NCT07290439 · Emory University
Improving Maternal and Child Health Through Point-of-care STI Testing
(MATCH-POINT)
What this study is about
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.
View original scientific 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
DIAGNOSTIC_TEST
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 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.
DIAGNOSTIC_TEST
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).
Primary outcome measures
Time to treatment
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations