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

NCT07498153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-08-28

Study results available
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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

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Irene A Stafford, M.D., M.S., M.P.H · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-10-02
Completion
2025-10-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498153 on ClinicalTrials.gov