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

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

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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).

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Kristin Wall, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2029-06-30

Completion

2030-06-30

FDA Device

Yes

Countries

• United States

Study Locations