Universal HIV Screening and Targeted HCV Screening in Emergency Department

Not Applicable

Completed

• Conditions: Hiv; Hepatitis C
• Interventions: Diagnostic Test: HIV and HCV screening

• Registration Number: NCT03595527
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study First Submitted: 2018-07-05
• Study Start: 2018-07-10
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-23
• Primary Completion: 2019-10-10
• Study Completion: 2020-10-10
• Results First Submitted: 2022-02-21
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Results First Posted: 2023-02-10
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients consulting in the emergency room	HIV and HCV screening	Patients consulting in the emergency room.

Primary Outcome Measures

Name	Time	Method
Prevalence	10 months	Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)

Secondary Outcome Measures

Name	Time	Method
Prevalence Among Baby-boomers	10 months	Determine the prevalence of new cases of HCV among "baby boomers" (1945 - 1975)
Opt-out	10 months	Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER
Initial Workup	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
Cascade of Care	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)

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada