Rapid Testing for HIV and Syphilis

(AI Trial)

Not currently recruiting at 7 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: < 16 years, Intoxicated, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to enhance testing and treatment for HIV and syphilis in underserved communities across Alberta, Manitoba, and Saskatchewan. It employs rapid point-of-care tests, such as the INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test, and Multiplo Complete Syphilis (TP/nTP) Antibody Test, which provide quick results for these infections. Individuals who regularly visit community clinics for STI checks may be ideal candidates for this trial. The researchers plan to involve 10,000 participants over three years, facilitating connections to necessary care for those who test positive. As an unphased trial, this study offers a unique opportunity to contribute to improving healthcare access and outcomes in the community.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these rapid tests are safe for use in humans?

Studies have shown that the INSTI HIV-1/2 Antibody Test effectively detects HIV antibodies quickly and has FDA approval. It is widely used and considered safe. Research indicates that the INSTI Multiplex HIV-1/2 Syphilis Antibody Test is also approved in Canada and provides accurate results for both HIV and syphilis in just a few minutes. This test uses a simple fingerprick method, which is easy and safe for users.

The Multiplo Complete Syphilis Antibody Test has been used in research settings. Although specific safety data is not provided, similar rapid tests are generally considered safe. In clinical trials, these tests usually demonstrate good safety profiles, meaning they do not harm users. Overall, these rapid tests are designed to be safe and easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these rapid testing methods for HIV and syphilis because they offer quick and reliable results, potentially transforming STI diagnostics. Unlike traditional testing, which can take days for results, the INSTI and Multiplo tests deliver outcomes in just minutes, allowing for immediate patient care decisions. This rapid turnaround is crucial for timely treatment and reducing the spread of these infections. Additionally, these tests can be administered by both healthcare professionals and trained non-healthcare personnel, broadening access to testing in community settings. This flexibility and speed make these testing methods a promising advancement in managing HIV and syphilis.

What evidence suggests that these rapid tests are effective for detecting HIV and syphilis?

This trial will evaluate the effectiveness of rapid tests for HIV and syphilis. Studies have shown that the INSTI HIV-1/2 Antibody Test, which participants may receive, is highly effective, with 100% accuracy in identifying both HIV-positive and HIV-negative individuals. The INSTI Multiplex HIV-1/2 Syphilis Antibody Test, another option in this trial, effectively detects HIV and excels at identifying syphilis. The Multiplo Complete Syphilis (TP/nTP) Antibody Test, also tested in this trial, checks for both types of syphilis antibodies, making it a comprehensive tool for diagnosing syphilis. These tests are quick and reliable, providing immediate results for accurate diagnosis and treatment. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The Ayaangwaamiziwin Initiative is for individuals in underserved communities within the Canadian Prairie provinces who may be at risk of HIV/AIDS and syphilis. The trial aims to reach 10,000 people with rapid point-of-care testing.

Inclusion Criteria

I am over 16 and getting STBBI tests at certain places.

Able to provide informed consent

Are able to read/understand English or French

Exclusion Criteria

Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study

Are regulated healthcare professionals including nurses, nurse practitioners, physicians, dentists, pharmacists, and laboratory technologists

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing and Treatment

Participants receive rapid point-of-care testing for HIV and syphilis and immediate treatment for syphilis if necessary

3 years

Multiple visits as needed for testing and treatment

Linkage to Care

Participants are connected to culturally appropriate care and treatment for syphilis and HIV

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• INSTI HIV-1/2 Antibody Test
• INSTI Multiplex HIV-1/2 Syphilis Antibody Test
• Multiplo Complete Syphilis (TP/nTP) Antibody Test

Trial Overview

This trial tests a 'test, treat, and connect' approach using rapid POC tests: INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test, and Multiplo Complete Syphilis (TP/nTP) Antibody Test.

How Is the Trial Designed?

Group I: Patients Experimental Treatment 3 Interventions

Patients will be anyone presenting at the community site clinics for regular STI testing

Group II: Healthcare Professionals Active Control 1 Intervention

Healthcare professionals (e.g., nurses) that will conduct patient intake, consent patients, provide POC testing (test operators), and provide treatment and linkage to care where necessary.

Group III: Non-Healthcare Professionals Active Control 1 Intervention

Non-Healthcare Professionals (e.g., health navigators that are peers with lived experiences) that will conduct community outreach, and for sites that are doing non-healthcare professional testing, the health navigators will conduct patient intake, consent patients, provide POC testing (test operators), and link patients to treatment where necessary.

