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

Last updated: May 8, 2023
Sponsor: Wellness Wheel Medical Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gynecological Infections

Hiv

Rash

Treatment

Reveal Rapid TP (from MedMira)

Clinical Study ID

NCT05863117
NFL-CBD-0
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1650 consecutive individuals
  • > 16 years accessing STBBI testing at specific locations and able to provide informedconsent. PLWH and persons who are syphilis positive may also eligible to participate.

Exclusion

Exclusion Criteria:

° Less than 16 years, unable to provide signed informed consent (e.g., intoxicated)

Study Design

Total Participants: 1650
Treatment Group(s): 1
Primary Treatment: Reveal Rapid TP (from MedMira)
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
July 31, 2024

Connect with a study center

  • Queen City Wellness Pharmacy

    Regina, Saskatchewan S4P 0H7
    Canada

    Active - Recruiting

  • Wellness Wheel Medical Clinic

    Regina, Saskatchewan S4T0L6
    Canada

    Active - Recruiting

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