Active or Ex-injection Drug UsersNCT02084719
Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care
A study testing Oraquick HCV Rapid Antibody Test and Standard algorithm in people with Active or Ex-injection Drug Users and Indication of Hepatitis C Screening, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Active or Ex-injection Drug Users, Indication of Hepatitis C Screening
- What is being tested?
- Oraquick HCV Rapid Antibody Test and Standard algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication of hepatitis C screening
- Active or ex-injection drug user
Who cannot join
- Known hepatitis C infection
- Unknown HIV status and patient refusing to HIV testing
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 2W5
About this study
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.
Read more
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.
- Being tested
- Oraquick HCV Rapid Antibody Test, Standard algorithm
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oraquick HCV Rapid Antibody TestDevice
Standard algorithmDevice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test Receives: Device: Oraquick HCV Rapid Antibody Test; Device: Standard algorithm |
| Group B | Active comparator | Patients will be tested only with the standard algorithm Receives: Device: Standard algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Patients will be followed for an expected average of 6 weeks
Secondary outcomes (4)
Loss to follow up
Proportion of patients not completing the screening procedures
Measured: 3 months
Linkage to care
Proportion of infected patients initiating a follow up with an hepatitis C specialized provider
Measured: 6 months
Avoided costs
Costs that could have been avoided by the use of the rapid test.
Measured: 6 months
Satisfaction
Patients and provider satisfaction about the test
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Slow recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active or Ex-injection Drug UsersStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Valérie Martel-Laferrière, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Valérie Martel-Laferrière, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084719
- Sponsor's protocol ID
- 01
- Status last verified
- Jan 2017
- First submitted
- 7 Mar 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care
- ClinicalTrials.gov ID
- NCT02084719
- Acronym / sponsor ID
- 01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitement
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Oraquick HCV Rapid Antibody Test, Device: Standard algorithmPatients will be tests with both the standard algorithm and the Oraquick HCV Rapid Antibody Test |
| Group B | Active comparator | Device: Standard algorithmPatients will be tested only with the standard algorithm |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication of hepatitis C screening
- Active or ex-injection drug user
Key exclusion criteria (2 listed)
- Known hepatitis C infection
- Unknown HIV status and patient refusing to HIV testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oraquick HCV Rapid Antibody Test | Device | Group A |
| Standard algorithm | Device | Group A, Group B |
Primary outcome
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
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).
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Slow recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Martel-Laferrière, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oraquick HCV Rapid Antibody Test and Standard algorithm in people with Active or Ex-injection Drug Users and Indication of Hepatitis C Screening, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.