רדאר קליני AI
הניסוי הקליני NCT07290439 (MATCH-POINT) עבור Treponema Pallidum Infection, זיהום כלמידיה טרכומטיס, זיהום בנייסריה גונוריאה, Trichomonas Vaginalis Vaginitis, זיהום מין הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים
חזרה לחיפוש

Improving Maternal and Child Health Through Point-of-care STI Testing (MATCH-POINT) 756 הריון

טרם החל גיוס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07290439 (MATCH-POINT) הוא מחקר מסוג התערבותי עבור Treponema Pallidum Infection, זיהום כלמידיה טרכומטיס, זיהום בנייסריה גונוריאה, Trichomonas Vaginalis Vaginitis, זיהום מין, שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 במאי 2026, במטרה לכלול 756 משתתפים. המחקר ינוהל על ידי אוניברסיטת אמורי וצפוי להסתיים ב-1 ביוני 2030. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-18 בדצמבר 2025.
סיכום קצר

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...
הצג עוד
תיאור מפורט
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 treatme...הצג עוד
כותרת רשמית

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

מצבים רפואיים
Treponema Pallidum Infectionזיהום כלמידיה טרכומטיסזיהום בנייסריה גונוריאהTrichomonas Vaginalis Vaginitisזיהום מין
מזהי מחקר נוספים
מספר NCT
NCT07290439
תחילת המחקר (בפועל)
2026-05
עדכון אחרון שפורסם
2025-12-18
סיום המחקר (מוערך)
2030-06
משתתפים (מתוכנן)
756
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
טרם החל גיוס
מילות מפתח
Prenatal care
Point of care test
מטרה ראשית
אבחנה
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
משווה פעילControl arm
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 infectio...הצג עוד
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).
ניסיIntervention arm
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: * Positiv...הצג עוד
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 tre...הצג עוד
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).
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
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)
Baseline (STI testing), up to pregnancy completion (up to 41 weeks)
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
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
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.
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.
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.
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).
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.
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.
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).
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
Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
ילד, מבוגר, גיל שלישי
מגדרים מוערכים למחקר
נקבה
מתנדבים בריאים מתקבלים
כן

  • 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

  • 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
Emory University logoאוניברסיטת אמורי
National Institute on Minority Health and Health Disparities (NIMHD) logoNational Institute on Minority Health and Health Disparities (NIMHD)
הגורם האחראי למחקר
Kristin Wall, חוקר ראשי, Associate Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Kristin Wall, PhD, (404)-616-0600, [email protected]
איש קשר: Kimberly Workowski, MD, [email protected]
1 מיקומי המחקר ב-1 מדינות

Georgia

Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
Kimberly Workowski, MD, איש קשר, 404-686-7893, [email protected]
Kimberly Workowski, MD, חוקר ראשי