Active not recruitingOBSERVATIONAL

Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis

This research study is looking at a new, fast test for syphilis, called the DPP® Syphilis Screen & Confirm Point-of-Care Test (POCT). This test uses a small finger-prick blood sample and gives quick results, right there in the clinic. Researchers want to find out if this rapid test is as accurate as the usual lab tests for syphilis. They also want to see if using this quick test can speed up how quickly people are diagnosed and treated. About 600 adults (aged 18 and over) who are already visiting a health centre in Winnipeg, Canada, for sexual health care will be asked to take part. Participants will provide a blood sample and share their experience with the new test.

At a glance

Status

Active not recruiting

Sponsor

University of Manitoba

Enrolment target

600

Start

05 Mar 2025

Estimated completion

31 Dec 2026

Syphilis

What is this study about?

This study is all about finding a better way to test for syphilis, a sexually transmitted infection. Syphilis can be treated, especially if caught early, but standard lab tests can sometimes take a while to give results. This waiting period can be stressful and might delay treatment.

The researchers are examining a new, quick test called the DPP® Syphilis Screen & Confirm. It's an "on-the-spot" or "point-of-care" test, meaning it can be done in the clinic and give results much faster than sending a sample to a lab. They want to see two main things: first, is this rapid test as reliable and accurate as the traditional lab tests? And second, can using this quick test help people get diagnosed and start treatment for syphilis more quickly?

To figure this out, around 600 adults attending a health centre will take part. Their results from the rapid test will be compared with the results from the usual lab tests. This will help the researchers understand if the new rapid test is a good option for quickly identifying syphilis. If successful, this new test could help more people get the treatment they need, faster.

Key takeaways

This study is testing a new, rapid syphilis test that uses a finger-prick blood sample.
The goal is to see if this quick test is accurate and can speed up diagnosis and treatment.
About 600 adults aged 18+ will take part during their routine sexual health checks.
Participation involves a finger-prick blood test and a short feedback survey.
You'll continue to receive your standard medical care; this study adds to it.
Your decision to join or leave the study will not affect your care.

Who may be eligible?

You might be able to join this study if you are 18 years old or older and are visiting the Nine Circles Community Health Centre in Winnipeg, Canada, for routine sexual health check-ups. You should be in need of a syphilis test as part of your usual care there. It's important that you can understand what the study involves and agree to take part.

Even if you've had other sexually transmitted infections in the past, or if the doctors think you might have another STI, you can still be part of this study as long as a syphilis test is part of your care.

However, you won't be able to join if you seem to be very unwell, confused, or intoxicated when the healthcare team assesses you. Also, if you are under 18, or if you've already taken part in this specific POCT study within the last 90 days and don't have any symptoms, you won't be eligible this time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you visiting the Nine Circles Community Health Centre for sexual health care?
Do you need a syphilis test as part of your care today?
Can you understand information about the study and agree to take part?
Have you NOT already taken part in this specific rapid test study within the last 90 days (if asymptomatic)?
Do you feel well enough to participate today (not severely unwell, confused, or intoxicated)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve a few simple steps during one of your regular visits to the clinic. First, you'll be asked to give a small blood sample. This will be an easy finger-prick, similar to how some people check their blood sugar. This sample will be used for the rapid syphilis test.

Afterwards, you'll be asked to fill out a short survey. This survey is important because it helps the researchers understand your experience with the rapid test. There are no extra clinic visits specifically for this study. The entire process, including the finger-prick and survey, will happen during your routine sexual health appointment. You will be one of about 600 participants in total, with the study running for about 12 months.

Potential risks and benefits

Taking part in this study means you'll contribute to important research that could lead to faster syphilis diagnosis for many people in the future. There are very few risks involved; the finger-prick for the blood sample might cause a tiny, brief sting or bruise, similar to what you'd expect from any blood test. There are no medical recommendations being made in this study, and you will continue to receive your usual medical care from the clinic. Remember, taking part is completely voluntary, and you are free to change your mind and withdraw from the study at any time without it affecting your care at the clinic.

Locations (1)

Nine Circles Community Health Centre
Verified postcode
Winnipeg, Canada

Common questions

What is a 'point-of-care test'?

It's a quick medical test that can be done right in the clinic or doctor's office, giving results very quickly without sending a sample to a lab.

Will this study affect my usual syphilis testing?

No, you will still receive standard syphilis testing. This study adds an extra rapid test to see if it works well alongside the usual methods.

Is the rapid test accurate?

That's exactly what the study is trying to find out! Researchers are comparing it to standard lab tests to check its accuracy.

What happens if I get a positive result from the rapid test?

Your healthcare provider will discuss your results with you and follow up with standard confirmed testing and treatment plans, just as they would with any syphilis diagnosis.

How long will my participation take?

Your participation will only take a short amount of extra time during one of your regular clinic visits – just enough time for a finger-prick and a short survey.