Universal HIV Screening and Targeted HCV Screening in Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Universal HIV Screening and Targeted HCV Screening in Emergency Department

Conditions
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Hepatitis C, Hiv

Intervention / Treatment
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* Diagnostic Test: HIV and HCV screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients consulting in the emergency room<br>Patients consulting in the emergency room. | Diagnostic Test: HIV and HCV screening<br>* HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence | 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 | Determine the prevalence of new cases of HCV among baby boomers (1945 - 1975) | 10 months | 
| Opt-out | Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER | 10 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Linkage to care