Universal HIV Screening and Targeted HCV Screening in Emergency Department

Hiv Clinical Trial

Official title:

Universal HIV Screening and Targeted HCV Screening in Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595527
• Other study ID #: 17.300
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: October 10, 2020

Study information

• Verified date: February 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6350
• Est. completion date: October 10, 2020
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hepatitis C
• Hiv

Intervention

Diagnostic Test:
• HIV and HCV screening
HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (4)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence	Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)	10 months
Secondary	Prevalence Among Baby-boomers	Determine the prevalence of new cases of HCV among "baby boomers" (1945 - 1975)	10 months
Secondary	Opt-out	Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER	10 months
Secondary	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	1 month
Secondary	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)	3 months