Point of Care Tests for Syphilis and HIV

NCT04514848 | Completed

• 1 other identifier: Pro00095828
• Study Type: interventional
• Target: 1,526
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the performance of two point-of-care dual syphilis and HIV tests \[Multiplo TP/HIV test (MedMira Inc, Halifax, Nova Scotia) and the INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test (bioLytical Laboratories Inc., Richmond, BC)\]. In addition to standard syphilis and HIV testing, point-of care testing (POCT) will be performed on 1,500 consecutive participants who are being screened for syphilis and HIV and who are at least 16 years old. POCT will be conducted using a fingerprick whole blood specimen. The study will be conducted at multiple sites in Northern Alberta (Canada), a region which is currently experiencing a resurgence of infectious syphilis.

Conditions

Syphilis

Keywords

Point-of-care tests; Rapid tests

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the Multiplo TP/HIV test and the INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test in field settings

  Against standard laboratory tests for syphilis and HIV

  Two weeks

Secondary Outcomes (2)

• Time to return for standard test results

  Two weeks

• Number returning for standard test results

  6-12 months

Study Arms (1)

Individuals accessing screening for syphilis and HIV

EXPERIMENTAL

Individuals at risk for syphilis and HIV (e.g. gay and bisexual men, indigenous communities experiencing a resurgence of syphilis, persons who inject drugs, etc) will undergo testing with both POCT and standard laboratory testing. Individuals testing positive for syphilis or HIV on the POCT will be informed that this is a preliminary positive and standard testing will be done. Individuals testing positive for syphilis on POCT may be offered treatment at the time of testing.

Device: INSTI Multiplex HIV-1/2 Syphilis AB test; Device: Multiplo Rapid TP/HIV test

Interventions

INSTI Multiplex HIV-1/2 Syphilis AB test DEVICE

For the detection of antibodies to syphilis and HIV

Individuals accessing screening for syphilis and HIV

Multiplo Rapid TP/HIV test DEVICE

For the detection of antibodies to syphilis and HIV

Individuals accessing screening for syphilis and HIV

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who would routinely be screened for syphilis and HIV

You may not qualify if:

• \< 16 years, unable to provide signed informed consent

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Health services: collaborator
• Canadian Foundation for AIDS Research (CANFAR): collaborator

Study Sites (1)

Ameeta Singh

Edmonton, Alberta, T6J2C2, Canada

Location

MeSH Terms

Conditions

Syphilis

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

Study Design

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

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 17, 2020
• Study Start: July 27, 2020
• Primary Completion: February 11, 2021
• Study Completion: February 14, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)