Recruiting

Point-of-Care Tests

Sponsor:

Emory University

Code:

NCT07290439

Conditions

Treponema Pallidum Infection

Chlamydia Trachomatis Infection

Neisseria Gonorrheae Infection

Trichomonas Vaginalis Vaginitis

Sexually Transmitted Infection

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Point-of-care STI tests

Standard of care STI testing

Study Details

Brief 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.

Conditions

Treponema Pallidum Infection

Chlamydia Trachomatis Infection

Neisseria Gonorrheae Infection

Trichomonas Vaginalis Vaginitis

Sexually Transmitted Infection

Study ID

NCT07290439

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

756 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Control 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 infection.

experimental: Intervention 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:

  • Positive results will be communicated via phone and/or Patient Portal.
  • Treatment will proceed as in the standard-of-care control arm.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Kristin Wall, PhD

(404)-616-0600kmwall@emory.edu

Kimberly Workowski, MD

kworkow@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Kimberly Workowski, MD

404-686-7893kworkow@emory.edu

Principal Investigator:

Kimberly Workowski, MD

More Information

Sponsor

Emory University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Prenatal care
  • Point of care test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-19.