Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Universal HIV Screening and Targeted HCV Screening in Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595527
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
Ministere de la Sante et des Services Sociaux
Gilead Sciences
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Hepatitis C Hiv Diagnostic Test: HIV and HCV screening Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : July 10, 2018
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevalence [ Time Frame: 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 [ Time Frame: 4 months ]
    Determine the prevalence of new and pre-existing cases of HCV among "baby boomers" (1945 - 1975 years)

  2. Opt-out [ Time Frame: 4 months ]
    Determine the proportion of patients that opted-out of the routine screening for HIV and HCV at the ER

  3. Initial workup [ Time Frame: 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 [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595527


Locations
Layout table for location information
Canada, Quebec
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 Corp.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03595527    
Other Study ID Numbers: 17.300
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2020

Layout table for additional information
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):
Screening
Linkage to care
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Emergencies
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
 Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Disease Attributes
Pathologic Processes