NCT07498153

Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a strategy utilizing the Chembio HIV/syphilis rapid point-of-care (POC) test for diagnosis of HIV and syphilis in pregnant women attending prenatal clinics in Guatemala will increase screening and detection rates thereby resulting in higher rates of treatment during pregnancy and ultimately reducing congenital syphilis and HIV Mother-to-child transmission (MTCT) and to provide knowledge and technical expertise on the use of Point-of-care ultrasound for all pregnant patients testing positive for syphilis during the intervention to evaluate the fetus for evidence of congenital syphilis.

Conditions

• Syphilis
• HIV Infections

Interventions

Type	Name	Description
DEVICE	Chembio HIV/Syphilis rapid POC test	Participants will undergo the Chembio DPP® HIV-Syphilis rapid POC test by fingerstick. The Chembio test is read by a handheld reader. If positive for syphilis, the participant ill be informed and treated at the same visit with intramuscular (IM) Benzathine penicillin G (BPG) according to clinical stage and will undergo point-of-care ultrasound for the detection of fetal markers for congenital syphilis.If positive for HIV, participant will be started on Bictegravir/Tenofovir Alafenamide (TAF)/Emtricitabine (FTC) per guidelines

Timeline

• Start date: 2025-09-30
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study