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

HIV Infections Clinical Trial

— SHIVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863117
• Other study ID #: NFL-CBD-0
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Wellness Wheel Medical Clinic
• Contact: Nikki Williamson, RN
• Phone: 1-306-526-7350
• Email: nikki.williamson[@]wellnesswheelclinic.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1650
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infections
• Syphilis

Intervention

Diagnostic Test:
• Reveal Rapid TP (from MedMira)
Point of care tests for HIV and Syphilis

Locations

Country	Name	City	State
Canada	Queen City Wellness Pharmacy	Regina	Saskatchewan
Canada	Wellness Wheel Medical Clinic	Regina	Saskatchewan

Sponsors (4)

Lead Sponsor	Collaborator
Wellness Wheel Medical Clinic	CIHR Canadian HIV Trials Network, Saskatchewan Health Authority - Regina Area, University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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