Hepatitis CNCT03595527
Universal HIV Screening and Targeted HCV Screening in Emergency Department
A study testing HIV and HCV screening in people with Hepatitis C and Hiv, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Cross-sectional study of patients consulting in the emergency room of the Centre hospitalier de l'Université de Montréal (CHUM), to assess the implementation of an "opt-out" screening program for HIV and HCV and prospective follow-up for 3 months of positive cases. Read more about this study
- Who is it for?
- Ages 18 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hiv
- What is being tested?
- HIV and HCV screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,350 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2018to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals attending the emergency room of the Centre hospitalier de l'Université de Montréal
Who cannot join
- Individuals unable to opt-out due to their psychological or physical condition
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
Cross-sectional study of patients consulting in the emergency room of the Centre hospitalier de l'Université de Montréal (CHUM), to assess the implementation of an "opt-out" screening program for HIV and HCV and prospective follow-up for 3 months of positive cases.
Read the detailed description
The purpose of this study is to evaluate the feasibility of routine HIV and HCV screening using an "opt-out" approach at the emergency room of the CHUM and to determine the rate of new positive HIV and HCV cases. A sub-analysis will focus more specifically on HCV in the Quebec equivalent of "baby boomers" (1945-1975) since this is the group that was targeted in the United States. The second phase of this study will evaluate the effectiveness of the linkage to the healthcare system for people diagnosed with HIV or HCV and how fast these people are taken care of and put on treatment.
- Conditions
- Hepatitis C, Hiv
- Being tested
- HIV and HCV screening
- Keywords
- Screening, Linkage to care
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV and HCV screeningDiagnostic test
HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott
| Study group | Role | What they receive |
|---|---|---|
| Patients consulting in the emergency room | Experimental | Patients consulting in the emergency room. Receives: Diagnostic Test: HIV and HCV screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)
Measured: 10 months
Secondary outcomes (4)
Prevalence Among Baby-boomers
Determine the prevalence of new cases of HCV among "baby boomers" (1945 - 1975)
Measured: 10 months
Opt-out
Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER
Measured: 10 months
Initial Workup
Among patients with a newly positive HIV or HCV test in the ER, determine the percentage of those who attended a first workup appointment at 1 month
Measured: 1 month
Cascade of Care
Determine the percentage that completed certain steps of the HIV and HCV care cascades at 3 months, ie confirmation of diagnosis, liver fibrosis assessment (HCV), and treatment initiation (HIV) or prescription (HCV)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start10 Jul 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,350 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux, Gilead Sciences, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595527
- Sponsor's protocol ID
- 17.300
- Status last verified
- Feb 2023
- First submitted
- 5 Jul 2018
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martel-Laferriere V, Baril JG, Alarie I, Leblanc J, Cote J, Jourdenais E, Horth D, Lambert G, Tremblay C. Opt-out universal HCV and HIV screening in a Canadian emergency room: a cross-sectional study. BMJ Open. 2022 Jan 18;12(1):e048748. doi: 10.1136/bmjopen-2021-048748.
PubMed 35042704
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal HIV Screening and Targeted HCV Screening in Emergency Department
- ClinicalTrials.gov ID
- NCT03595527
- Acronym / sponsor ID
- 17.300
- Conditions
- Hepatitis C, Hiv
- Keywords
- Screening, Linkage to care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,350 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux, Gilead Sciences, Merck Sharp & Dohme LLC
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cross-sectional study of patients consulting in the emergency room of the Centre hospitalier de l'Université de Montréal (CHUM), to assess the implementation of an "opt-out" screening program for HIV and HCV and prospective follow-up for 3 months of positive cases.
Detailed description
The purpose of this study is to evaluate the feasibility of routine HIV and HCV screening using an "opt-out" approach at the emergency room of the CHUM and to determine the rate of new positive HIV and HCV cases. A sub-analysis will focus more specifically on HCV in the Quebec equivalent of "baby boomers" (1945-1975) since this is the group that was targeted in the United States. The second phase of this study will evaluate the effectiveness of the linkage to the healthcare system for people diagnosed with HIV or HCV and how fast these people are taken care of and put on treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients consulting in the emergency room | Experimental | Diagnostic Test: HIV and HCV screeningPatients consulting in the emergency room. |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals attending the emergency room of the Centre hospitalier de l'Université de Montréal
Key exclusion criteria (1 listed)
- Individuals unable to opt-out due to their psychological or physical condition
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 |
|---|---|---|
| HIV and HCV screeningHIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott | Diagnostic test | Patients consulting in the emergency room |
Primary outcome
Prevalence
Time frame: 10 months
Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)
4 secondary outcomes
Prevalence Among Baby-boomers
Time frame: 10 months
Opt-out
Time frame: 10 months
Initial Workup
Time frame: 1 month
Cascade of Care
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35042704Martel-Laferriere V, Baril JG, Alarie I, Leblanc J, Cote J, Jourdenais E, Horth D, Lambert G, Tremblay C. Opt-out universal HCV and HIV screening in a Canadian emergency room: a cross-sectional study. BMJ Open. 2022 Jan 18;12(1):e048748. doi: 10.1136/bmjopen-2021-048748.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV and HCV screening in people with Hepatitis C and Hiv, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595527, which also lists 1 linked publication.
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 10 Feb 2023.