Trial Outcomes & Findings for Universal HIV Screening and Targeted HCV Screening in Emergency Department (NCT NCT03595527)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6350 participants

Primary outcome timeframe

10 months

Results posted on

2023-02-10

Participant Flow

6350 patients were informed of the screening program.

Participant milestones

Participant milestones
Measure	Patients Informed of the Screening Program Patients consulting in the emergency room who were informed about the screening program.
Overall Study STARTED	6350
Overall Study Patients Screened for HIV	3905
Overall Study Patients Screened for HCV	3910
Overall Study COMPLETED	6350
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Informed of the Screening Program n=6350 Participants Patients consulting in the emergency room and informed of the screening program. HIV and HCV screening: HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott
Age, Continuous	41 years n=6350 Participants
Sex: Female, Male Female	3366 Participants n=6350 Participants
Sex: Female, Male Male	2984 Participants n=6350 Participants
Region of Enrollment Canada	6350 participants n=6350 Participants

PRIMARY outcome

Timeframe: 10 months

Population: Overall diagnoses: New and known diagnoses among patients consulting in the emergency room who were informed of the screening program New diagnosess: New diagnoses among patients patients consulting in the emergency room who were tested

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

Outcome measures

Outcome measures
Measure	Patients Screened for HIV n=6350 Participants Patients consulting in the emergency room who were informed of the screening program. HIV screening: ARCHITECT HIV Ag/Ab Combo, Abbott	Patients Screened for HCV n=6350 Participants Patients consulting in the emergency room who were informed of the screening program. HCV screening: ARCHITECT Anti-HCV, Abbott
Prevalence Overall diagnoses	78 Participants	118 Participants
Prevalence New diagnoses	2 Participants	9 Participants

SECONDARY outcome

Timeframe: 10 months

Population: Baby boomers (1945-1975)

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

Outcome measures

Outcome measures
Measure	Patients Screened for HIV n=1818 Participants Patients consulting in the emergency room who were informed of the screening program. HIV screening: ARCHITECT HIV Ag/Ab Combo, Abbott	Patients Screened for HCV Patients consulting in the emergency room who were informed of the screening program. HCV screening: ARCHITECT Anti-HCV, Abbott
Prevalence Among Baby-boomers	7 Participants	—

SECONDARY outcome

Timeframe: 10 months

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

Outcome measures

Outcome measures
Measure	Patients Screened for HIV n=6350 Participants Patients consulting in the emergency room who were informed of the screening program. HIV screening: ARCHITECT HIV Ag/Ab Combo, Abbott	Patients Screened for HCV n=6350 Participants Patients consulting in the emergency room who were informed of the screening program. HCV screening: ARCHITECT Anti-HCV, Abbott
Opt-out	1479 Participants	1487 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients Screened for HIV n=2 Participants Patients consulting in the emergency room who were informed of the screening program. HIV screening: ARCHITECT HIV Ag/Ab Combo, Abbott	Patients Screened for HCV n=9 Participants Patients consulting in the emergency room who were informed of the screening program. HCV screening: ARCHITECT Anti-HCV, Abbott
Initial Workup	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Patients Screened for HIV n=2 Participants Patients consulting in the emergency room who were informed of the screening program. HIV screening: ARCHITECT HIV Ag/Ab Combo, Abbott	Patients Screened for HCV n=9 Participants Patients consulting in the emergency room who were informed of the screening program. HCV screening: ARCHITECT Anti-HCV, Abbott
Cascade of Care	1 Participants	2 Participants

Adverse Events

Patients Consulting in the Emergency Room

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valréie Martel-Laferrière, MD

Centre hospitalier de l'Université de Montréal

Phone: 5148908000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place