame: 6 months
measure: Avoided costs
timeFrame: 6 months
measure: Satisfaction
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Valérie Martel-Laferrière, MD
role: PRINCIPAL_INVESTIGATOR
References: