Improving Maternal and Child Health Through Point-of-care STI Testing
Purpose
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
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Atlanta, Georgia 30303
More Details
- Status
- Recruiting
- Sponsor
- Emory University
Detailed Description
Sexually transmitted infections (STIs) represent a growing public health crisis in the United States, with disproportionate impact among Black women and women residing in the Southeastern region. National surveillance data demonstrate alarming increases in syphilis, with reported cases rising by 937% and congenital syphilis cases increasing by 755% over the past decade. In pregnant women, untreated or delayed treatment of STIs is associated with severe adverse reproductive outcomes, including stillbirth, preterm birth, and vertical transmission to the infant. At Grady Memorial Hospital (GMH), a large safety-net hospital in Atlanta, Georgia, the current standard of care for syphilis diagnosis relies on rapid plasma reagin (RPR) screening, confirmatory treponemal testing, and patient history. This process requires patient recontact for counseling, treatment initiation, and partner notification. Similarly, testing for chlamydia (CT), gonorrhea (NG), and trichomonas (TV) is performed using laboratory-based nucleic acid amplification tests (NAATs), which typically require 1-3 days for results. The absence of same-day diagnostic results creates significant barriers to timely treatment, as recontacting patients is often challenging, and transportation or socioeconomic constraints may limit access to care. STI counseling and treatment at GMH are provided by the clinical team in accordance with the Centers for Disease Control and Prevention (CDC) STI Treatment Guidelines. Recommended regimens include intramuscular benzathine penicillin G (single dose for early syphilis; three weekly doses for latent or unknown duration syphilis), oral azithromycin for chlamydia in pregnancy, intramuscular ceftriaxone for gonorrhea, and a one-week course of oral metronidazole for trichomonas. Patients with positive results are retested per GMH standard of care, consistent with CDC recommendations. Despite adherence to national guidelines, treatment delays remain common among pregnant women presenting to GMH's outpatient prenatal care (PNC) clinic and Labor & Delivery (L&D) triage. These delays increase risk of onward transmission, including mother-to-child transmission, and contribute to adverse reproductive outcomes. To address these challenges, multidisciplinary experts in obstetrics, infectious diseases, clinical trials, and implementation science at Emory University have developed the **MATCH-POINT study**. This study will evaluate the effectiveness and scalability of point-of-care tests (POCTs) for syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women receiving care at GMH. GMH serves a predominantly under-resourced patient population with high STI prevalence and elevated maternal and child morbidity and mortality. Findings from MATCH-POINT will inform strategies for integrating POCTs into routine prenatal and obstetric care, with the goal of reducing treatment delays, improving maternal and infant outcomes, and preventing onward transmission. Results will be shared with key stakeholders, including the Georgia Department of Public Health, to guide recommendations for broader implementation and scalability of POCTs across safety-net hospitals and clinics serving under-resourced pregnant women throughout the Southeastern United States.