Ayaangwaamiziwin Initiative: Carefulness and Preparedness

Not Applicable

Active, not recruiting

• Conditions: Point-of-Care Testing; HIV; Syphilis

• Registration Number: NCT06893159
• Lead Sponsor: Unity Health Toronto

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.

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 Timeline

• Status Verified: 2025-01
• Study Start: 2025-02-01
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-12
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis)	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Time to Diagnosis, Treatment, and Linkage to HIV Care Following Point-of-Care Testing vs. Standard Testing	3 years	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.
Proportion of Patient Consenting vs. Declining (Patient Acceptability of Point-of-Care Testing )	3 years	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.
Descriptive Analysis of Healthcare Provider Feasibility and Acceptability of Point-of-Care Testing	3 years	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.
Descriptive Analysis of Patient Experience and Satisfaction of Point-of-Care Testing	3 years	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.
Demographic Associations with Syphilis and HIV Point-of-Care Test Outcomes (Reactive vs. Non-Reactive Results)	3 years	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.

Trial Locations

Locations (8)

Siloam Mission; 🇨🇦 Winnipeg, Manitoba, Canada

Ka Ni Kanichihk; 🇨🇦 Winnipeg, Manitoba, Canada

StreetWorks; 🇨🇦 Edmonton, Alberta, Canada

Radius Community Health & Healing; 🇨🇦 Edmonton, Alberta, Canada

Northreach Society; 🇨🇦 Grande Prairie, Alberta, Canada

Nine Circles Community Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada

All Nations Hope Network; 🇨🇦 Regina, Saskatchewan, Canada

Wellness Wheel Clinic; 🇨🇦 Regina, Saskatchewan, Canada