Ayaangwaamiziwin Initiative: Carefulness and Preparedness
NCT ID: NCT06893159
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
10000 participants
INTERVENTIONAL
2025-02-01
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multiplo Tp/HIV Self-Test
NCT06716450
Evaluation of Enhanced Syphilis Screening Among HIV-positive Men
NCT02019043
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
NCT03637244
Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi
NCT06200545
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
NCT05307991
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients
Patients will be anyone presenting at the community site clinics for regular STI testing
INSTI HIV-1/2 Antibody Test
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 Test
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 Test
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.
Healthcare Professionals
Healthcare 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.
No interventions assigned to this group
Non-Healthcare Professionals
Non-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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INSTI HIV-1/2 Antibody Test
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 Test
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 Test
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
1. Individuals \> 18 years old
2. Are able to read/understand English or French
3. Are able to provide informed consent
4. Are paid employees of the study site(s)
5. Are able to perform the study procedures outlined in the protocol
1. Regulated healthcare professional
2. Are able to read/understand English or French
3. Are able to provide informed consent
4. Are paid employees of the study site(s)
5. Are able to perform the study procedures outlined in the protocol
Exclusion Criteria
2. 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.
1. Individuals \< 18 years old
2. Have used or watched someone use the Multiplo® Complete Syphilis Test prior to this study
3. 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.
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Unity Health Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radius Community Health & Healing
Edmonton, Alberta, Canada
StreetWorks
Edmonton, Alberta, Canada
Northreach Society
Grande Prairie, Alberta, Canada
Siloam Mission
Winnipeg, Manitoba, Canada
Ka Ni Kanichihk
Winnipeg, Manitoba, Canada
Nine Circles Community Health Centre
Winnipeg, Manitoba, Canada
All Nations Hope Network
Regina, Saskatchewan, Canada
Wellness Wheel Clinic
Regina, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REACH-SPOR-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.