Rapid Testing for HIV and Syphilis

(AI Trial)

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

10000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test, and Multiplo Complete Syphilis (TP/nTP) Antibody Test?

Research shows that the INSTI Multiplex test effectively detects HIV and syphilis antibodies with high sensitivity and specificity, meaning it accurately identifies those with and without the infections. This dual testing approach can increase the number of people tested and allow for quick, same-day results and treatment. ^{1 2 3 4 5}

Is the rapid test for HIV and syphilis safe for humans?

The rapid tests for HIV and syphilis, such as the INSTI HIV-1/2 Antibody Test and the INSTI Multiplex HIV-1/2 Syphilis Antibody Test, are widely used and approved for detecting these infections. They are generally considered safe for humans as they involve testing blood samples without introducing any substances into the body. ^{1 3 4 6 7}

How is the INSTI HIV-1/2 Antibody Test and INSTI Multiplex HIV-1/2 Syphilis Antibody Test different from other treatments for HIV and syphilis?

The INSTI HIV-1/2 Antibody Test and INSTI Multiplex HIV-1/2 Syphilis Antibody Test are unique because they provide rapid results for both HIV and syphilis testing, allowing for quicker diagnosis and treatment compared to traditional methods that may take longer to deliver results. ^{8 9 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities.

Eligibility Criteria

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

I am older than 18 years.

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Performance evaluation of the point-of-care INSTI™ HIV-1/2 antibody test in early and established HIV infections. [2019]

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

Laboratory Evaluation of a Point-of-Care Downward-Flow Assay for Simultaneous Detection of Antibodies to Treponema pallidum and Human Immunodeficiency Virus. [2022]

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

Laboratory evaluation of a dual rapid immunodiagnostic test for HIV and syphilis infection. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The INSTI HIV-1/HIV-2 antibody test: a review. [2013]

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

A simple diagnostic test using GH-releasing peptide-2 in adult GH deficiency. [2022]

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

Combined testing of anterior pituitary gland with insulin, thyrotropin-releasing hormone, and luteinizing hormone-releasing hormone. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Diagnosis of growth hormone deficiency in adults by testing with GHRP-6 alone or in combination with GHRH: comparison with the insulin tolerance test. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Lack of sensitivity of the 1-μg low-dose ACTH stimulation test in a paediatric population with suboptimal cortisol responses to insulin-induced hypoglycaemia. [2013]

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

Comparison of pituitary-adrenal responsiveness between insulin tolerance test and growth hormone-releasing peptide-2 test: a pilot study. [2022]