Skip to main content
OpenTrials
Completed

NCT Number: NCT07498153

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

14 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Number of participants that completed screening

    Time frame: end of study (15 minutes after baseline)

  2. Number of participants that tested positive for syphilis

    Time frame: end of study (15 minutes after baseline)

  3. Number of participants that tested positive for HIV

    Time frame: end of study (15 minutes after baseline)

  4. Number of participants that tested positive for syphilis and HIV

    Time frame: end of study (15 minutes after baseline)

  5. Number of participants that received treatment

    Time frame: end of study (15 minutes after baseline)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.