The goal of this clinical trial is to learn about Syphilis and HIV point of care testing among inner city, remote, rural and hard to reach populations in Saskatchewan. The main question\[s\] it aims to answer are: 1. To evaluate the field diagnostic test performance (e.g. sensitivity, specificity, predictive values) of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT, HIV POCT and dual syphilis and HIV POCT. 2. To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically: 1. Time to diagnosis 2. Time to treatment 3. Number of contacts exposed to untreated infections 4. For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV 3. To evaluate the acceptability and feasibility of POCT among different populations for syphilis and HIV among at risk and/or hard to reach populations, specifically: 1. Health care provider experiences of feasibility and acceptability of the POCT used in this pilot 2. Client acceptability and experiences with POCT in this pilot 3. Client preferences for test offered (syphilis only, HIV only, or dual test of HIV and syphilis 4. To evaluate the acceptability and feasibility of syphilis alone, HIV alone or combined syphilis/HIV POCT among at-risk and/or hard to reach populations. Participants will be assessed for risk factors that may increase risk of infectious disease such as substance use and sexual habits. They will then be offered a choice of 1 of 3 POCT(Syphilis alone, HIV alone or a dual HIV/Syphilis test). Serology will be obtained for sexually transmitted and blood born infections (STBBI's) and then the point of care test (POCT) will be completed. Following the testing the participant will complete a short survey on their experience.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,650
Point of care tests for HIV and Syphilis
Queen City Wellness Pharmacy
Regina, Saskatchewan, Canada
RECRUITINGWellness Wheel Medical Clinic
Regina, Saskatchewan, Canada
RECRUITINGSyphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT.
Time frame: 12-18 months
HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
HIV- To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for HIV POCT.
Time frame: 12-18 months
Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Dual HIV/Syphilis-To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for dual syphilis and HIV POCT.
Time frame: 12-18 months
Time to diagnosis-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically: Time to diagnosis
Time frame: 12-18 months
Evaluate the acceptability and feasibility of POCT for syphilis and HIV
To evaluate the acceptability and feasibility by using a patient experience survey of POCT among different populations for syphilis and HIV among at risk and/or hard to reach populations, specifically: Health care provider experiences of feasibility and acceptability of the POCT used in this pilot b) Client acceptability and experiences with POCT in this pilot c) Client preferences for test offered (syphilis only, HIV only, or dual test of HIV and syphilis
Time frame: 12-18 months
HIV-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
To evaluate the acceptability and feasibility of HIV alone among at-risk and/or hard to reach populations
Time frame: 12-18 months
Dual HIV/Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
To evaluate the acceptability and feasibility of combined syphilis/HIV POCT among at-risk and/or hard to reach populations
Time frame: 12-18 months
Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.
To evaluate the acceptability and feasibility of syphilis alone, among at-risk and/or hard to reach populations
Time frame: 12-18 months
Time to treatment-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically:Time to treatment
Time frame: 12-18 months
Number of contacts-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically: Number of contacts exposed to untreated infections
Time frame: 12-18 months
Time to connection-Clinical utility of POCT for management and follow up of Syphilis and HIV
To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically: For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV.
Time frame: 12-18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.