An interventional study of Point-of-care STI tests and Standard of care STI testing in Treponema Pallidum Infection, Chlamydia Trachomatis Infection and Neisseria Gonorrheae Infection, sponsored by Emory University. Recruiting at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Emory University · Not applicable, Interventional, and Diagnostic
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:
Participants will:
Sexually transmitted infections (STIs) represent a growing public health crisis in the United States, with disproportionate impact among Black women and women residing in the Southeastern region. National surveillance data demonstrate alarming increases in syphilis, with reported cases rising by 937% and congenital syphilis cases increasing by 755% over the past decade. In pregnant women, untreated or delayed treatment of STIs is associated with severe adverse reproductive outcomes, including stillbirth, preterm birth, and vertical transmission to the infant.
At Grady Memorial Hospital (GMH), a large safety-net hospital in Atlanta, Georgia, the current standard of care for syphilis diagnosis relies on rapid plasma reagin (RPR) screening, confirmatory treponemal testing, and patient history. This process requires patient recontact for counseling, treatment initiation, and partner notification. Similarly, testing for chlamydia (CT), gonorrhea (NG), and trichomonas (TV) is performed using laboratory-based nucleic acid amplification tests (NAATs), which typically require 1-3 days for results. The absence of same-day diagnostic results creates significant barriers to timely treatment, as recontacting patients is often challenging, and transportation or socioeconomic constraints may limit access to care.
STI counseling and treatment at GMH are provided by the clinical team in accordance with the Centers for Disease Control and Prevention (CDC) STI Treatment Guidelines. Recommended regimens include intramuscular benzathine penicillin G (single dose for early syphilis; three weekly doses for latent or unknown duration syphilis), oral azithromycin for chlamydia in pregnancy, intramuscular ceftriaxone for gonorrhea, and a one-week course of oral metronidazole for trichomonas. Patients with positive results are retested per GMH standard of care, consistent with CDC recommendations.
Despite adherence to national guidelines, treatment delays remain common among pregnant women presenting to GMH's outpatient prenatal care (PNC) clinic and Labor \& Delivery (L\&D) triage. These delays increase risk of onward transmission, including mother-to-child transmission, and contribute to adverse reproductive outcomes.
To address these challenges, multidisciplinary experts in obstetrics, infectious diseases, clinical trials, and implementation science at Emory University have developed the **MATCH-POINT study**. This study will evaluate the effectiveness and scalability of point-of-care tests (POCTs) for syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women receiving care at GMH. GMH serves a predominantly under-resourced patient population with high STI prevalence and elevated maternal and child morbidity and mortality.
Findings from MATCH-POINT will inform strategies for integrating POCTs into routine prenatal and obstetric care, with the goal of reducing treatment delays, improving maternal and infant outcomes, and preventing onward transmission. Results will be shared with key stakeholders, including the Georgia Department of Public Health, to guide recommendations for broader implementation and scalability of POCTs across safety-net hospitals and clinics serving under-resourced pregnant women throughout the Southeastern United States.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 756 is above the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Have STI risk factor:
Exclusion Criteria:
Stakeholders:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo routine clinical care at Grady Memorial Hospital (GMH), consistent with CDC STI Treatment Guidelines. * Positive results will be communicated via phone and/or Patient Portal. * For trichomoniasis or chlamydia, treatment will involve sending a prescription to the patient's preferred pharmacy. For syphilis or gonorrhea, patients will be asked to return to the clinic for an antibiotic infection.
Diagnostic Test: Standard of care STI testing
If participants wait for POCT results: * Positive results will prompt same-day counseling and treatment. * Treatment will be directly observed for gonorrhea and syphilis, or provided as a same-day prescription for trichomonas. * Chlamydia treatment may be directly observed or prescribed, depending on the clinical setting, consistent with the standard of care. If participants do not wait for POCT results: * Positive results will be communicated via phone and/or Patient Portal. * Treatment will proceed as in the standard-of-care control arm.
Diagnostic Test: Point-of-care STI tests · Diagnostic Test: Standard of care STI testing
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 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).
Also known as: SOC
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 frame: Baseline (STI testing), up to pregnancy completion (up to 41 weeks)
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
Time frame: Baseline (STI diagnosis) and 1 month follow-up
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.
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Stillbirths
The number of stillbirths will be reported. This is defined as fetal death occurring at ≥20 weeks' gestation.
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Miscarriage
The number of miscarriages will be reported. This is defined as a spontaneous loss of pregnancy before 20 weeks' gestation.
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Ectopic pregnancy
Number of ectopic pregnancies will be reported. This is defined as implantation of the pregnancy outside the uterine cavity (e.g., fallopian tube, ovary, abdominal cavity).
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Preterm Birth
Number of preterm births will be reported. This is defined as live birth occurring before 37 completed weeks of gestation.
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Pre mature rupture of membranes
Number of cases of premature rupture of membranes (PROM) will be reported. This is defined as spontaneous rupture of amniotic membranes before the onset of labor.
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Chorioamnionitis
Number of cases of chorioamnionitis will be reported. This is defined as intra-amniotic infection characterized by maternal fever plus clinical signs (e.g., uterine tenderness, maternal/fetal tachycardia, purulent amniotic fluid).
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Postpartum endometritis
Number of cases of postpartum endometritis will be reported. This is defined as infection of the endometrium occurring after delivery, typically presenting with fever, uterine tenderness, and foul-smelling lochia
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
Plan to share: Yes — Minimal, de-identified datasets sufficient to recreate primary analyses will be made publicly available in the repository. The raw data and a data dictionary will be made available in the repository.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be deposited after publication of the primary outcome findings
Access criteria: Under a data sharing agreement, quantitative analyses will be shared with Harvard Dataverse
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2029, 34 months after the start.
Of 25 interventional studies with no phase under Syphilis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 34 months is above that.
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