Ayaangwaamiziwin Initiative: Carefulness and Preparedness (AI)

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"

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV; Syphilis; Point-of-Care Testing
• Intervention / Treatment: Device: INSTI HIV-1/2 Antibody Test; Device: INSTI Multiplex HIV-1/2 Syphilis Antibody Test; Device: Multiplo Complete Syphilis (TP/nTP) Antibody Test

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.

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 2J2
      • Radius Community Health & Healing
    • Edmonton, Alberta, Canada, T5H 2J2
      • StreetWorks
    • Grande Prairie, Alberta, Canada, T8V 5B6
      • Northreach Society
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3B 1M3
      • Siloam Mission
    • Winnipeg, Manitoba, Canada, R3G 0R8
      • Ka Ni Kanichihk
    • Winnipeg, Manitoba, Canada, R3G 0X2
      • Nine Circles Community Health Centre
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S0G1S0
      • All Nations Hope Network
    • Regina, Saskatchewan, Canada, S4T 0L6
      • Wellness Wheel Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Patients will be anyone presenting at the community site clinics for regular STI testing	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.
No Intervention: Healthcare Professionals; 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.
No Intervention: Non-Healthcare Professionals; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Diagnosis, Treatment, and Linkage to HIV Care Following Point-of-Care Testing vs. Standard Testing	Assess the time to diagnosis, time to treatment, and time to HIV care linkage following point-of-care testing for syphilis and HIV compared to standard laboratory testing. Time to diagnosis and treatment will be measured in days from test administration to diagnosis and from diagnosis to treatment, respectively. For HIV, time to linkage to care will be measured in days from diagnosis to first consultation with an infectious disease specialist. Data will be stratified by age, gender, and testing location, and analyzed using survival analysis or Poisson/negative binomial regression. Comparisons will be made between POC and standard testing with statistical significance determined by a p-value of <0.05.	3 years
Proportion of Patient Consenting vs. Declining (Patient Acceptability of Point-of-Care Testing )	To evaluate the acceptability and feasibility of POC among different populations for syphilis (and HIV if applicable) among at risk and underserved populations, specifically patient acceptability and experiences with POC. Patient acceptability will be calculated as the proportion of individuals consenting to POCT divided by the total number of participants offered POC testing. To determine differences between participants consenting and those declining POC testing, age, gender, and testing location will be compared using chi-square for categorical variables and Mann-Whitney U test for age. A two-sided p value of < 0.05 will be considered statistically significant.	3 years
Descriptive Analysis of Healthcare Provider Feasibility and Acceptability of Point-of-Care Testing	Healthcare providers will complete a survey after point-of-care testing assessing their experience using the test (e.g., ease of use, ease of interpretation of results). A descriptive analysis of healthcare provider experience survey will be conducted.	3 years
Descriptive Analysis of Patient Experience and Satisfaction of Point-of-Care Testing	Patients will complete a survey after point-of-care testing assessing their experience (e.g., comfort levels, recommend to others, ease of testing process). A descriptive analysis of the patient experience survey will be completed and stratified by negative and positive results by test type.	3 years
Demographic Associations with Syphilis and HIV Point-of-Care Test Outcomes (Reactive vs. Non-Reactive Results)	Analyze the associations between demographic factors (such as age, gender, and testing location) and syphilis and HIV point-of-care test outcomes, focusing on the correlation between demographics and reactive versus non-reactive test results. Chi-square analysis will be used to assess these associations, with stratification by POC test type when sample sizes allow. A two-sided p-value of <0.05 will be considered statistically significant.	3 years

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Community-based; syphilis; Point-of-care; Point-of-care testing; POC testing
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Sexually Transmitted Diseases, Bacterial; Treponemal Infections; Syphilis; Immunologic Factors; Physiological Effects of Drugs; Antibodies; Immunoglobulins
• Other Study ID Numbers: REACH-SPOR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No