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Virus Therapy

Self-Test for HIV and Syphilis

N/A

Waitlist Available

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

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

Must have

Can speak/read/write English or French

Are ≥18 years of age

Must not have

Have ever tested positive for syphilis or HIV at any time

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a self-test for HIV and Syphilis in Canada to help identify more infected individuals. The test is easy to use and provides rapid results. The study aims to show that un

Who is the study for?

This trial is for individuals in Canada who may have HIV/AIDS or syphilis and are interested in a self-testing method. The study aims to include people who can follow simplified instructions to use the Multiplo Tp/HIV Self-Test on their own.

What is being tested?

The trial is testing the Multiplo Tp/HIV Self-Test, designed for personal use by untrained laypersons. It's meant to quickly identify HIV and syphilis antibodies from a fingerstick blood sample, with results available while still with a healthcare provider.

What are the potential side effects?

Since this intervention involves only using a self-test kit for detecting HIV and syphilis, there are no direct side effects like those seen with medications. However, incorrect usage could potentially lead to inaccurate test results.

Eligibility Criteria

Inclusion Criteria

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

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I can speak, read, and write in English or French.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for syphilis or HIV in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Descriptive analysis of sociodemographic characteristics of people experiencing homelessness who are accessing HIV and Syphilis testing

Percent positive and negative agreement of the Multiplo® TP/HIV Self-Test to the Participant's HIV and/or syphilis status confirmed by the lab results.

Secondary study objectives

Percent of correctly interpreted mock devices by self-test participants.

Rates of Positive HIV and Syphilis and rates of first time testers among people experiencing homelessness

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: Participants with unknown HIV and syphilis statusExperimental Treatment1 Intervention

All participants will self-test fingerstick blood testing with the test device, along with venous blood testing at a central laboratory using licensed gold standard comparator methods.

0 / 3Eligibility criteria met