Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Location contact
Kimberly Workowski, MD
CONTACT
Kimberly Workowski, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07290439
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.
Trial opening soon.
Get NotifiedFemale
Interventional
Not applicable
Atlanta, Georgia, 30303, United States
Kimberly Workowski, MD
CONTACT
Kimberly Workowski, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stakeholders:
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.
Standard of care for STI testing
Testing procedures:
Other names: SOC
Time frame: Baseline (STI testing), up to pregnancy completion (up to 41 weeks)
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 diagnosis) and 1 month follow-up
Time between STI diagnosis and:
Time frame: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
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)
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)
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)
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)
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)
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)
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)
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
Contact information is provided by the study sponsor or research team.
Kimberly Workowski, MD
CONTACT
Kristin Wall, PhD
CONTACT
Emory University
Other
Improving Maternal and Child Health Through Point-of-care STI Testing (MATCH-POINT)
Acronym: MATCH-POINT
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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