HIV InfectionNCT06716450
Multiplo Tp/HIV Self-Test
A study testing Multiplo TP/HIV Antibody Test in people with HIV Infection and Syphilis Infection, run by Unity Health Toronto at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Syphilis Infection
- What is being tested?
- Multiplo TP/HIV Antibody Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Jun 2025to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- Do not meet the inclusion criteria.
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Hassle Free Clinic
Toronto, Ontario, M5B 1G3
Francois MacDonald Research Coordinator, 416-922-0566, francois@hasslefreeclinic.org
- Recruiting
Women's Health in Women's Hands
Toronto, Ontario, M5B 1J3
Wangari Tharao, 416-263-4870, wangari@whiwh.com
Nonty Nkala, nonty@whiwh.com
- Recruiting
Cool Aid Community Health Centre
Victoria, British Columbia, V8W 1M8
Marion Selfridge, 250-385-1466, mselfridge@coolaid.org
Katie Besko, mselfridge@coolaid.org
About this study
Official title: A Study to Evaluate the Accuracy, Usability and Readability of the Multiplo® TP/HIV Antibody Self-Test Performed by Observed Intended Users in Canada and the Impact of Peer-led HIV and Syphilis Care Among People Experiencing Homelessness in Toronto
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.
Read the detailed description
This is a cross-sectional study that employs both observational and interview-based methods. All participants will read the instructions for use (IFU) and conduct the Multiplo TP/HIV Self-Test. They will not be provided any training prior to use. A trained Observer will observe and document the use of the test and independently read the lay user self-test result. 400 participants will also be provided with ten (10) mock devices with different results and asked to interpret those results (i.e. strong positive, weak positive, negative, invalid with no control line and no test dots, and invalid with no control line and positive test dots). The participants will then complete a questionnaire to share their opinions on usability and label comprehension of this test.
All participants will also have a venous blood sample collected for testing of serum at a central laboratory with a 4th generation HIV EIA and standard syphilis serology that will serve as the Comparator Methods (CM). All self-tests will be confirmed using laboratory-standard HIV and syphilis testing algorithms. The sensitivity and specificity of the self-test results will be calculated relative to the "clinical truth" of the participants' HIV and syphilis status determined by the comparator methods.
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 TP/HIV Self-Test. Persons with reactive syphilis self-tests may be counselled for immediate treatment.
All Participants will have a laboratory test done for performance comparison and 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.
- Subject recruitment
- Registration and confirmation of eligibility (enrolment questionnaire)
- Administering informed consent
- Review of inclusion/exclusion criteria and enrollment
- Venous blood specimen collection for laboratory testing
- Participant brought to a private room with site observer
- Observer instructs participant on study process (not testing procedure)
- Participant given one Multiplo Tp/HIV Self-Test package
- Participant performs the self-test and interprets the results
- Observer then interprets the participant's self test results
- Observer interviews participant with self-test questionnaire
- Participant given the option of participating in the Mock Result Interpretation exercise
- Participant returns to the site for the laboratory results in approximately 2 weeks
MOCK RESULTS INTERPRETATION A minimum of 400 participants across all study sites will complete device interpretation of contrived (mock) results from prepared devices. Devices will include contrived reactive, weakly reactive, negative, and 2 types of invalid results with their reactivity blinded to the participant.
- Conditions
- HIV Infection, Syphilis Infection
- Being tested
- Multiplo TP/HIV Antibody Test
- Keywords
- self-test, device trial, screen test
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplo TP/HIV Antibody TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Multiplo TP/HIV Antibody Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
Percent of correctly interpreted mock devices by self-test participants.
Participants will answer a series of questions after they complete the Multiplo® TP/HIV Self-Test assessment and Interpretation of Results - Mock Devices. Participants will be given a panel of contrived devices and asked to interpret the results of the contrived devices. Participant answers will be compared to known results from the assigned panels.
Measured: 6 months
Rates of Positive HIV and Syphilis and rates of first time testers among people experiencing homelessness
Number of PEH who have tested positive for HIV and/or syphilis in the laboratory test. Number of PEH tested for HIV and/or syphilis for the first time through the project. Number of PEH who have been tested for HIV and/or syphilis before the intervention and which type of service.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start12 Jun 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716450
- Sponsor's protocol ID
- REACH Multiplo ST-01
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10474547Allen 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.
