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Ayaangwaamiziwin Initiative: Carefulness and Preparedness

NCT06893159 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Point-of-Care Testing
  • HIV
  • Syphilis

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.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2027-12-31
Completion
2028-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06893159 on ClinicalTrials.gov