Improving Maternal and Child Health Through Point-of-care STI Testing

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07290439
Status
Not Yet Recruiting

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Conditions

  • Chlamydia Trachomatis Infection
  • Neisseria Gonorrheae Infection
  • Sexually Transmitted Infection
  • Treponema Pallidum Infection
  • Trichomonas Vaginalis Vaginitis

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Point-of-care STI tests — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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).

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
756 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Grady Memorial HospitalAtlantaGeorgia30303
Kimberly Workowski, MD
[email protected]
404-686-7893
Kimberly Workowski, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Grady Memorial Hospital· Atlanta, GA

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