Maternity Centre of Hamilton
Hamilton, Ontario, Canada
Location status: Recruiting
NCT Number: NCT06829602
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).
Interested in participating?
Request Info13 year–49 year
All sexes
Interventional
Not applicable
Hamilton, Ontario, Canada
Location status: Recruiting
Early testing and treatment for syphilis during pregnancy, along with treating sexual partners, can prevent infection of the baby (known as congenital syphilis). However, many pregnant people at risk of syphilis also face barriers to prenatal care due to social determinants of health such as substance use and unstable housing. These barriers may lead to delays in management of syphilis in pregnancy, which may result in poor maternal and infant health outcomes.
A major issue is the standard syphilis blood test. This test takes about a week to return results. This delay makes it difficult to communicate positive results to people with limited phone or internet access, and it can be hard for people to return for treatment. Additionally, it may be challenging to take blood for the syphilis test from people whose veins are damaged from intravenous drug use. As a result, syphilis diagnosis and/or treatment in pregnancy may be delayed or missed altogether.
Health Canada has approved a point-of-care test for syphilis and HIV that uses a finger-prick blood sample and gives results in 5 minutes. This rapid test enables same-day syphilis treatment initiation with intramuscular penicillin antibiotic, and could overcome some of the barriers described above. However, point-of-care syphilis testing has not been studied in pregnant people facing barriers to prenatal care.
An urban low-barrier prenatal clinic (Maternity Centre of Hamilton) will implement the point-of-care syphilis/HIV test as part of regular care. The test will be offered to pregnant clients at risk of syphilis, and to the sexual partners of syphilis-positive pregnant clients, given the critical importance of treating partners to prevent re-infection during pregnancy. Over 1 year, the study will evaluate the feasibility of test implementation, in terms of acceptability by clients and test performance by clinicians. The study will also preliminarily assess whether the point-of-care test improves timeliness and adequacy of treatment of syphilis-positive pregnant clients and their sexual partners. The investigators did not feel it was ethical to have a control group with delayed access to point-of-care testing given the potential harms of delayed diagnosis of syphilis in pregnancy; rather, baseline data regarding management of syphilis in pregnancy at the clinic will be established using retrospective chart review, and compared to syphilis management over the study period.
Importantly, if pregnant clients or sexual partners decline study participation, they are still eligible for point-of-care testing to learn their syphilis and HIV status.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inclusion criteria
Exclusion criteria
The INSTI Multiplex HIV/Syphilis Duo Antibody Test is a rapid immunoassay that can detect HIV and syphilis antibodies in the blood using finger-prick blood samples. The test is Health Canada-approved.
Time frame: Single time-point - At time of first offer of point-of-care test - approximately 5 minutes
Time frame: From the first prenatal clinic visit until the end of pregnancy - up to 8 months
Time frame: Single time-point - at time of post-test survey - approximately 5 minutes
Time frame: Single time-point - at time of post-test survey - approximately 5 minutes
Time frame: From initiation to completion of point-of-care test - approximately 5 minutes
Time frame: From initiation to completion of point-of-care test - approximately 5 minutes
Time frame: From positive syphilis point-of-care test result until end of clinic visit - up to 3 hours
Time frame: From the day of syphilis testing to notification of client - range 5 minutes to 8 months
Time frame: From the day of syphilis testing to treatment of client - range 5 minutes to 8 months
Time frame: From the day of syphilis testing to end of pregnancy - up to 8 months
Time frame: From the day of syphilis testing to treatment of client - up to 8 months
Time frame: From the day of pregnant person's syphilis testing to treatment of partner - range 1 hour to 8 months
Time frame: From the day of pregnant person's syphilis testing to treatment of partner - up to 8 months
Time frame: From the day of pregnant person's syphilis testing to treatment of partner - up to 8 months
Contact information is provided by the study sponsor or research team.
McMaster University
Other
PREnatal Syphilis Point-of-care ScreenING in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial
Acronym: PRESSING
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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