Hepatitis C, Hiv
Conditions
Keywords
Screening, Linkage to care
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.
Interventions
DIAGNOSTIC_TESTHIV and HCV screening
HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott
Sponsors
Ministere de la Sante et des Services Sociaux
Gilead Sciences
Merck Sharp & Dohme LLC
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 73 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence | 10 months | Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada
Participant flow
Recruitment details
6350 patients were informed of the screening program.
Participants by arm
| Arm | Count |
|---|---|
| Patients Informed of the Screening Program 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 | 6,350 |
| Total | 6,350 |
Baseline characteristics
| Characteristic | Patients Informed of the Screening Program | — |
|---|---|---|
| Age, Continuous | 41 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 6350 participants | — |
| Sex: Female, Male Female | 3366 Participants | — |
| Sex: Female, Male Male | 2984 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6,350 |
| other Total, other adverse events | 0 / 6,350 |
| serious Total, serious adverse events | 0 / 6,350 |
Outcome results
Primary
Prevalence
Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases)
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Screened for HIV | Prevalence | Overall diagnoses | 78 Participants |
| Patients Screened for HIV | Prevalence | New diagnoses | 2 Participants |
| Patients Screened for HCV | Prevalence | Overall diagnoses | 118 Participants |
| Patients Screened for HCV | Prevalence | New diagnoses | 9 Participants |
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)
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Screened for HIV | Cascade of Care | 1 Participants |
| Patients Screened for HCV | Cascade of Care | 2 Participants |
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
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Screened for HIV | Initial Workup | 2 Participants |
| Patients Screened for HCV | Initial Workup | 3 Participants |
Secondary
Opt-out
Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER
Time frame: 10 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Screened for HIV | Opt-out | 1479 Participants |
| Patients Screened for HCV | Opt-out | 1487 Participants |
Secondary
Prevalence Among Baby-boomers
Determine the prevalence of new cases of HCV among baby boomers (1945 - 1975)
Time frame: 10 months
Population: Baby boomers (1945-1975)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Screened for HIV | Prevalence Among Baby-boomers | 7 Participants |