Universal HIV Screening and Targeted HCV Screening in Emergency Department

February 7, 2023 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients consulting in the emergency room
Patients consulting in the emergency room.
Diagnostic test: HIV and HCV screening
HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence
Time Frame: 10 months
Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence Among Baby-boomers
Time Frame: 10 months
Determine the prevalence of new cases of HCV among "baby boomers" (1945 - 1975)
10 months
Opt-out
Time Frame: 10 months
Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER
10 months
Initial Workup
Time Frame: 1 month
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
1 month
Cascade of Care
Time Frame: 3 months
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Merck Sharp & Dohme LLC
Gilead Sciences
Ministere de la Sante et des Services Sociaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2018

Primary Completion (ACTUAL)

October 10, 2019

Study Completion (ACTUAL)

October 10, 2020

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (ACTUAL)

July 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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