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

Sponsor
Wellness Wheel Medical Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05863117
Collaborator
CIHR Canadian HIV Trials Network (Other), University of Saskatchewan (Other), Saskatchewan Health Authority - Regina Area (Other)
1,650
2
17
825
48.7

Study Details

Study Description

Brief 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:

  3. Time to diagnosis

  4. Time to treatment

  5. Number of contacts exposed to untreated infections

  6. For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV

  7. 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:

  8. Health care provider experiences of feasibility and acceptability of the POCT used in this pilot

  9. Client acceptability and experiences with POCT in this pilot

  10. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Reveal Rapid TP (from MedMira)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1650 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV [12-18 months]

    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.

  2. HIV- Comparison between point of care testing and serology testing for Syphilis and HIV [12-18 months]

    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.

  3. Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV [12-18 months]

    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.

Secondary Outcome Measures

  1. Time to diagnosis-Clinical utility of POCT for management and follow up of Syphilis and HIV [12-18 months]

    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

  2. Evaluate the acceptability and feasibility of POCT for syphilis and HIV [12-18 months]

    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

  3. 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. [12-18 months]

    To evaluate the acceptability and feasibility of HIV alone among at-risk and/or hard to reach populations

  4. 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. [12-18 months]

    To evaluate the acceptability and feasibility of combined syphilis/HIV POCT among at-risk and/or hard to reach populations

  5. 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. [12-18 months]

    To evaluate the acceptability and feasibility of syphilis alone, among at-risk and/or hard to reach populations

  6. Time to treatment-Clinical utility of POCT for management and follow up of Syphilis and HIV [12-18 months]

    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

  7. Number of contacts-Clinical utility of POCT for management and follow up of Syphilis and HIV [12-18 months]

    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

  8. Time to connection-Clinical utility of POCT for management and follow up of Syphilis and HIV [12-18 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen City Wellness Pharmacy Regina Saskatchewan Canada S4P 0H7
2 Wellness Wheel Medical Clinic Regina Saskatchewan Canada S4T0L6

Sponsors and Collaborators

  • Wellness Wheel Medical Clinic
  • CIHR Canadian HIV Trials Network
  • University of Saskatchewan
  • Saskatchewan Health Authority - Regina Area

Investigators

  • Principal Investigator: Stuart Skinner, MD, Saskatchewan Health Region

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wellness Wheel Medical Clinic
ClinicalTrials.gov Identifier:
NCT05863117
Other Study ID Numbers:
  • NFL-CBD-0
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wellness Wheel Medical Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023