Clinical trial NCT05863117: Syphilis and HIV Point of Care Testing (POCT) in Saskatchewan
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Syphilis
HIV Infections
Keywords: point of care testing
Lead sponsor: Wellness Wheel Medical Clinic
Sponsor class: OTHER
Collaborators: name: CIHR Canadian HIV Trials Network
name: University of Saskatchewan
name: Saskatchewan Health Authority - Regina Area
First posted: 2023-05-17
Enrollment: 1650
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
timeFrame: 12-18 months
measure: HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
timeFrame: 12-18 months
measure: Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
timeFrame: 12-18 months
Secondary outcomes:
measure: Time to diagnosis-Clinical utility of POCT for management and follow up of Syphilis and HIV
timeFrame: 12-18 months
measure: Evaluate the acceptability and feasibility of POCT for syphilis and HIV
timeFrame: 12-18 months
measure: 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.
timeFrame: 12-18 months
measure: 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.
timeFrame: 12-18 months
measure: 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.
timeFrame: 12-18 months
measure: Time to treatment-Clinical utility of POCT for management and follow up of Syphilis and HIV
timeFrame: 12-18 months
measure: Number of contacts-Clinical utility of POCT for management and follow up of Syphilis and HIV
timeFrame: 12-18 months
measure: Time to connection-Clinical utility of POCT for management and follow up of Syphilis and HIV
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Queen City Wellness Pharmacy
state: Saskatchewan
city: Regina
country: Canada
facility: Wellness Wheel Medical Clinic
state: Saskatchewan
Study officials:
affiliation: Saskatchewan Health Region
name: Stuart Skinner, MD
role: PRINCIPAL_INVESTIGATOR
References: