Improving Maternal and Child Health Through Point-of-care STI Testing (NCT07290439) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Improving Maternal and Child Health Through Point-of-care STI Testing
United States756 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to treatment
Timeframe: Baseline (STI testing), up to pregnancy completion (up to 41 weeks)