PubMed 30180116Israel 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.
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.
PubMed 30115074Berg 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.
PubMed 34138897Mwai 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.
PubMed 24029015Jackson 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.
PubMed 32167085Canadian 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Accuracy, Usability and Readability of the Multiplo® TP/HIV Antibody Self-Test Performed by Observed Intended Users in Canada and the Impact of Peer-led HIV and Syphilis Care Among People Experiencing Homelessness in Toronto
- ClinicalTrials.gov ID
- NCT06716450
- Acronym / sponsor ID
- REACH Multiplo ST-01
- Conditions
- HIV Infection, Syphilis Infection
- Keywords
- self-test, device trial, screen test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cross-sectional study that employs both observational and interview-based methods. All participants will read the instructions for use (IFU) and conduct the Multiplo TP/HIV Self-Test. They will not be provided any training prior to use. A trained Observer will observe and document the use of the test and independently read the lay user self-test result. 400 participants will also be provided with ten (10) mock devices with different results and asked to interpret those results (i.e. strong positive, weak positive, negative, invalid with no control line and no test dots, and invalid with no control line and positive test dots). The participants will then complete a questionnaire to share their opinions on usability and label comprehension of this test.
All participants will also have a venous blood sample collected for testing of serum at a central laboratory with a 4th generation HIV EIA and standard syphilis serology that will serve as the Comparator Methods (CM). All self-tests will be confirmed using laboratory-standard HIV and syphilis testing algorithms. The sensitivity and specificity of the self-test results will be calculated relative to the "clinical truth" of the participants' HIV and syphilis status determined by the comparator methods.
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 TP/HIV Self-Test. Persons with reactive syphilis self-tests may be counselled for immediate treatment.
All Participants will have a laboratory test done for performance comparison and 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.
- Subject recruitment
- Registration and confirmation of eligibility (enrolment questionnaire)
- Administering informed consent
- Review of inclusion/exclusion criteria and enrollment
- Venous blood specimen collection for laboratory testing
- Participant brought to a private room with site observer
- Observer instructs participant on study process (not testing procedure)
- Participant given one Multiplo Tp/HIV Self-Test package
- Participant performs the self-test and interprets the results
- Observer then interprets the participant's self test results
- Observer interviews participant with self-test questionnaire
- Participant given the option of participating in the Mock Result Interpretation exercise
- Participant returns to the site for the laboratory results in approximately 2 weeks
MOCK RESULTS INTERPRETATION A minimum of 400 participants across all study sites will complete device interpretation of contrived (mock) results from prepared devices. Devices will include contrived reactive, weakly reactive, negative, and 2 types of invalid results with their reactivity blinded to the participant.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants with unknown HIV and syphilis status | Experimental | Device: Multiplo TP/HIV Antibody TestAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- Do not meet the inclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplo TP/HIV Antibody TestThe 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. | Device | Participants with unknown HIV and syphilis status |
Primary outcome
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.
Time frame: 6 months
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.
Descriptive analysis of sociodemographic characteristics of people experiencing homelessness who are accessing HIV and Syphilis testing
Time frame: 6 months
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.
2 secondary outcomes
Percent of correctly interpreted mock devices by self-test participants.
Time frame: 6 months
Rates of Positive HIV and Syphilis and rates of first time testers among people experiencing homelessness
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 10474547Glasgow 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.
- Background: PubMed 30180116Allen 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.
- BackgroundIsrael 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: PubMed 30115074Scott 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.
- Background: PubMed 34138897Berg 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.
- Background: PubMed 24029015Mwai 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.
- Background: PubMed 32167085Jackson 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.
- BackgroundCanadian 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.
- The Street Health Report 2007 \| The Homeless HubLink provided by the sponsor.
- BC Public Advisory Network. What is Community-Based Research?Link provided by the sponsor.
- Canadian Definition of Homelessness \| The Homeless HubLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiplo TP/HIV Antibody Test in people with HIV Infection and Syphilis Infection, run by Unity Health Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Cedrone, BSc, MSc (647-786-8711, Megan.Cedrone@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06716450, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.