Multiplo Near Patient Non-HCP Study

NCT06463314 | Withdrawn

• 1 other identifier: REACH Multiplo TP/HIV-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections; Syphilis Infection

Keywords

point of care; health care provider; screen test; device trial

Outcome Measures

Primary Outcomes (1)

• Percent positive and negative agreement of the Multiplo® TP/HIV Test performed by non-healthcare providers to the Participant's HIV and/or syphilis status confirmed by the lab results.

  The primary outcome for the study will be the percent positive and negative agreement of the Multiplo® TP/HIV Test performed by intended, untrained users to the Participant's HIV and/or syphilis status confirmed by the lab results. The percentages for positive and negative agreement will be calculated with the two-sided 95% confidence intervals for both as follows: % Positive Agreement= ((n) HIV or syphilis Multiplo reactive results )/((n) HIV or syphilis positive status)×100 % Negative Agreement= ((n)HIV or syphilis Multiplo non reactive results )/((n) HIV or syphilis negative status)×100 Percent positive and negative agreement will be calculated for each analyte (HIV or syphilis) separately.

  6 months

Secondary Outcomes (1)

• Percent of correctly interpreted mock devices by untrained, non-healthcare professional operators

  6 months

Study Arms (1)

participants with known and unknown HIV and/or syphilis status

EXPERIMENTAL

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.

Device: Multiplo TP/HIV Antibody Test

Interventions

Multiplo TP/HIV Antibody Test 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.

participants with known and unknown HIV and/or syphilis status

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (4)

Cool Aid Community Health Centre

Victoria, British Columbia, V8W 1M8, Canada

Location

Nine Circles Community Health Centre

Winnipeg, Manitoba, R3G 0X2, Canada

Location

Hassle Free Clinic

Toronto, Ontario, M5B 1G3, Canada

Location

Women's Health in Women's Hands

Toronto, Ontario, M5B 1J3, Canada

Location

Related Publications (1)

• 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.

  PMID: 31078660 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: blinded study design involving participants with known and unknown syphilis and HIV status where test providers are blinded to the participant status.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: screening for HIV and syphilis infection at point of care settings by untrained non-professional health care providers

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 17, 2024
• Study Start: May 5, 2025
• Primary Completion: September 5, 2025
• Study Completion: September 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)