The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women. It will also learn about the feasibility, acceptability, and cost-effectiveness of implementing POCTs in a large safety-net hospital setting.
The main questions it aims to answer are:
* Do POCTs reduce delays in STI treatment compared with standard laboratory-based testing? * What barriers, facilitators, and processes affect POCT implementation in prenatal and obstetric care? * What are the costs and cost-effectiveness of POCTs compared with standard testing?
Participants will:
* Complete a baseline survey and receive either POCTs (fingerstick blood draw or vaginal swab) or standard laboratory STI testing. * If diagnosed with an STI, complete a follow-up survey approximately one month later. * Stakeholders (providers, hospital leadership, and public health officials) will complete interviews to inform implementation strategies.
Syphilis, CT, NG, and TV indicated at first PNC visit
Syphilis serologic testing additionally indicated in 3rd trimester and at delivery
CT/NG/TV additionally indicated in the 3rd trimester for those <25 or with increased risk [1]
Additional testing recommended based on clinical signs or symptoms (e.g., genital lesion or vaginal discharge, new exposure history)
Indicated for syphilis test: negative RPR test during this pregnancy
Indicated for syphilis test: ever had a previous syphilis diagnosis (lifetime history)
Indicated for CT/NG/TV test: negative for all three of CT, NG, and TV within the previous 1 month
Indicated for CT/NG/TV test: positive for any of CT, NG, and/or TV and completed treatment <3 weeks prior
Parallel
Point-of-care STI tests
Diagnostic testPoint-of-care testing for syphilis and/or chlamydia, gonorrhea, and trichomonas, depending on clinical indication at the visit. Testing will be performed using the Syphilis Health Check (SHC) and/or the Visby Sexual Health Test. * Syphilis Health Check (SHC) * Single-use, disposable, fully integrated rapid test. * Provides results in approximately 10 minutes. * Detects syphilis antibodies (IgM and IgG to treponemal antigens) from fingerstick, whole blood, serum, or plasma. * Visby Sexual Health Test (Visby Medical): * Single-use, disposable, fully integrated rapid PCR-based assay. * Provides results in \<30 minutes. * Detects Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis from vaginal swabs.
Standard of care STI testing
Diagnostic testStandard of care for STI testing Testing procedures: * Blood samples will be collected for syphilis screening using rapid plasma reagin (RPR) with reflex treponemal testing. * Vaginal swab samples will be collected for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) testing using nucleic acid amplification tests (NAATs).
Time to treatment
Percentage of participants with onset of treatment within 1 week vs in more than a weeks time frame. Time from STI diagnosis to medication administered (syphilis, NG, and some CT infections) or prescription written (TV and some CT infections)
Time to STI treatment completion
Time between STI diagnosis and: * Treatment completion * Prescriptions being filled * Partner STI treatment Pregnancy outcomes Follow-up testing Linkage to care
Repeat STI positives
Number of participants testing positive for the same infection documented a second time meeting the following criteria: there was documentation of appropriate treatment between those diagnoses, and there were at least 4 weeks between tests.
Stillbirths
The number of stillbirths will be reported. This is defined as fetal death occurring at ≥20 weeks' gestation.
Miscarriage
The number of miscarriages will be reported. This is defined as a spontaneous loss of pregnancy before 20 weeks' gestation.
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Emory University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
