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"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Unity Health Toronto
- Enrollment
- 10,000
- Locations
- 8
- Primary Endpoint
- Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Test participants:
- •Inclusion Criteria:
- •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.
Exclusion Criteria
- •< 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.
- •Inclusion criteria:
- •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
- •Exclusion criteria:
- •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.
- •Inclusion criteria:
- •Regulated healthcare professional
- •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
- •Exclusion criteria:
Arms & Interventions
Patients
Patients will be anyone presenting at the community site clinics for regular STI testing
Intervention: INSTI Multiplex HIV-1/2 Syphilis Antibody Test (Device)
Patients
Patients will be anyone presenting at the community site clinics for regular STI testing
Intervention: Multiplo Complete Syphilis (TP/nTP) Antibody Test (Device)
Patients
Patients will be anyone presenting at the community site clinics for regular STI testing
Intervention: INSTI HIV-1/2 Antibody Test (Device)
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.
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.
Outcomes
Primary Outcomes
Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis)
Time Frame: 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 Outcomes
- 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)