Recruiting

POCT

Sponsor:

Wellness Wheel Medical Clinic

Code:

NCT05863117

Conditions

Syphilis

HIV Infections

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Reveal Rapid TP (from MedMira)

Study Details

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:

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.

Conditions

Syphilis

HIV Infections

Study ID

NCT05863117

Start date

Feb 1, 2023

Status verified date

May, 2023

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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 Design

Enrollment

1650 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Interventions

Reveal Rapid TP (from MedMira)

Point of care tests for HIV and Syphilis

Primary outcome measure

  • Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV [ Time Frame: 12-18 months ]
  • HIV- Comparison between point of care testing and serology testing for Syphilis and HIV [ Time Frame: 12-18 months ]
  • Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV [ Time Frame: 12-18 months ]

Central Contacts and Locations

Locations

Queen City Wellness Pharmacy

Recruiting

Regina, Saskatchewan, Canada, S4P 0H7

Contacts

Wellness Wheel Medical Clinic

Recruiting

Regina, Saskatchewan, Canada, S4T0L6

Contacts

More Information

Sponsor

Wellness Wheel Medical Clinic

Last update posted

May 17, 2023

Last verified

May, 2023

Keywords

  • point of care testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wellness Wheel Medical Clinic on 2023-05-17.