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Point-of-Care TestingAINCT06893159

Ayaangwaamiziwin Initiative: Carefulness and Preparedness

A study testing INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test and Multiplo Complete Syphilis (TP/nTP) Antibody Test in people with Point-of-Care Testing and HIV, run by Unity Health Toronto at 8 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Point-of-Care Testing, HIV, Syphilis
What is being tested?
INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test and Multiplo Complete Syphilis (TP/nTP) Antibody Test
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,000 participants
Where
8 sitesCanada
Study dates
1 Feb 2025to Mar 2028
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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Individuals > 16 years old accessing STBBI testing at specific locations
  • Able to provide informed consent.
  • Due to the number of sites across SK, AB, and MB, the diversity of the sites and local teams and the incremental addition of sites as the project progresses, the total number of participants to be recruited over the duration of the study (3 years), will be 10,000 individuals and there will be no requirement on local sample size, for the participating sites. (Please refer to Risks and Benefits). A competitive recruitment process will be in place and monitored closely throughout the study.
  • Individuals > 18 years old
  • Are able to read/understand English or French
  • Are able to provide informed consent
Show all 13Show fewer
  • Are paid employees of the study site(s)
  • Are able to perform the study procedures outlined in the protocol
  • Regulated healthcare professional
  • Are able to read/understand English or French
  • Are able to provide informed consent
  • Are paid employees of the study site(s)
  • Are able to perform the study procedures outlined in the protocol

Who cannot join

  • < 16 years
  • Unable to provide signed informed consent (e.g., intoxicated)
  • Non-Healthcare Professional Operators For the purposes of this study, the untrained non-HCP operators are defined as the personnel, including community health navigators who in the opinion of the Principal Investigator are able to perform the study procedures outlined in this protocol and who are employed by the site. These operators will only be using the investigational device in this study - Multiplo® Complete Syphilis point-of-care test.
  • Individuals < 18 years old
  • Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study
  • Are regulated healthcare professionals including nurses, nurse practitioners, physicians, dentists, pharmacists, and laboratory technologists
  • Healthcare Professional Operators For the purposes of this study, the healthcare professionals are defined as the paid personnel who in the opinion of the Principal Investigator are able to perform the study procedures outlined in this protocol and who are employed by the site.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites
  • Radius Community Health & Healing

    Edmonton, Alberta, T5H 2J2

  • StreetWorks

    Edmonton, Alberta, T5H 2J2

  • Northreach Society

    Grande Prairie, Alberta, T8V 5B6

  • All Nations Hope Network

    Regina, Saskatchewan, S0G1S0

  • Wellness Wheel Clinic

    Regina, Saskatchewan, S4T 0L6

  • Siloam Mission

    Winnipeg, Manitoba, R3B 1M3

  • Ka Ni Kanichihk

    Winnipeg, Manitoba, R3G 0R8

  • Nine Circles Community Health Centre

    Winnipeg, Manitoba, R3G 0X2

Other trials in Canada

About this study

Official title: REACHing Underserved and Undiagnosed Populations Living with Syphilis and HIV in Alberta, Saskatchewan, Manitoba and Northern Communities: "Test, Treat and Linkage to Culturally Appropriate Care"

The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities.

Read the detailed description

The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan), reaching 10,000 people in underserved communities.

The study aims to recruit 10,000 people who are attending clinics for routine sexually transmitted and blood-borne testing in those provinces with opportunities for them to receive immediate treatment for syphilis, and culturally appropriate care and treatment for syphilis and HIV.

The primary objective is develop, implement and evaluate community-based models for "testing, treatment and linkages to care" for HIV and syphilis for those who are undiagnosed and underserved in the Prairie provinces.

The secondary objectives are:

Evaluate diagnostic performance of the investigational syphilis standalone POC test to standard testing.

Test the accuracy and usability of the investigational syphilis standalone POC test by intended users.

Assess the impact of POC testing on time to diagnosis, treatment, and connect to a clinical provider.

Investigate the feasibility and acceptability of the POC test among healthcare providers and at-risk populations.

Examine the acceptability of syphilis and HIV POC tests among at-risk and underserved populations.

Critical to the success of this, the study will engage and support people with lived experiences, peer navigators and leaders from community-based agencies to be involved in all aspects of this work.

Being tested
INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test, Multiplo Complete Syphilis (TP/nTP) Antibody Test
Keywords
HIV, syphilis, Point-of-care, Point-of-care testing, POC testing, Community-based
Medical subject headings
Syphilis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSTI HIV-1/2 Antibody TestDevice

    The INSTI HIV-1/HIV-2 Antibody Test is a single use, rapid, in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and/or Type 2 (HIV-1/HIV-2) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The test is intended for use by trained personnel in point of care and laboratory situations to aid in the diagnosis of HIV infections. If multiple rapid HIV tests are available, this test is suitable for use in appropriate multi-test algorithms.

  • INSTI Multiplex HIV-1/2 Syphilis Antibody TestDevice

    The INSTI MULTIPLEX HIV-1/2 Syphilis Ab Test is a single use, rapid, flow-through in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1/ Type 2 and Treponema pallidum in human fingerstick blood and serum. The INSTI Multiplex 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 one minute. Although suitable for near-patient point-of-care (POC) testing, the INSTI Multiplex Test is not suitable for self-testing.

  • Multiplo Complete Syphilis (TP/nTP) Antibody TestDevice

    Multiplo Complete Syphilis (TP/nTP) Antibody Test (Multiplo® TP/nTP) is a single use, manually performed, visually interpreted, qualitative immunoassay based on Rapid Vertical Flow Technology® for the detection of antibodies to Treponema pallidum (TP), the causative agent of syphilis, and to nontreponemal (nTP; [RPR titer ≥ 1:8]) antigens in human serum, plasma, or fingerstick whole blood specimens. Nontreponemal antibodies are called reagins and they are generated after the tissue damage caused by syphilis infection.

    Multiplo® TP/nTP is intended for use by healthcare professionals as an aid in the diagnosis of active syphilis infection.

Study groups in NCT06893159
Study groupRoleWhat they receive
PatientsExperimentalPatients will be anyone presenting at the community site clinics for regular STI testing
Receives: Device: INSTI HIV-1/2 Antibody Test; Device: INSTI Multiplex HIV-1/2 Syphilis Antibody Test; Device: Multiplo Complete Syphilis (TP/nTP) Antibody Test
Healthcare ProfessionalsNo interventionHealthcare professionals (e.g., nurses) that will conduct patient intake, consent patients, provide POC testing (test operators), and provide treatment and linkage to care where necessary.
Non-Healthcare ProfessionalsNo interventionNon-Healthcare Professionals (e.g., health navigators that are peers with lived experiences) that will conduct community outreach, and for sites that are doing non-healthcare professional testing, the health navigators will conduct patient intake, consent patients, provide POC testing (test operators), and link patients to treatment where necessary.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis)

    Diagnostic performance of POC T Pallidum antibody and non-T Pallidum antibody test results will be compared to standard laboratory testing results for each marker, and test performance characteristics with 95% binomial confidence intervals will be calculated for sensitivity and specificity. In addition, diagnostic performance for TP antibody detection will be stratified by RPR titre (non-reactive, 1:1, 1:2, 1:4, >1:8 dilutions). Serial, parallel serology will be collected at the time of every syphilis POCT. Serology is the gold standard to diagnose syphilis and aids in determining staging and thus, treatment. Serial testing will aid whether syphilis POCT may be utilized in a more comprehensive manner, to possibly replace serology in some settings where access may be a challenge.

    Measured: 3 years

Secondary outcomes (5)
  1. Time to Diagnosis, Treatment, and Linkage to HIV Care Following Point-of-Care Testing vs. Standard Testing

    Assess the time to diagnosis, time to treatment, and time to HIV care linkage following point-of-care testing for syphilis and HIV compared to standard laboratory testing. Time to diagnosis and treatment will be measured in days from test administration to diagnosis and from diagnosis to treatment, respectively. For HIV, time to linkage to care will be measured in days from diagnosis to first consultation with an infectious disease specialist.

    Data will be stratified by age, gender, and testing location, and analyzed using survival analysis or Poisson/negative binomial regression. Comparisons will be made between POC and standard testing with statistical significance determined by a p-value of <0.05.

    Measured: 3 years

  2. Proportion of Patient Consenting vs. Declining (Patient Acceptability of Point-of-Care Testing )

    To evaluate the acceptability and feasibility of POC among different populations for syphilis (and HIV if applicable) among at risk and underserved populations, specifically patient acceptability and experiences with POC.

    Patient acceptability will be calculated as the proportion of individuals consenting to POCT divided by the total number of participants offered POC testing. To determine differences between participants consenting and those declining POC testing, age, gender, and testing location will be compared using chi-square for categorical variables and Mann-Whitney U test for age. A two-sided p value of < 0.05 will be considered statistically significant.

    Measured: 3 years

  3. Descriptive Analysis of Healthcare Provider Feasibility and Acceptability of Point-of-Care Testing

    Healthcare providers will complete a survey after point-of-care testing assessing their experience using the test (e.g., ease of use, ease of interpretation of results). A descriptive analysis of healthcare provider experience survey will be conducted.

    Measured: 3 years

  4. Descriptive Analysis of Patient Experience and Satisfaction of Point-of-Care Testing

    Patients will complete a survey after point-of-care testing assessing their experience (e.g., comfort levels, recommend to others, ease of testing process).

    A descriptive analysis of the patient experience survey will be completed and stratified by negative and positive results by test type.

    Measured: 3 years

  5. Demographic Associations with Syphilis and HIV Point-of-Care Test Outcomes (Reactive vs. Non-Reactive Results)

    Analyze the associations between demographic factors (such as age, gender, and testing location) and syphilis and HIV point-of-care test outcomes, focusing on the correlation between demographics and reactive versus non-reactive test results. Chi-square analysis will be used to assess these associations, with stratification by POC test type when sample sizes allow. A two-sided p-value of <0.05 will be considered statistically significant.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2025
  2. Study start1 Feb 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Screening for HIV and syphilis infection using 3 point-of-care devices by healthcare providers and non-healthcare providers at community-based clinical sites.
Masking
None (open label)
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06893159
Sponsor's protocol ID
REACH-SPOR-001
Acronym
AI
Status last verified
Jan 2025
First submitted
27 Feb 2025
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test and Multiplo Complete Syphilis (TP/nTP) Antibody Test in people with Point-of-Care Testing and HIV, run by Unity Health Toronto at 8 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 13 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

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?

Proportion of True Positives and True Negatives in Point-of-Care Syphilis Testing Compared to Standard Laboratory Testing (Sensitivity and Specificity Analysis) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Mar 2025.

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