Multiplo Test for HIV and Syphilis

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

800 Participants Needed

Trial Summary

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

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 Test for HIV and Syphilis safe for humans?

The Multiplo Test for HIV and Syphilis is a rapid diagnostic tool used to detect antibodies for these infections. While the studies focus on its effectiveness, they do not report any safety concerns, suggesting it is generally safe for use in humans. ^{1 3 4 6 7}

How is the Multiplo TP/HIV Antibody Test different 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 quick, same-day testing and treatment, which is not typically possible with separate tests for each infection. ^{1 2 3 6 8}

What is the purpose of this trial?

To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) 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 Inc. (Halifax, NS, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood samples that is seeking approval from Health Canada for use by trained healthcare professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

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

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

Field evaluation of a dual rapid Human Immunodeficiency Virus and treponemal syphilis rapid test in community-based clinics in Los Angeles and New York. [2021]

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

Italian national survey of blood donors: external quality assessment (EQA) of syphilis testing. [2021]

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

Characterization of Treponema pallidum particle agglutination assay-negative sera following screening by treponemal total antibody enzyme immunoassays. [2021]