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| Name | Class |
|---|---|
| Ministere de la Sante et des Services Sociaux | OTHER |
| Gilead Sciences | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients consulting in the emergency room | Experimental | Patients consulting in the emergency room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV and HCV screening | Diagnostic Test | HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 3E4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35042704 | Derived | Martel-Laferriere V, Baril JG, Alarie I, Leblanc J, Cote J, Jourdenais E, Horth D, Lambert G, Tremblay C. Opt-out universal HCV and HIV screening in a Canadian emergency room: a cross-sectional study. BMJ Open. 2022 Jan 18;12(1):e048748. doi: 10.1136/bmjopen-2021-048748. |
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6350 patients were informed of the screening program.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Informed of the Screening Program | Patients consulting in the emergency room who were informed about the screening program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence | Prevalence of HIV and HCV among patients who consult at the ER of the CHUM (overall and undiagnosed cases) | 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 | Posted | Count of Participants | Participants | 10 months |
|
10 months
Adverse events were not systematically collected in this cross-sectionnal study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Consulting in the Emergency Room | Patients consulting in the emergency room. HIV and HCV screening: HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valréie Martel-Laferrière, MD | Centre hospitalier de l'Université de Montréal | 5148908000 | valerie.martel-laferriere.med@ssss.gouv.qc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2018 | Feb 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069078 | Seroconversion |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Prevalence Among Baby-boomers | Determine the prevalence of new cases of HCV among "baby boomers" (1945 - 1975) | Baby boomers (1945-1975) | Posted | Count of Participants | Participants | 10 months |
|
|
|
| Secondary | Opt-out | Determine the percentage of patients that opted-out of the routine screening for HIV and HCV at the ER | Posted | Count of Participants | Participants | 10 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 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) | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 6,350 |
| 0 |
| 6,350 |
| 0 |
| 6,350 |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |