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

NCT07498153 | Completed FDA Device

• 1 other identifier: HSC-MS-25-0430
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mother-to-child transmission (MTCT); Sexually Transmitted Infections (STI)

Outcome Measures

Primary Outcomes (5)

• Number of participants that completed screening

  end of study (15 minutes after baseline)

• Number of participants that tested positive for syphilis

  end of study (15 minutes after baseline)

• Number of participants that tested positive for HIV

  end of study (15 minutes after baseline)

• Number of participants that tested positive for syphilis and HIV

  end of study (15 minutes after baseline)

• Number of participants that received treatment

  end of study (15 minutes after baseline)

Study Arms (1)

Chembio HIV/Syphilis rapid POC test

EXPERIMENTAL

Device: Chembio HIV/Syphilis rapid POC test

Interventions

Chembio HIV/Syphilis rapid POC test DEVICE

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

Chembio HIV/Syphilis rapid POC test

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women at any gestational age
• Nonpregnant women may also be included if unsure of pregnancy status and attend clinic for pregnancy care and confirmed to be not pregnant by routine testing such as urine pregnancy tests and/or the absence of an intrauterine pregnancy by ultrasound

You may not qualify if:

• Participants not at clinical sites in Puerto Barrios, Guatemala between 09/27/2025 and 10/03/2025

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Syphilis; HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Irene A Stafford, M.D., M.S., M.P.H

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: September 30, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)