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Improving Maternal and Child Health Through Point-of-care STI Testing

Sponsor: Emory University • ClinicalTrials.gov ID: NCT07290439

Registry updated: 2026-08-19

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Description

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.

Interventions

Point-of-care STI tests (Diagnostic test)
Point-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 test)
Standard 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).

Eligibility criteria

Inclusion Criteria: * Pregnant and clinically indicated for STI testing (syphilis and/or Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) at a prenatal care (PNC ) or labor and delivery (L\&D) triage visit at Grady Memorial Hospital (GMH). Indications for STI testing in pregnancy at GMH: * 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) * English or Spanish-speaking * If \<16 years of age, has a parent or legal guardian present * Have STI risk factor: * \<25 years of age * Reports current substance use * Reported or documented history of a positive STI * More than one current sex partner * A current sex partner who has concurrent partners * A new sex partner (\<6 months ) * A current sex partner who has an STI * Exchange of sex for money or drugs * Incarceration * No previous prenatal care during the current pregnancy * Able to follow study procedures and provide written informed consent or assent, as appropriate Exclusion Criteria: * 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 Stakeholders: * GMH PNC or L\&D providers, GMH leadership, Georgia Dept of Health leadership * \>=18 years of age * Able to follow study procedures and provide verbal informed consent

Conditions

Treponema Pallidum Infection Chlamydia Trachomatis Infection Neisseria Gonorrheae Infection Trichomonas Vaginalis Vaginitis Sexually Transmitted Infection

Locations

Grady Memorial Hospital — Atlanta, Georgia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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