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Point of Care Tests for Syphilis and HIV

NCT04514848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1526

Last updated 2022-12-14

No results posted yet for this study

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

Interventions

DEVICE

INSTI Multiplex HIV-1/2 Syphilis AB test

For the detection of antibodies to syphilis and HIV

DEVICE

Multiplo Rapid TP/HIV test

For the detection of antibodies to syphilis and HIV

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Alberta Health services

    collaborator OTHER

  • Canadian Foundation for AIDS Research (CANFAR)

    collaborator OTHER

  • University of Alberta

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2021-02-11
Completion
2022-02-14

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04514848 on ClinicalTrials.gov