Multiplo Near Patient Non-HCP Study

NCT ID: NCT06463314

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-09-30

Brief Summary

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.

Detailed Description

This is a blinded, controlled study to evaluate the ability of the Operators, including peer testers, to perform and interpret the HIV and Syphilis results of the Multiplo TP/HIV Test. The non-registered health care professionals including peer testers are defined as non-health care professional (ie. Peers) paid site personnel that have no training or hands-on experience with the Multiplo Test. This protocol involves collection of fingerstick whole blood from a minimum of 800 Participants to test with the Multiplo Test. Testing will be conducted by the study Operators in near-patient clinical settings. Results from the Multiplo Test will be compared to results from blood based serological assays, including licensed 4th generation HIV EIA and syphilis EIA/RPR assays. Study Operator qualifications and assessment of the ease of device use will be evaluated. Operators will also read and interpret various contrived devices in order to assess their ability to correctly interpret a variety of potential test results.

All enrolled Participants will voluntarily provide medical history and the specimens according to Section 4, Study Procedures at Visit 1 (Day 1), for the testing with the Multiplo Test.

All Participants will have a laboratory test done for performance comparison, but only those with unknown HIV and/or syphilis status will be instructed to return to the clinic for a follow-up visit (Visit 2), two (2) weeks later to obtain their laboratory test results. Participants may also have a separate Point-of-Care (POC) test for HIV and/or syphilis conducted on site as part of the clinic's standard of care testing, outside of the protocol.

Activities in the plan of the study include:

• Selection of study Operators with informed consent for participation in the study
• Completion of Untrained Operator Eligibility and Assessment Questionnaire - prior to study start
• Screening of participants and obtaining informed consent
• Review of inclusion/exclusion criteria and completion of Participant Enrollment Questionnaire
• Specimen Collection and Testing:

• Collection of venous blood for Clinical Laboratory testing for HIV and Syphilis
• Collection of fingerstick whole blood for testing with the Multiplo Test
• Laboratory testing for HIV and Syphilis
• Clinical follow up for Participants with positive HIV and/or Syphilis test results from Clinical Laboratory testing
• Participants who test negative will have opportunities for preventative services including PrEP
• Completion of Untrained Operator Usability and Interpretation Questionnaire - after study completion
• Untrained non-professional Operator Mock Device Interpretation Assessment Following recruitment of participants and obtaining informed consent, Participants may be enrolled in the trial.

Conditions

HIV Infections; Syphilis Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

participants with known and unknown HIV and/or syphilis status

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.

Group Type: EXPERIMENTAL

Multiplo TP/HIV Antibody Test

Intervention Type: DEVICE

The Multiplo TP/HIV Antibody Test (MedMira Laboratories Inc., Halifax, NS), \["Multiplo TP/HIV Test"\] is a single use, rapid, vertical-flow in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus (HIV) Type 1/Type 2 and Treponema pallidum (Syphilis) in human fingerstick blood. 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 test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than five minutes. The Multiplo TP/HIV Test has not yet sought approval for self-testing. All required pre and post-test counselling guidelines must be followed in each setting in which the Multiplo TP/HIV Test is used. Results are read visually.

Interventions

Multiplo TP/HIV Antibody Test

The Multiplo TP/HIV Antibody Test (MedMira Laboratories Inc., Halifax, NS), \["Multiplo TP/HIV Test"\] is a single use, rapid, vertical-flow in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus (HIV) Type 1/Type 2 and Treponema pallidum (Syphilis) in human fingerstick blood. 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 test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than five minutes. The Multiplo TP/HIV Test has not yet sought approval for self-testing. All required pre and post-test counselling guidelines must be followed in each setting in which the Multiplo TP/HIV Test is used. Results are read visually.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Participants considered eligible for inclusion are those who:

• Are at least 18 years of age
• Are able to read/understand English or French
• Are able to provide informed consent
• Agree to provide accurate medical history
• Are able to provide up to 20mL blood by venipuncture, and a small amount of blood by fingerstick
• Agree to undergo testing for HIV and syphilis with the Multiplo® TP/HIV Test
• For the Participants previously diagnosed with HIV and/or syphilis, diagnosis can have occurred at any time prior to enrolment
• For the Participants with negative or unknown HIV and/or syphilis status - last HIV negative test must be greater than 3 months prior to date of consent

Exclusion Criteria

• Are site employees
• Are in the judgment of the investigator to be unable to complete the study or are unlikely to comply with the study protocol
• Have been previously enrolled in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cool Aid Community Health Centre

Victoria, British Columbia, Canada

Nine Circles Community Health Centre

Winnipeg, Manitoba, Canada

Hassle Free Clinic

Toronto, Ontario, Canada

Women's Health in Women's Hands

Toronto, Ontario, Canada

Countries

Canada

References

Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

Reference Type: BACKGROUND

PMID: 31078660 (View on PubMed)

Other Identifiers

REACH Multiplo TP/HIV-01

Identifier Type: -

Identifier Source: org_study_id