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

RecruitingNA

Sponsor: Emory University

Conditions: Treponema Pallidum Infection, Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Trichomonas Vaginalis Vaginitis, Sexually Transmitted Infection

Interventions: Point-of-care STI tests, Standard of care STI testing

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Atlanta, Georgia, United States