Status:
ACTIVE_NOT_RECRUITING
Ayaangwaamiziwin Initiative: Carefulness and Preparedness
Lead Sponsor:
Unity Health Toronto
Conditions:
Point-of-Care Testing
HIV
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Mani...
Detailed Description
The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Mani...
Eligibility Criteria
Inclusion
- Test participants:
- Individuals \> 16 years old accessing STBBI testing at specific locations
- Able to provide informed consent.
- Due to the number of sites across SK, AB, and MB, the diversity of the sites and local teams and the incremental addition of sites as the project progresses, the total number of participants to be recruited over the duration of the study (3 years), will be 10,000 individuals and there will be no requirement on local sample size, for the participating sites. (Please refer to Risks and Benefits). A competitive recruitment process will be in place and monitored closely throughout the study.
Exclusion
- \< 16 years
- Unable to provide signed informed consent (e.g., intoxicated)
- Non-Healthcare Professional Operators For the purposes of this study, the untrained non-HCP operators are defined as the personnel, including community health navigators who in the opinion of the Principal Investigator are able to perform the study procedures outlined in this protocol and who are employed by the site. These operators will only be using the investigational device in this study - Multiplo® Complete Syphilis point-of-care test.
- Inclusion criteria:
- Individuals \> 18 years old
- Are able to read/understand English or French
- Are able to provide informed consent
- Are paid employees of the study site(s)
- Are able to perform the study procedures outlined in the protocol
- Exclusion criteria:
- Individuals \< 18 years old
- Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study
- Are regulated healthcare professionals including nurses, nurse practitioners, physicians, dentists, pharmacists, and laboratory technologists
- Healthcare Professional Operators For the purposes of this study, the healthcare professionals are defined as the paid personnel who in the opinion of the Principal Investigator are able to perform the study procedures outlined in this protocol and who are employed by the site.
- Inclusion criteria:
- Regulated healthcare professional
- Are able to read/understand English or French
- Are able to provide informed consent
- Are paid employees of the study site(s)
- Are able to perform the study procedures outlined in the protocol
- Exclusion criteria:
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06893159
Start Date
February 1 2025
End Date
March 1 2028
Last Update
March 25 2025
Active Locations (8)
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1
Radius Community Health & Healing
Edmonton, Alberta, Canada, T5H 2J2
2
StreetWorks
Edmonton, Alberta, Canada, T5H 2J2
3
Northreach Society
Grande Prairie, Alberta, Canada, T8V 5B6
4
Siloam Mission
Winnipeg, Manitoba, Canada, R3B 1M3