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.
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)
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
Emory University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator