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

Официальное название

Improving Maternal and Child Health Through Point-of-care STI Testing (MATCH-POINT)

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Point-of-care STI tests
  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 Sexua
• Диагностический тест Standard of care STI testing
  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).

Первичные конечные точки

• Time to treatment [Срок оценки: Baseline (STI testing), up to pregnancy completion (up to 41 weeks)]

Вторичные конечные точки (9)

• Time to STI treatment completion [Срок оценки: Baseline (STI diagnosis) and 1 month follow-up]
• Repeat STI positives [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]
• Stillbirths [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]
• Miscarriage [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]
• Ectopic pregnancy [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]
• Preterm Birth [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]
• Pre mature rupture of membranes [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]
• Chorioamnionitis [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]
• Postpartum endometritis [Срок оценки: Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Grady Memorial Hospital — Atlanta

Идентификаторы

NCT: NCT07290439 · 2025P013591 · R01MD020754

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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