Active or Ex-injection Drug Users Clinical Trial
| Verified date | January 2017 |
| Source | Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 67 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) | Fonds de la Recherche en Santé du Québec |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients for whom Oraquick HCV Antibody Test accurately diagnosed anti-HCV status | 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). |
Patients will be followed for an expected average of 6 weeks | |
| Secondary | Loss to follow up | Proportion of patients not completing the screening procedures | 3 months | |
| Secondary | Linkage to care | Proportion of infected patients initiating a follow up with an hepatitis C specialized provider | 6 months | |
| Secondary | Avoided costs | Costs that could have been avoided by the use of the rapid test. | 6 months | |
| Secondary | Satisfaction | Patients and provider satisfaction about the test | 15 minutes |