Ayaangwaamiziwin Initiative: Carefulness and Preparedness

NAActive, not recruitingINTERVENTIONAL
Enrollment

10,000

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

March 31, 2028

Conditions
Point-of-Care TestingHIVSyphilis
Interventions
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."

Trial Locations (8)

T5H 2J2

Radius Community Health & Healing, Edmonton

StreetWorks, Edmonton

T8V 5B6

Northreach Society, Grande Prairie

R3B 1M3

Siloam Mission, Winnipeg

R3G 0R8

Ka Ni Kanichihk, Winnipeg

R3G 0X2

Nine Circles Community Health Centre, Winnipeg

S0G1S0

All Nations Hope Network, Regina

S4T 0L6

Wellness Wheel Clinic, Regina

All Listed Sponsors
lead

Unity Health Toronto

OTHER