Self-Test for HIV and Syphilis

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

900 Participants Needed

Trial Summary

What is the purpose of this trial?

To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons / intended users can perform the Multiplo Tp/HIV Self-Test without any increased risk of obtaining erroneous results.

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 data supports the effectiveness of the Multiplo TP/HIV Antibody Test treatment for HIV and syphilis?

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 testing approach can increase the number of people tested and enable same-day treatment, which is beneficial for managing these infections. ^{1 2 3 4 5}

Is the Multiplo TP/HIV Antibody Test safe for humans?

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, they do not report any specific safety concerns, suggesting it is generally safe for human use. ^{2 3 6 7 8}

How does the Multiplo TP/HIV Antibody Test differ from other treatments for HIV and syphilis?

The Multiplo TP/HIV Antibody Test is unique because it is a rapid point-of-care test that can simultaneously detect antibodies for both HIV and syphilis using a single specimen, allowing for integrated screening and potentially same-day testing and treatment, which is not typically possible with separate tests. ^{3 5 6 9 10}

Eligibility Criteria

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

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

Are willing to be a participant in the study

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of the SD Bioline HIV/Syphilis Duo assay at a rural health center in Southwestern Uganda. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Evaluating the effectiveness of HIV/syphilis joint self-testing in promoting syphilis testing among men who have sex with men]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Field Evaluation of a Dual Rapid Immunodiagnostic Test for HIV and Syphilis Infection in Peru. [2018]

4. England pubmed.ncbi.nlm.nih.gov

An evaluation of the SD Bioline HIV/syphilis duo test. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Utility of antitreponemal IgM testing in the diagnosis of early and repeat syphilis among HIV-infected and non-infected patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Determine Rapid Syphilis TP assay using sera. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

[Evaluation of automated architect syphilis TP as a diagnostic laboratory screening test for syphilis]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Syphilis serology in blood donors: a possible surrogate marker for human immunodeficiency virus risk. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Treponema pallidum immune adherence test for serodiagnosis of syphilis. 1: An improved method of the TPIA test. [2019]

10. Cuba pubmed.ncbi.nlm.nih.gov

[Serological diagnosis of syphilis in Cuban HIV/AIDS patients]. [2009]