Syphilis and HIV Point of Care Testing (POCT) in Saskatchewan

Study Overview
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Brief Summary
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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: 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. 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 to treatment Number of contacts exposed to untreated infections For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV 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: Health care provider experiences of feasibility and acceptability of the POCT used in this pilot Client acceptability and experiences with POCT in this pilot 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.

Official Title
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Syphilis and HIV Point of Care Testing (POCT) to Improve Access to Testing Among Inner City, Remote, Rural and Hard to Reach Populations in Saskatchewan

Conditions
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Syphilis, HIV Infections

Intervention / Treatment
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* Diagnostic Test: Reveal Rapid TP (from MedMira)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1650 consecutive individuals > 16 years accessing STBBI testing at specific locations and able to provide informed consent. PLWH and persons who are syphilis positive may also eligible to participate. Exclusion Criteria: ° Less than 16 years, unable to provide signed informed consent (e.g., intoxicated)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Reveal Rapid TP (from MedMira)|Point of care tests for HIV and Syphilis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syphilis-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. | 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. | 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. | 12-18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 12-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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point of care testing