HIV InfectionsNCT06463314
Multiplo Near Patient Non-HCP Study
A study testing Multiplo TP/HIV Antibody Test in people with HIV Infections and Syphilis Infection, run by Unity Health Toronto at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, 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
- 0 participants
- Where
- 4 sitesCanada
- Study dates
- 5 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Show all 9Show fewer
- 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
Who cannot join
- Participants considered ineligible for participation in the trial are those who meet any of the following 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Hassle Free Clinic
Toronto, Ontario, M5B 1G3
Women's Health in Women's Hands
Toronto, Ontario, M5B 1J3
Cool Aid Community Health Centre
Victoria, British Columbia, V8W 1M8
Nine Circles Community Health Centre
Winnipeg, Manitoba, R3G 0X2
About this study
Official title: A Prospective Cross-Sectional Study to Evaluate Performance and Usability of Multiplo® TP/HIV Test at Point-Of-Care Sites in the Hands of Untrained Non-Health Care Professional Operators
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.
Read the 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
- Being tested
- Multiplo TP/HIV Antibody Test
- Keywords
- point of care, health care provider, screen test, device trial
- 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 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. 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 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.
Measured: 6 months
Secondary outcomes (1)
Percent of correctly interpreted mock devices by untrained, non-healthcare professional operators
Non-health care professionals will be asked to read results from a variety of mock test results. These mock tests will be blind coded, provided to the non-HCP in random order followed by review and documentation of the panels of contrived test results to be interpreted by study Operators. The results indicated by the non-HCP will be compared against the code to determine the ability of the non-HCP to correctly interpret a variety of results including, strong positive, weak positive, invalid, weak negative and strong negative. will be given a panel of
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 posted17 Jun 2024
- Study start5 May 2025
- Primary completion5 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Why it stopped: The device manufacturer is no longer seeking licensure for this use-case in Canada.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- screening for HIV and syphilis infection at point of care settings by untrained non-professional health care providers
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463314
- Sponsor's protocol ID
- REACH Multiplo TP/HIV-01
- Status last verified
- Oct 2024
- First submitted
- 31 May 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31078660
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cross-Sectional Study to Evaluate Performance and Usability of Multiplo® TP/HIV Test at Point-Of-Care Sites in the Hands of Untrained Non-Health Care Professional Operators
- ClinicalTrials.gov ID
- NCT06463314
- Acronym / sponsor ID
- REACH Multiplo TP/HIV-01
- Conditions
- HIV Infections, Syphilis Infection
- Keywords
- point of care, health care provider, screen test, device trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The device manufacturer is no longer seeking licensure for this use-case in Canada.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 17 Jun 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, 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.
Study design
- Primary purpose
- Diagnosis
- 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 by untrained non-professional health care providers
| Arm | Type | Receives |
|---|---|---|
| participants with known and unknown HIV and/or syphilis status | Experimental | Device: Multiplo TP/HIV Antibody TestAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Participants considered ineligible for participation in the trial are those who meet any of the following 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
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 known and unknown HIV and/or syphilis status |
Primary outcome
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.
Time frame: 6 months
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.
1 secondary outcome
Percent of correctly interpreted mock devices by untrained, non-healthcare professional operators
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 31078660Harris 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Infections and Syphilis Infection, run by Unity Health Toronto at 4 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 4 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: withdrawn, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). 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 NCT06463314, which also lists 1 linked publication.
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 26 Jun 2025.