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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.
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.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
February 1, 2025
Primary Completion Date
December 1, 2027
Completion Date
March 1, 2028
Last Updated
March 25, 2025
10,000
ESTIMATED participants
INSTI HIV-1/2 Antibody Test
DEVICE
INSTI Multiplex HIV-1/2 Syphilis Antibody Test
DEVICE
Multiplo Complete Syphilis (TP/nTP) Antibody Test
DEVICE
Lead Sponsor
Unity Health Toronto
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07071623