Ayaangwaamiziwin Initiative: Carefulness and Preparedness

NCT06893159 | Active Not Recruiting

• 1 other identifier: REACH-SPOR-001
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

HIV; syphilis; Point-of-care; Point-of-care testing; POC testing; Community-based

Outcome Measures

Primary Outcomes (1)

• Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis)

  Diagnostic performance of POC T Pallidum antibody and non-T Pallidum antibody test results will be compared to standard laboratory testing results for each marker, and test performance characteristics with 95% binomial confidence intervals will be calculated for sensitivity and specificity. In addition, diagnostic performance for TP antibody detection will be stratified by RPR titre (non-reactive, 1:1, 1:2, 1:4, \>1:8 dilutions). Serial, parallel serology will be collected at the time of every syphilis POCT. Serology is the gold standard to diagnose syphilis and aids in determining staging and thus, treatment. Serial testing will aid whether syphilis POCT may be utilized in a more comprehensive manner, to possibly replace serology in some settings where access may be a challenge.

  3 years

Secondary Outcomes (5)

• Time to Diagnosis, Treatment, and Linkage to HIV Care Following Point-of-Care Testing vs. Standard Testing

  3 years

• Proportion of Patient Consenting vs. Declining (Patient Acceptability of Point-of-Care Testing )

  3 years

• Descriptive Analysis of Healthcare Provider Feasibility and Acceptability of Point-of-Care Testing

  3 years

• Descriptive Analysis of Patient Experience and Satisfaction of Point-of-Care Testing

  3 years

• Demographic Associations with Syphilis and HIV Point-of-Care Test Outcomes (Reactive vs. Non-Reactive Results)

  3 years

Study Arms (3)

Patients

EXPERIMENTAL

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

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

Healthcare Professionals

NO INTERVENTION

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

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.

Interventions

INSTI HIV-1/2 Antibody Test DEVICE

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.

Patients

INSTI Multiplex HIV-1/2 Syphilis Antibody Test DEVICE

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.

Patients

Multiplo Complete Syphilis (TP/nTP) Antibody Test DEVICE

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.

Patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals \> 16 years old accessing STBBI testing at specific locations
• 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.

You may not qualify if:

• \< 16 years
• 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.
• Individuals \> 18 years old
• Are able to read/understand English or French
• Are able to provide informed consent
• Are paid employees of the study site(s)
• Are able to perform the study procedures outlined in the protocol
• Individuals \< 18 years old
• Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study
• 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.
• Regulated healthcare professional
• Are able to read/understand English or French
• Are able to provide informed consent

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (8)

Radius Community Health & Healing

Edmonton, Alberta, T5H 2J2, Canada

Location

StreetWorks

Edmonton, Alberta, T5H 2J2, Canada

Location

Northreach Society

Grande Prairie, Alberta, T8V 5B6, Canada

Location

Siloam Mission

Winnipeg, Manitoba, R3B 1M3, Canada

Location

Ka Ni Kanichihk

Winnipeg, Manitoba, R3G 0R8, Canada

Location

Nine Circles Community Health Centre

Winnipeg, Manitoba, R3G 0X2, Canada

Location

All Nations Hope Network

Regina, Saskatchewan, S0G1S0, Canada

Location

Wellness Wheel Clinic

Regina, Saskatchewan, S4T 0L6, Canada

Location

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Screening for HIV and syphilis infection using 3 point-of-care devices by healthcare providers and non-healthcare providers at community-based clinical sites.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 25, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)