Feasibility Study of Rapid Syphilis and HIV Finger-Prick Testing in a Prenatal Clinic for Pregnant People Facing Care Barriers

What this Trial Is About

Researchers are evaluating the use of a rapid finger-prick blood test that diagnoses syphilis and HIV in pregnant people at risk of syphilis infection, especially those facing barriers to prenatal care. The study aims to find out how often pregnant people agree to the test, how well healthcare providers perform it, and whether it speeds up diagnosis and treatment for pregnant people and their sexual partners. This single-arm feasibility trial is conducted in an urban low-barrier prenatal clinic to improve early treatment and prevent congenital syphilis. The study offers the Health Canada-approved rapid syphilisHIV point-of-care test to pregnant clients with syphilis risk factors and to sexual partners of syphilis-positive clients. The test uses a finger-prick blood sample and delivers results in about 5 minutes, allowing for same-day treatment initiation with intramuscular penicillin when needed. The test is part of regular care and will be evaluated over one year for acceptability and accuracy, with no control group due to ethical concerns about delayed testing. Participants will provide feedback about their experience with the rapid test and share health, pregnancy, and treatment information if applicable. Researchers will measure how many clients accept testing, test performance by clinicians, and timing of diagnosis and treatment. Safety and treatment outcomes for pregnant clients and partners will be tracked up to eight months. The study seeks to improve timely syphilis management for those facing social challenges in prenatal care.

The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care