PREnatal Syphilis Point-of-care ScreenING in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if a finger-prick blood test for rapid diagnosis of syphilis infection can be implemented in a low-barrier prenatal clinic for people at risk of syphilis in pregnancy. The test gives results in 5 minutes and also tests for HIV. The main questions the study aims to answer are: * How often do pregnant people at risk of syphilis agree to the rapid test? * How well do healthcare providers perform the rapid test? * Does the rapid test speed up diagnosis and treatment of syphilis in pregnant people and their sexual partners? Participants will: * Give feedback about why they did or did not want to take the rapid test, and what their experience was taking the test; and * Share information about their health, pregnancy, and syphilis treatment (if applicable).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 49
Healthy Volunteers: t
View:

⁃ Pregnant clients with at least one risk factor for syphilis infection:

∙ Substance use or accessed addiction services in the past 1 year

‣ Unstable housing in the past 1 year

‣ Multiple sexual partners in the past 1 year

‣ History of a sexually transmitted or blood-borne infection (STBBI)

‣ Late to prenatal care (initial prenatal visit \>20 weeks)

⁃ Eligible for syphilis screening at that clinic visit, as per Public Health guidelines

• Sexual partners of pregnant clients who are newly diagnosed with syphilis

• Physically present in the clinic

Locations
Other Locations
Canada
Maternity Centre of Hamilton
RECRUITING
Hamilton
Contact Information
Primary
Njideka Sanya
sanyan@mcmaster.ca
+1-905-521-2100
Backup
Stacey Clark
clarksta@mcmaster.ca
+1-905-521-2100
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2026-05
Participants
Target number of participants: 77
Treatments
Experimental: Implementation of syphilis/HIV point-of-care testing
The syphilis/HIV point-of-care test will be offered to all prenatal clients with at least 1 risk factor for syphilis, and to the sexual partners of syphilis-positive participants
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: McMaster University

This content was sourced from clinicaltrials.gov