Clinical trial NCT06893159: Ayaangwaamiziwin Initiative: Carefulness and Preparedness
Official title: 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"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Point-of-Care Testing
HIV
Syphilis
Keywords: HIV
syphilis
Point-of-care
Point-of-care testing
POC testing
Community-based
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Screening for HIV and syphilis infection using 3 point-of-care devices by healthcare providers and non-healthcare providers at community-based clinical sites.
Primary purpose: DIAGNOSTIC

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, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities.

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, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities.

The study aims to recruit 10,000 people who are attending clinics for routine sexually transmitted and blood-borne testing in those provinces with opportunities for them to receive immediate treatment for syphilis, and culturally appropriate care and treatment for syphilis and HIV.

The primary objective is develop, implement and evaluate community-based models for "testing, treatment and linkages to care" for HIV and syphilis for those who are undiagnosed and underserved in the Prairie provinces.

The secondary objectives are:

Evaluate diagnostic performance of the investigational syphilis standalone POC test to standard testing.

Test the accuracy and usability of the investigational syphilis standalone POC test by intended users.

Assess the impact of POC testing on time to diagnosis, treatment, and connect to a clinical provider.

Investigate the feasibility and acceptability of the POC test among healthcare providers and at-risk populations.

Examine the acceptability of syphilis and HIV POC tests among at-risk and underserved populations.

Critical to the success of this, the study will engage and support people with lived experiences, peer navigators and leaders from community-based agencies to be involved in all aspects of this work.

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:

Primary outcomes:
measure: Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis)
timeFrame: 3 years
Secondary outcomes:
measure: Time to Diagnosis, Treatment, and Linkage to HIV Care Following Point-of-Care Testing vs. Standard Testing
timeFrame: 3 years
measure: Proportion of Patient Consenting vs. Declining (Patient Acceptability of Point-of-Care Testing )
timeFrame: 3 years
measure: Descriptive Analysis of Healthcare Provider Feasibility and Acceptability of Point-of-Care Testing
timeFrame: 3 years
measure: Descriptive Analysis of Patient Experience and Satisfaction of Point-of-Care Testing
timeFrame: 3 years
measure: Demographic Associations with Syphilis and HIV Point-of-Care Test Outcomes (Reactive vs. Non-Reactive Results)
timeFrame: 3 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Radius Community Health & Healing
state: Alberta
city: Edmonton
country: Canada
facility: StreetWorks
state: Alberta
city: Grande Prairie
country: Canada
facility: Northreach Society
state: Alberta
city: Winnipeg
country: Canada
facility: Siloam Mission
state: Manitoba
city: Winnipeg
country: Canada
facility: Ka Ni Kanichihk
state: Manitoba
city: Winnipeg
country: Canada
facility: Nine Circles Community Health Centre
state: Manitoba
city: Regina
country: Canada
facility: All Nations Hope Network
state: Saskatchewan
city: Regina
country: Canada
facility: Wellness Wheel Clinic
state: Saskatchewan
Study officials:
References: