NCT06893159Active, not recruiting
Ayaangwaamiziwin Initiative: Carefulness and Preparedness
REACHing Underserved and Undiagnosed Populations Living with Syphilis and HIV in Alberta, Saskatchewan, Manitoba and Northern Communities: "Test, Treat and Linkage to Culturally Appropriate Care"
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
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, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10000 (estimated)
- First submitted
- 27 Feb 2025
- Start date
- 1 Feb 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Unity Health Toronto
- Diseases
- HIV
- NCT number
- NCT06893159
What you commit to
- Study type: Interventional
- Planned participants: 10000
- From 1 Feb 2025 to the primary completion date, Dec 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study
Lab values
- 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.
Age
- \< 16 years
- Individuals \< 18 years old
Who the study is looking for
- 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.
- 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
- 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
Criteria the registry did not label
- Test participants:
Age in the registry: 16 years to - · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| StreetWorks Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Radius Community Health & Healing Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Northreach Society Coordinator of this site? Confirm its status | Grande Prairie | Canada | Unknown status |
| All Nations Hope Network Coordinator of this site? Confirm its status | Regina | Canada | Unknown status |
| Wellness Wheel Clinic Coordinator of this site? Confirm its status | Regina | Canada | Unknown status |
| Ka Ni Kanichihk Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Nine Circles Community Health Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Siloam Mission Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.