Universal HIV Screening and Targeted HCV Screening in Emergency Department

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Completed
CT.gov ID
NCT03595527
Collaborator
Ministere de la Sante et des Services Sociaux (Other), Gilead Sciences (Industry), Merck Sharp & Dohme LLC (Industry)
4,163
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HIV and HCV screening
N/A

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

Study Type:
Interventional
Actual Enrollment :
4163 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Universal HIV Screening and Targeted HCV Screening in Emergency Department
Actual Study Start Date :
Jul 10, 2018
Actual Primary Completion Date :
Oct 10, 2019
Actual Study Completion Date :
Oct 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence [4 months]

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

Secondary Outcome Measures

  1. Prevalence among baby-boomers [4 months]

    Determine the prevalence of new and pre-existing cases of HCV among "baby boomers" (1945 - 1975 years)

  2. Opt-out [4 months]

    Determine the proportion of patients that opted-out of the routine screening for HIV and HCV at the ER

  3. Initial workup [1 year]

    Among patients with a newly positive HIV or HCV test in the ER, determine the proportion of those who attended a first workup appointment at 1 month

  4. Cascade of care [1 year]

    Determine the proportion that completed certain steps of the HIV and HCV care cascades at 1 or 3 months, ie confirmation of diagnosis (HIV and HCV: 1 month), liver fibrosis assessment (HCV: 3 months), and treatment initiation (HIV: 1 month and HCV: 3 months)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 73 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de l'Université de Montréal Montréal Quebec Canada H2X 3E4

Sponsors and Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)
  • Ministere de la Sante et des Services Sociaux
  • Gilead Sciences
  • Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT03595527
Other Study ID Numbers:
  • 17.300
First Posted:
Jul 23, 2018
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2021