Self-Test for HIV and Syphilis

Not yet recruiting at 3 trial locations

Overseen By Megan Cedrone, BSc, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: HIV positive, Syphilis positive, Healthcare professional, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new self-test kit, the Multiplo TP/HIV Antibody Test, which can quickly detect HIV and syphilis using a small fingerstick blood sample. Designed for simplicity, it allows individuals without medical training to use it and obtain immediate results. The goal is to help those unaware of their HIV or syphilis status to discover it and seek necessary assistance. Suitable participants have not previously tested positive for HIV or syphilis and are uncertain of their current status. As an unphased trial, this study offers participants the chance to contribute to important research that could simplify and improve access to testing for many.

Will I have to stop taking my current medications?

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 unlikely that your medications would be affected, but you should confirm with the trial organizers.

What prior data suggests that this self-test is safe for use by untrained individuals?

Research has shown that the Multiplo TP/HIV self-test is safe and accurate for detecting HIV and syphilis antibodies. Studies found that this test correctly identifies HIV in 93.8% of people who have it, demonstrating its sensitivity. It also has a perfect specificity of 100%, meaning it always correctly identifies those who do not have the disease.

The test is easy to use with a small blood sample from a fingerstick. Health Canada has reviewed it and is in the final stages of approving it for professional use, indicating it meets certain safety standards. The current study examines how well people can use the test independently without errors.

Overall, the Multiplo TP/HIV test is well-tolerated, with no reports of negative effects or safety issues from using the test itself. This makes it a reliable option for detecting HIV and syphilis at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multiplo TP/HIV Antibody Test because it offers a convenient and accessible way for people to test for HIV and syphilis simultaneously using a simple fingerstick blood test. Unlike traditional testing, which often requires separate visits to a clinic and waiting for lab results, this self-test provides quick and private results that could empower individuals to take control of their health. This method could significantly increase testing rates, especially in communities with limited access to healthcare facilities, ultimately helping in early detection and treatment of these infections.

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, used by participants in this trial, effectively detects HIV and syphilis. Studies have found that the test has a high sensitivity of 93.8% for HIV, correctly identifying the virus in most cases. It also achieves perfect specificity of 100%, accurately identifying individuals without the virus. For syphilis, the test accurately detects antibodies for Treponema pallidum, the bacteria causing syphilis. These findings indicate that the test reliably identifies both infections, making it a strong tool for quickly diagnosing HIV and syphilis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Are willing to be a participant in the study

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

I can understand and sign the consent form myself, or instruct someone to do it for me.

Exclusion Criteria

Do not meet the inclusion criteria

Are known HIV and/or syphilis positive

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Self-Test and Observation

Participants perform the Multiplo TP/HIV Self-Test and are observed by a trained observer. Participants interpret mock results and complete a questionnaire.

1 day

1 visit (in-person)

Laboratory Testing and Follow-up

Venous blood samples are collected for laboratory testing. Participants return for follow-up to receive laboratory results.

2 weeks

2 visits (in-person)

Data Analysis and Reporting

Analysis of sociodemographic characteristics and interpretation accuracy of self-test results.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Multiplo TP/HIV Antibody Test

Trial Overview 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.

How Is the Trial Designed?

Group I: Participants with unknown HIV and syphilis status Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

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]

The Architect Syphilis TP (AST) test demonstrated a significantly higher positive rate compared to the RPR test in preoperative and other disease groups, indicating its potential as a more effective screening tool for syphilis.

The AST showed high concordance rates of 97.4% with RPR and 97.5% with TPHA, suggesting it is a reliable method for detecting syphilis, including latent infections, when used in a new testing algorithm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of automated architect syphilis TP as a diagnostic laboratory screening test for syphilis]. Kim, J., Kim, WH., Cho, C., et al.[2019]

Citations

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

Study Details | NCT06716450 | Multiplo Tp/HIV Self-Test The primary outcome for the study will be the percent positive and negative agreement of the Multiplo® TP/HIV Self-Test to the Participant's HIV and/or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4675040/

Field Evaluation of a Dual Rapid Immunodiagnostic Test ... Our study showed excellent performance of the HIV antibody component of the test and very good performance for the Treponema pallidum antibody component of the ...

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

Study Details | Multiplo Tp/HIV Self-Test A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

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

Self-Test for HIV and Syphilis · Info for Participants The MedMira Multiplo Rapid TP/HIV Antibody Test demonstrated high sensitivity (93.8%) and perfect specificity (100%) for detecting HIV antibodies, indicating it ...

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

Laboratory evaluation of three dual rapid diagnostic tests ... Results. 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% ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595333/

Rapid HIV Self-Testing - NCBI Bookshelf - NIH In 50% of people, the test can detect HIV infection about 22 days after exposure, and in 99% of people can detect HIV infection 12 weeks (3 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06463314?term=AREA%5BBasicSearch%5D(medmira)&rank=6

NCT06463314 | Multiplo Near Patient Non-HCP Study 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. The ...

8. medmira.com medmira.com/wp-content/uploads/2020/01/CESIPYZIS0001EN-Multiplo-Rapid-TP-HIV-Test-Package-Insert-English.pdf

Mulplo Rapid TP/HIV Test - MedMira The test cartridge contains an immunoreactive test membrane comprised of specially formulated synthetic peptides to gp36, gp41, gp120, HIV‐1 group O, and TP.