CompletedNot Applicable

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

United States149 participantsStarted 2025-09-30

Plain-language 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.

Who can participate

Age range

14 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants that completed screening

Timeframe: end of study (15 minutes after baseline)

Number of participants that tested positive for syphilis

Timeframe: end of study (15 minutes after baseline)

Number of participants that tested positive for HIV

Timeframe: end of study (15 minutes after baseline)

Number of participants that tested positive for syphilis and HIV

Timeframe: end of study (15 minutes after baseline)

Number of participants that received treatment

Timeframe: end of study (15 minutes after baseline)

Trial details

NCT IDNCT07498153

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-02

View on ClinicalTrials.gov More Syphilis trials

Plain-language summary

Who can participate

Age range

14 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants that completed screening

Timeframe: end of study (15 minutes after baseline)

Number of participants that tested positive for syphilis

Timeframe: end of study (15 minutes after baseline)

Number of participants that tested positive for HIV

Timeframe: end of study (15 minutes after baseline)

Number of participants that tested positive for syphilis and HIV

Timeframe: end of study (15 minutes after baseline)

Number of participants that received treatment

Timeframe: end of study (15 minutes after baseline)