Loading clinical trials...
Loading clinical trials...
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.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Queen City Wellness Pharmacy
Regina, Saskatchewan, Canada
Wellness Wheel Medical Clinic
Regina, Saskatchewan, Canada
Start Date
February 1, 2023
Primary Completion Date
July 1, 2024
Completion Date
July 1, 2024
Last Updated
May 17, 2023
1,650
ESTIMATED participants
Reveal Rapid TP (from MedMira)
DIAGNOSTIC_TEST
Lead Sponsor
Wellness Wheel Medical Clinic
Collaborators
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330