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Point of Care Tests for Syphilis and HIV (PoSH Trial)

N/A

Waitlist Available

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Individuals who would routinely be screened for syphilis and HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate two quick tests that can detect both syphilis and HIV using a small blood sample from a finger prick. The study targets high-risk groups aged 16 and older, including those with limited access to healthcare services. These tests work by looking for specific proteins in the blood that indicate an infection with syphilis or HIV.

Eligible Conditions

Syphilis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Number returning for standard test results

Time to return for standard test results

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Individuals accessing screening for syphilis and HIVExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INSTI Multiplex HIV-1/2 Syphilis AB test

2020

N/A

~1530

Multiplo Rapid TP/HIV test

2020

N/A

~1530