PREnatal Syphilis point-of-care ScreenING in an urban low-barrier clinic (PRESSING) study: Protocol for a prospective single arm feasibility trial

Introduction Syphilis has resurged across North America, including syphilis in pregnancy. Congenital syphilis can be prevented by timely treatment of syphilis in pregnancy, but conventional syphilis screening is problematic for people facing barriers to care. Syphilis point-of-care tests (POCT) have improved prenatal syphilis management in low- and middle-income countries. There is minimal literature regarding POCT feasibility and effectiveness for prenatal syphilis screening in high-income countries, where barriers and challenges may differ. Methods Academic and community partners co-designed a prospective single-arm feasibility trial to evaluate syphilis POCT implementation at a low-barrier prenatal clinic in Hamilton, Canada. The INSTI HIV/syphilis POCT was integrated into routine clinical care for pregnant people with ≥1 risk factor for syphilis (unstable housing in the past year; substance use or accessing addictions services in the past year; > 1 sexual partner in the past year; history of sexually transmitted or blood-borne infection; presentation to care >20 weeks gestation). Sexual partners of newly diagnosed pregnant people are also offered POCT. Individuals offered POCT are invited to enroll in the study. The primary feasibility outcome is the proportion of pregnant participants who accept POCT at first offer. Secondary feasibility outcomes include valid POCT results on clinician’s first attempt and accurate POCT interpretation by clinicians. Secondary clinical outcomes include time to treatment initiation and completion of treatment among syphilis-positive participants. To promote inclusion of groups facing structural barriers to research, individuals declining study participation are enrolled for limited prospective chart review (primary feasibility outcome only). Target enrollment is N = 62 pregnant participants over 18 months. Baseline participant characteristics and outcomes will be descriptively analyzed. Community-based knowledge mobilization is ongoing. Conclusion This pilot study will generate novel feasibility data regarding prenatal syphilis screening with POCT in high-income countries and inform design of a multicenter implementation trial. Trial registration Clinicaltrials.gov NCT06829602; February 17, 2025. https://clinicaltrials.gov/study/NCT06829602