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]

The INSTI HIV-1/HIV-2 Rapid Antibody test demonstrated high sensitivity (99.84% for HIV-1 and 100% for HIV-2) and specificity (99.80%) when tested with plasma specimens, making it a reliable option for detecting HIV antibodies.

INSTI was able to detect HIV infections significantly earlier than other FDA-approved rapid tests, identifying reactivity 9 days before a positive Western blot result, which is crucial for timely diagnosis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance evaluation of the point-of-care INSTI™ HIV-1/2 antibody test in early and established HIV infections. Adams, S., Luo, W., Wesolowski, L., et al.[2019]

The INSTI™ HIV-1/HIV-2 antibody test is a rapid point-of-care test that provides results in under 5 minutes and is easy to use, making it a valuable tool for HIV prevention and control programs globally.

While the INSTI™ test shows comparable performance to other rapid tests, it detects HIV seroconversion later than standard laboratory assays, indicating it may not be the first choice for early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The INSTI HIV-1/HIV-2 antibody test: a review. Singh, AE., Lee, B., Fenton, J., et al.[2013]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6522311/

Field Performance of the INSTI HIV-1/-2 Antibody Test in ...

INSTI test yielded the same results as other rapid tests in all participants, thus showing a 100% sensitivity (95% CI: 93.2 – 100.0%) and specificity (95% CI: ...

2.

stacks.cdc.gov

stacks.cdc.gov/view/cdc/157959/cdc_157959_DS1.pdf

Performance evaluation of the point-of-care INSTI™ HIV-1/ ...

Considering the observed test performance and the almost immediate results, INSTI is an accurate option to detect HIV-1/HIV-2 antibodies in ...

3.

aidsmap.com

aidsmap.com/about-hiv/how-accurate-are-rapid-point-care-tests-hiv

How accurate are rapid, point-of-care tests for HIV?

The accuracy of different rapid tests ; Uni-Gold HIV (Trinity). IgG + IgM. 99.8% ; INSTI HIV-1/HIV-2 Antibody Test (bioLytical). IgG + IgM. 100%.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1386653217300896

Performance evaluation of the point-of-care INSTI™ HIV-1 ...

INSTI was accurate at detecting HIV-1 and HIV-2 antibodies. · INSTI detected more early HIV-1 infections than antibody-based lateral flow tests. · In whole blood, ...

5.

insti.com

insti.com/wp-content/uploads/2020/11/65-1011D-INSTI-HIV-Core-Visual-Aid-US-Web.pdf?srsltid=AfmBOorLpOOWR-593LnXoOV1ppxfsjAkf8e2-vLmCL9mxuX-3S1agmxM

HIV-1/HIV-2 Antibody Test - INSTI

INSTI was shown to have over 99.8% sensitivity and 99.5% specificity. Sensitivity of a test is defined as the percentage of results that will be positive when ...

6.

fda.gov

fda.gov/media/189319/download?attachment

INSTI® HIV Self Test Device

In this study, the INSTI HIV-1 Antibody Test demonstrated the capability of detecting low levels of antibodies to HIV-1 equivalent to FDA ...

7.

hivtestingontario.ca

hivtestingontario.ca/wp-content/uploads/2021/08/SDS-001-INSTI-HIV-1-HIV-2-Antibody-Test-Kit_EN_Rev5.pdf

SDS-001 INSTI® HIV-1 / HIV-2 Antibody Test Kit

Under GHS, the cut-off level for reproductive toxicity, carcinogenicity and category 1 mutagenicity is ≥ 0.1%. The cut-off level for all other ...

8.

insti.com

insti.com/wp-content/uploads/2021/10/51-1008-L-INSTI-HIV1_HIV2-IFU-ROW-English.pdf?srsltid=AfmBOooe-XuueVeBVY9pJ4-aX73qrhA8QlYDRPYuTa8gm_vwmdabaUGP

HIV-1/HIV-2 Antibody Test - INSTI

Rapid HIV testing provides results during the initial visit allowing for ... “Summary of Safety and Effectiveness Data, 50-1110.” bioLytical ...

9.

fda.gov

fda.gov/media/79719/download

BP090032 Package Insert

The INSTI™ HIV-1/HIV-2 Antibody Test is a manual, visually read, flow-through immunoassay for the qualitative detection of HIV-1/HIV-2 ...

10.

ncbi.nlm.nih.gov

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

Rapid HIV Self-Testing - NCBI Bookshelf - NIH

If the INSTI HIV-1/2 Antibody Self Test is positive, the tester probably has HIV, but this result must be confirmed with a laboratory-based test ...