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ACTIVE NOT RECRUITING

NCT06893159

Ayaangwaamiziwin Initiative: Carefulness and Preparedness

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

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.

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"

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10000

Start Date

2025-02-01

Completion Date

2028-03

Last Updated

2025-03-25

Healthy Volunteers

Yes

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.

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:

Locations (8)

Radius Community Health & Healing

Edmonton, Alberta, Canada

StreetWorks

Edmonton, Alberta, Canada

Northreach Society

Grande Prairie, Alberta, Canada

Siloam Mission

Winnipeg, Manitoba, Canada

Ka Ni Kanichihk

Winnipeg, Manitoba, Canada

Nine Circles Community Health Centre

Winnipeg, Manitoba, Canada

All Nations Hope Network

Regina, Saskatchewan, Canada

Wellness Wheel Clinic

Regina, Saskatchewan, Canada

Clinical Research Directory

Ayaangwaamiziwin Initiative: Carefulness and Preparedness

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (8)