Multiplo Test for HIV and Syphilis

No longer recruiting at 3 trial locations

Overseen By Sean Rourke, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Site employees, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new point-of-care (POC) blood test called the Multiplo TP/HIV Antibody Test, which can quickly identify HIV and syphilis using a simple fingerstick. The researchers aim to determine if individuals without formal medical training can use this test accurately, potentially increasing detection of these infections in communities. The trial seeks participants regardless of their HIV or syphilis status, who are willing to have their blood tested. This opportunity may appeal to those interested in advancing testing methods for these diseases. As an unphased trial, it offers a unique chance to contribute to the development of accessible testing methods that could benefit communities worldwide.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing for HIV and syphilis, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this test is safe for use by untrained health care providers?

Research shows that the Multiplo TP/HIV Antibody Test quickly and accurately detects antibodies for both HIV and syphilis. This test is already in use in Europe, where it has received a CE mark, indicating it meets health and safety standards.

Although specific safety data for this test is unavailable, similar tests have been used without major safety concerns. The test requires a simple fingerstick blood sample, which most people tolerate well. Studies have not reported any safety issues or side effects.

This test helps reach more people who might not know they have HIV or syphilis by making testing faster and easier. Researchers are also studying whether non-professional health workers can use it safely and effectively, potentially expanding access to testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multiplo TP/HIV Antibody Test because it has the potential to simplify and speed up the diagnosis of HIV and syphilis. Unlike traditional methods that require professional healthcare providers and laboratory settings, this test can be administered by non-professionals using just a fingerstick blood sample. This approach makes testing more accessible, especially in remote or underserved areas, and could significantly enhance early detection and treatment opportunities for these conditions.

What evidence suggests that the Multiplo TP/HIV Antibody Test is effective for detecting HIV and syphilis?

Research has shown that the Multiplo TP/HIV Antibody Test, which participants in this trial will undergo, effectively detects HIV and syphilis. Studies have found that this test correctly identifies 99.0% to 99.6% of HIV cases and 98.3% to 99.0% of syphilis cases, meaning it can accurately detect almost all cases of these infections. The test is simple and quick to use, making it ideal for situations requiring fast results. Its ease of use and high accuracy make it effective for identifying individuals with HIV and syphilis. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals at least 16 years old who can read English or French, consent to the study, and provide a detailed medical history. Participants must be willing to give blood samples and undergo HIV and syphilis testing with the Multiplo TP/HIV Antibody Test. Those previously diagnosed with syphilis or with an unknown HIV/syphilis status (with last negative test over 3 months ago) may join.

Inclusion Criteria

I agree to be tested for HIV and syphilis.

My last HIV test was negative and done more than 3 months ago.

I can understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Testing

Participants undergo fingerstick blood testing with the Multiplo Test and venous blood testing at a central laboratory

1 day

1 visit (in-person)

Follow-up

Participants with unknown HIV and/or syphilis status return for follow-up to obtain laboratory test results

2 weeks

1 visit (in-person)

Operator Assessment

Untrained non-professional operators complete usability and interpretation assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Multiplo TP/HIV Antibody Test

Trial Overview The trial is evaluating whether non-professional health workers can accurately use a point-of-care test called Multiplo TP/HIV Antibody Test for detecting HIV and syphilis antibodies in fingerstick blood samples without increased risk of errors compared to trained healthcare professionals.

How Is the Trial Designed?

Group I: participants with known and unknown HIV and/or syphilis status Experimental Treatment 1 Intervention

All participants will undergo fingerstick blood testing with the test device administered by untrained non-professional health care providers, along with venous blood testing at a central laboratory using licensed gold standard comparator methods.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

The MedMira Multiplo Rapid TP/HIV Antibody Test demonstrated high sensitivity (93.8%) and perfect specificity (100%) for detecting HIV antibodies, indicating it is a reliable tool for HIV screening.

For syphilis detection, the test showed good sensitivity (81.0%) and perfect specificity (100%), suggesting it can effectively integrate syphilis screening into existing HIV prevention programs, potentially increasing overall testing rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field Evaluation of a Dual Rapid Immunodiagnostic Test for HIV and Syphilis Infection in Peru. Bristow, CC., Leon, SR., Huang, E., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06716450

Study Details | NCT06716450 | Multiplo Tp/HIV Self-Test The Multiplo® TP/HIV Test is intended as an aid in the diagnosis of HIV1/2 and Syphilis infections in patients with signs and symptoms of HIV and syphilis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6754342/

A systematic review and meta-analysis of studies ... Diagnostic accuracy studies evaluated the performance of the SD BIOLINE HIV/Syphilis Duo Test, the MedMira Multiplo Rapid TP/HIV Antibody Test ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0020729215002015

Laboratory evaluation of three dual rapid diagnostic tests ... All three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%–99.6% for HIV and 98.3%–99.0% for syphilis, and a ...

4. withpower.com withpower.com/trial/phase-syphilis-11-2024-90c84

Self-Test for HIV and Syphilis · Info for Participants The Multiplo TP/HIV Antibody Test is a rapid test used to detect antibodies for HIV and syphilis. While the studies focus on its effectiveness and ease of use, ...

5. journals.asm.org journals.asm.org/doi/10.1128/jcm.02468-14

Laboratory Evaluation of Three Rapid Diagnostic Tests for ... The performance of three research-use-only, dual HIV and syphilis rapid diagnostic tests (RDTs) was evaluated for 150 patient serum samples.

6. withpower.com withpower.com/trial/phase-infections-6-2024-69150

Multiplo Test for HIV and Syphilis · Info for Participants The Multiplo TP/HIV Antibody Test is a rapid test that can detect both HIV and syphilis antibodies, allowing for quick and integrated screening. This dual ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06716450?term=medmira&viewType=Table&checkSpell=&rank=5

Study Details | Multiplo Tp/HIV Self-Test Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK602665/

Rapid Syphilis Testing - NCBI Bookshelf - NIH The Medmira Multiplo TP/HIV test and the Medmira Multiplo complete syphilis (TP/nTP) antibody test tests have received a CE mark in Europe, but are not FDA ...

9. unityhealth.to unityhealth.to/2025/01/dual-hiv-syphilis-rapid-test/

St. Michael's research leads to Health Canada approval of ... “Our Multiplo® TP/HIV device is the fastest testing solution for HIV-1/2 and Syphilis and provides an immediate result which does not fade. The ...