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

NCT07290439 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2025P013591R01MD020754
• Study Type: interventional
• Target: 756
• Locations: 1 country
• Sites: 1

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

Keywords

Prenatal care; Point of care test

Outcome Measures

Primary Outcomes (1)

• Time to treatment

  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)

  Baseline (STI testing), up to pregnancy completion (up to 41 weeks)

Secondary Outcomes (9)

• Time to STI treatment completion

  Baseline (STI diagnosis) and 1 month follow-up

• Repeat STI positives

  Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)

• Stillbirths

  Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)

• Miscarriage

  Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)

• Ectopic pregnancy

  Baseline (STI diagnosis) and up to pregnancy completion (up to 41 weeks)

Study Arms (2)

Control arm

ACTIVE COMPARATOR

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.

Diagnostic Test: Standard of care STI testing

Intervention arm

EXPERIMENTAL

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.

Diagnostic Test: Point-of-care STI tests; Diagnostic Test: Standard of care STI testing

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.

Intervention arm

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).

Also known as: SOC

Control arm; Intervention arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Syphilis; Gonorrhea; Trichomonas Vaginitis; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin Wall, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Wall, PhD

CONTACT

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

Kimberly Workowski, MD

CONTACT

kworkow@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 18, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be deposited after publication of the primary outcome findings
• Access Criteria: Under a data sharing agreement, quantitative analyses will be shared with Harvard Dataverse

Locations

US (1)