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

May 8, 2023 updated by: Wellness Wheel Medical Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
Time Frame: 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.
12-18 months
HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Time Frame: 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.
12-18 months
Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
Time Frame: 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.
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
Time Frame: 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
12-18 months
Evaluate the acceptability and feasibility of POCT for syphilis and HIV
Time Frame: 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
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.
Time Frame: 12-18 months
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.
Time Frame: 12-18 months
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.
Time Frame: 12-18 months
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
Time Frame: 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
12-18 months
Number of contacts-Clinical utility of POCT for management and follow up of Syphilis and HIV
Time Frame: 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
12-18 months
Time to connection-Clinical utility of POCT for management and follow up of Syphilis and HIV
Time Frame: 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.
12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellness Wheel Medical Clinic

Collaborators

University of Saskatchewan
Saskatchewan Health Authority - Regina Area
CIHR Canadian HIV Trials Network

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFL-CBD-0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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