Ayaangwaamiziwin Initiative: Carefulness and Preparedness (AI)

Unity Health Toronto

Status: Active, not recruiting

Conditions: Syphilis; Point-of-Care Testing; HIV

Treatments: Device: Multiplo Complete Syphilis (TP/nTP) Antibody Test; Device: INSTI Multiplex HIV-1/2 Syphilis Antibody Test; Device: INSTI HIV-1/2 Antibody Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06893159

REACH-SPOR-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 3 patient groups

Patients

Experimental group

Description:

Patients will be anyone presenting at the community site clinics for regular STI testing

Treatment:

Device: INSTI Multiplex HIV-1/2 Syphilis Antibody Test

Device: INSTI HIV-1/2 Antibody Test

Device: Multiplo Complete Syphilis (TP/nTP) Antibody Test

Healthcare Professionals

No Intervention group

Description:

Healthcare professionals (e.g., nurses) that will conduct patient intake, consent patients, provide POC testing (test operators), and provide treatment and linkage to care where necessary.

Non-Healthcare Professionals

No Intervention group

Description:

Non-Healthcare Professionals (e.g., health navigators that are peers with lived experiences) that will conduct community outreach, and for sites that are doing non-healthcare professional testing, the health navigators will conduct patient intake, consent patients, provide POC testing (test operators), and link patients to treatment where necessary.