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

NCT05863117 | Unknown

• 1 other identifier: NFL-CBD-0
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 2

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. 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. 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. 3.Time to diagnosis
4. 4.Time to treatment
5. 5.Number of contacts exposed to untreated infections
6. 6.For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV
7. 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. 8.Health care provider experiences of feasibility and acceptability of the POCT used in this pilot
9. 9.Client acceptability and experiences with POCT in this pilot
10. 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.

Conditions

Syphilis; HIV Infections

Keywords

point of care testing

Outcome Measures

Primary Outcomes (3)

• Syphilis-Comparison between point of care testing and serology testing for Syphilis and 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 syphilis POCT.

  12-18 months

• HIV- Comparison between point of care testing and serology testing for Syphilis and HIV

  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

  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 Outcomes (8)

• Time to diagnosis-Clinical utility of POCT for management and follow up of Syphilis and HIV

  12-18 months

• Evaluate the acceptability and feasibility of POCT for syphilis and HIV

  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.

  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.

  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.

  12-18 months

Interventions

Reveal Rapid TP (from MedMira) DIAGNOSTIC_TEST

Point of care tests for HIV and Syphilis

Also known as: INSTI HIV-1/2 HIV test, INSTI Multiplex HIV-1/2 Syphilis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ° Less than 16 years, unable to provide signed informed consent (e.g., intoxicated)

Sponsors & Collaborators

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

Study Sites (2)

Queen City Wellness Pharmacy

Regina, Saskatchewan, S4P 0H7, Canada

RECRUITING

Wellness Wheel Medical Clinic

Regina, Saskatchewan, S4T0L6, Canada

RECRUITING

MeSH Terms

Conditions

Syphilis; HIV Infections

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Stuart Skinner, MD

  Saskatchewan Health Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikki Williamson, RN

CONTACT

1-306-526-7350; nikki.williamson@wellnesswheelclinic.ca

Susanne Nicolay, RN

CONTACT

1-306-520-2846; susanne.nicolay@wellnesswheelclinic.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 17, 2023
• Study Start: February 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)