Ayaangwaamiziwin Initiative: Carefulness and Preparedness

Launched by UNITY HEALTH TORONTO · Mar 17, 2025

Keywords

ClinConnect Summary

The Ayaangwaamiziwin Initiative: Carefulness and Preparedness is a clinical trial aimed at improving the way we test and treat HIV and syphilis in certain communities across Alberta, Manitoba, and Saskatchewan. The goal is to reach 10,000 people in underserved areas by using quick tests that can provide results on the spot. This program not only focuses on testing but also on connecting individuals to the medical care they need. The trial is currently active but not recruiting new participants at this time.

To be eligible for this study, individuals must be over 16 years old and willing to give their consent to participate. Participants will have the opportunity to receive rapid testing for STBBIs (sexually transmitted and blood-borne infections) in various locations. The study will also involve trained community members and healthcare professionals who will help carry out the tests and assist participants throughout the process. This initiative is an important step toward ensuring that more people have access to critical healthcare services in their communities.

Gender

ALL

Eligibility criteria

• Test participants:
• Inclusion Criteria:
• • 1. Individuals \> 16 years old accessing STBBI testing at specific locations
• • 2. 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 Criteria:
• • 1. \< 16 years
• • 2. 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:
• • 1. Individuals \> 18 years old
• • 2. Are able to read/understand English or French
• • 3. Are able to provide informed consent
• • 4. Are paid employees of the study site(s)
• • 5. Are able to perform the study procedures outlined in the protocol
• Exclusion criteria:
• • 1. Individuals \< 18 years old
• • 2. Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study
• • 3. 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:
• • 1. Regulated healthcare professional
• • 2. Are able to read/understand English or French
• • 3. Are able to provide informed consent
• • 4. Are paid employees of the study site(s)
• • 5. Are able to perform the study procedures outlined in the protocol
• Exclusion criteria: