Point-of-care STI testing to speed treatment in pregnant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares point-of-care testing (POCT) for sexually transmitted infections with standard lab-based testing in pregnant patients at a large safety-net hospital. It aims to measure time to treatment, feasibility, acceptability, and cost-effectiveness of implementing POCTs in prenatal and obstetric care. Participants are randomly or sequentially assigned to receive POCTs via fingerstick blood or vaginal swab or receive standard lab testing, with follow-up surveys about a month later. Stakeholders including providers, hospital leadership, and public health officials will contribute to understanding barriers and facilitators to POCT implementation. The trial addresses disparities in STI burden and aims to demonstrate whether same-day results can improve reproductive outcomes.

Why it matters

Who can join: the full rules

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 it's running

• Grady Memorial Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Kristin Wall, PhD — Emory University
• Study coordinator: Kristin Wall, PhD
• Email: kmwall@emory.edu
• Phone: (404)-616-0600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rapid gonorrhoea test for pregnant and symptomatic women in East London, South Africa

  This project will test a quick point-of-care gonorrhoea test to see if it accurately detects infection in pregnant and symptomatic women attending clinics in East London, South Africa.

  Recruiting Foundation for Professional Development (Pty) Ltd · East London, Eastern Cape · NCT07530406

• Routine STI screening during pregnancy to improve birth outcomes

  This study tests whether adding screening and treatment for chlamydia and gonorrhoea to standard antenatal care can reduce preterm birth and other problems for pregnant women in Botswana.

  Recruiting University of California, San Diego · Gaborone · NCT07458802

• New ALPCO blood tests to detect syphilis antibodies

  This will test two ALPCO blood tests that look for treponemal and non-treponemal antibodies in people screened for or suspected of having syphilis, including pregnant and HIV-positive individuals.

  Recruiting at 6 sites American Laboratory Products Company · Lancaster, California and 5 other locations · NCT07089836

• Investigating the link between sexually transmitted infections and female infertility

  This study is trying to see if sexually transmitted infections affect fertility in young women aged 18-22 by looking at their vaginal health over time.

  Recruiting University of Luebeck · Lübeck · NCT05244967

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.