NCT06893159

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"

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Point-of-Care Testing
• HIV
• Syphilis

Interventions

Type	Name	Description
DEVICE	INSTI HIV-1/2 Antibody Test	The INSTI HIV-1/HIV-2 Antibody Test is a single use, rapid, in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and/or Type 2 (HIV-1/HIV-2) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The test is intended for use by trained personnel in point of care and laboratory situations to aid in the diagnosis of HIV infections. If multiple rapid HIV tests are available, this test is suitable for use in appropriate multi-test algorithms.
DEVICE	INSTI Multiplex HIV-1/2 Syphilis Antibody Test	The INSTI MULTIPLEX HIV-1/2 Syphilis Ab Test is a single use, rapid, flow-through in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1/ Type 2 and Treponema pallidum in human fingerstick blood and serum. The INSTI Multiplex Test is intended as an aid in the diagnosis of HIV1/2 and Syphilis infections in patients with signs and symptoms of HIV and Syphilis. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than one minute. Although suitable for near-patient point-of-care (POC) testing, the INSTI Multiplex Test is not suitable for self-testing.
DEVICE	Multiplo Complete Syphilis (TP/nTP) Antibody Test	Multiplo Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP) is a single use, manually performed, visually interpreted, qualitative immunoassay based on Rapid Vertical Flow Technology® for the detection of antibodies to Treponema pallidum (TP), the causative agent of syphilis, and to nontreponemal (nTP; \[RPR titer ≥ 1:8\]) antigens in human serum, plasma, or fingerstick whole blood specimens. Nontreponemal antibodies are called reagins and they are generated after the tissue damage caused by syphilis infection. Multiplo® TP/nTP is intended for use by healthcare professionals as an aid in the diagnosis of active syphilis infection.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

8 sites across 1 country: Canada