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

Wellness Wheel Medical Clinic

Status: Enrolling

Conditions: Syphilis; HIV Infections

Treatments: Diagnostic Test: Reveal Rapid TP (from MedMira)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05863117

NFL-CBD-0

Details and patient eligibility

About

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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)