NCT03595527

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 10, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

July 5, 2018

Results QC Date

February 21, 2022

Last Update Submit

February 7, 2023

Conditions

Hepatitis CHiv

Keywords

ScreeningLinkage to care

Outcome Measures

Primary Outcomes (1)

  • Prevalence

    Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)

    10 months

Secondary Outcomes (4)

  • Prevalence Among Baby-boomers

    10 months

  • Opt-out

    10 months

  • Initial Workup

    1 month

  • Cascade of Care

    3 months

Study Arms (1)

Patients consulting in the emergency room

EXPERIMENTAL

Patients consulting in the emergency room.

Diagnostic Test: HIV and HCV screening

Interventions

HIV and HCV screeningDIAGNOSTIC_TEST

HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott

Patients consulting in the emergency room

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals attending the emergency room of the Centre hospitalier de l'Université de Montréal

You may not qualify if:

  • Individuals unable to opt-out due to their psychological or physical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35042704DERIVED

MeSH Terms

Conditions

Hepatitis CAcquired Immunodeficiency Syndrome

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Results Point of Contact

Title
Valréie Martel-Laferrière, MD
Organization
Centre hospitalier de l'Université de Montréal
valerie.martel-laferriere.med@ssss.gouv.qc.ca
5148908000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 23, 2018

Study Start

July 10, 2018

Primary Completion

October 10, 2019

Study Completion

October 10, 2020

Last Updated

February 10, 2023

Results First Posted

February 10, 2023

Record last verified: 2023-02

Locations

CA(1)