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Universal HIV Screening and Targeted HCV Screening in Emergency Department

Primary Purpose

Hepatitis C, Hiv

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HIV and HCV screening
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatitis C focused on measuring Screening, Linkage to care

Eligibility Criteria

18 Years - 73 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients consulting in the emergency room

Arm Description

Patients consulting in the emergency room.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence Among Baby-boomers
Determine the prevalence of new cases of HCV among "baby boomers" (1945 - 1975)
Opt-out
Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER
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
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)

Full Information

First Posted
July 5, 2018
Last Updated
February 7, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Ministere de la Sante et des Services Sociaux, Gilead Sciences, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03595527
Brief Title
Universal HIV Screening and Targeted HCV Screening in Emergency Department
Official Title
Universal HIV Screening and Targeted HCV Screening in Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Ministere de la Sante et des Services Sociaux, Gilead Sciences, Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hiv
Keywords
Screening, Linkage to care

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients consulting in the emergency room
Arm Type
Experimental
Arm Description
Patients consulting in the emergency room.
Intervention Type
Diagnostic Test
Intervention Name(s)
HIV and HCV screening
Intervention Description
HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott
Primary Outcome Measure Information:
Title
Prevalence
Description
Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Prevalence Among Baby-boomers
Description
Determine the prevalence of new cases of HCV among "baby boomers" (1945 - 1975)
Time Frame
10 months
Title
Opt-out
Description
Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER
Time Frame
10 months
Title
Initial Workup
Description
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
Time Frame
1 month
Title
Cascade of Care
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals attending the emergency room of the Centre hospitalier de l'Université de Montréal Exclusion Criteria: Individuals unable to opt-out due to their psychological or physical condition
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35042704
Citation
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.
Results Reference
derived

Learn more about this trial

Universal HIV Screening and Targeted HCV Screening in Emergency Department

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