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NCT Number: NCT03595527

Universal HIV Screening and Targeted HCV Screening in Emergency Department

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.

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Key information

Conditions

Hepatitis C Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV HIV Infections Hepatitis Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIV and HCV screening

Diagnostic Test

HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott

Primary outcomes

  1. Prevalence

    Time frame: 10 months

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

Secondary outcomes

  1. Prevalence Among Baby-boomers

    Time frame: 10 months

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

  2. Opt-out

    Time frame: 10 months

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

  3. Initial Workup

    Time frame: 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

  4. Cascade of Care

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Gilead Sciences
  • Merck Sharp & Dohme LLC
  • Ministere de la Sante et des Services Sociaux

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 23, 2018
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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