Multiplo Tp/HIV Self-Test

NCT06716450 | Recruiting

• 1 other identifier: REACH Multiplo ST-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-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 Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons / intended users can perform the Multiplo Tp/HIV Self-Test without any increased risk of obtaining erroneous results.

Conditions

HIV Infection; Syphilis Infection

Keywords

self-test; device trial; screen test

Outcome Measures

Primary Outcomes (2)

• Percent positive and negative agreement of the Multiplo® TP/HIV Self-Test 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 Self-Test 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

• Descriptive analysis of sociodemographic characteristics of people experiencing homelessness who are accessing HIV and Syphilis testing

  The embedded study aims to understand the sociodemographic and health profile of PEH accessing WHIWH. Descriptive analysis of sociodemographic variables, risk behaviours, HIV/syphilis testing variables will be completed.

  6 months

Secondary Outcomes (2)

• Percent of correctly interpreted mock devices by self-test participants.

  6 months

• Rates of Positive HIV and Syphilis and rates of first time testers among people experiencing homelessness

  6 months

Study Arms (1)

Participants with unknown HIV and syphilis status

EXPERIMENTAL

All participants will self-test fingerstick blood testing with the test device, 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 unknown HIV and 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 ≥18 years of age.
• Can speak/read/write English or French.
• Have presented for voluntary testing for HIV and/or syphilis infection in the clinic or community-based setting.
• Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results.
• Are willing to be a participant in the study.
• Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form.
• Can complete the required testing on the allocated testing day.
• Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods.
• Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior).

You may not qualify if:

• Are known HIV and/or syphilis positive.
• Have ever tested positive for syphilis or HIV at any time.
• Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease.
• Are familiar with the Multiplo® TP/HIV Self-Test.
• Are investigator site employees or immediate family members of sponsor or investigator sites.
• Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.
• Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests).
• Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see/read by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (3)

Cool Aid Community Health Centre

Victoria, British Columbia, V8W 1M8, Canada

RECRUITING

Hassle Free Clinic

Toronto, Ontario, M5B 1G3, Canada

RECRUITING

Women's Health in Women's Hands

Toronto, Ontario, M5B 1J3, Canada

RECRUITING

Related Publications (8)

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

  PMID: 10474547 BACKGROUND

• Allen CG, Barbero C, Shantharam S, Moeti R. Is Theory Guiding Our Work? A Scoping Review on the Use of Implementation Theories, Frameworks, and Models to Bring Community Health Workers into Health Care Settings. J Public Health Manag Pract. 2019 Nov/Dec;25(6):571-580. doi: 10.1097/PHH.0000000000000846.

  PMID: 30180116 BACKGROUND

• Israel BA, Schulz AJ, Parker EA, Becker AB. Critical Issues in Developing and Following Community-Based Participatory Research Principles. In: Minkler M, Wallerstein N, editors. Community-Based Participatory Research for Health. Jossey-Bass; 2008. p. 47-62.

  BACKGROUND

• Scott K, Beckham SW, Gross M, Pariyo G, Rao KD, Cometto G, Perry HB. What do we know about community-based health worker programs? A systematic review of existing reviews on community health workers. Hum Resour Health. 2018 Aug 16;16(1):39. doi: 10.1186/s12960-018-0304-x.

  PMID: 30115074 BACKGROUND

• Berg RC, Page S, Ogard-Repal A. The effectiveness of peer-support for people living with HIV: A systematic review and meta-analysis. PLoS One. 2021 Jun 17;16(6):e0252623. doi: 10.1371/journal.pone.0252623. eCollection 2021.

  PMID: 34138897 BACKGROUND

• Mwai GW, Mburu G, Torpey K, Frost P, Ford N, Seeley J. Role and outcomes of community health workers in HIV care in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2013 Sep 10;16(1):18586. doi: 10.7448/IAS.16.1.18586.

  PMID: 24029015 BACKGROUND

• Jackson C, Tremblay G. Accelerating our response: Government of Canada five-year action plan on sexually transmitted and blood-borne infections. Can Commun Dis Rep. 2019 Dec 5;45(12):323-326. doi: 10.14745/ccdr.v45i12a04. eCollection 2019 Dec 5.

  PMID: 32167085 BACKGROUND

• Canadian Institutes of Health Research. CIHR HIV/AIDS and STBBI research initiative strategic plan 2022-2027. Ottawa: Canadian Institutes of Health Research = Instituts de recherche en santé du Canada; 2022.

  BACKGROUND

Related Links

• The Street Health Report 2007 \| The Homeless Hub
• BC Public Advisory Network. What is Community-Based Research?
• Canadian Definition of Homelessness \| The Homeless Hub

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

Central Study Contacts

Megan Cedrone, BSc, MSc

CONTACT

647-786-8711; Megan.Cedrone@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Screening for HIV and syphilis infection at point of care settings as a self-test in the presence of a trained, silent observer. The embedded study will involve participants interacting with a peer navigator following the self-test to discuss prevention and care options for HIV and syphilis.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 4, 2024
• Study Start: June 12, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)