SyphilisNCT06645106
Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
A study testing Rapid Point of Care (POC) Syphilis testing in people with Syphilis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Syphilis
- What is being tested?
- Rapid Point of Care (POC) Syphilis testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant individuals that are seeking care at University of Texas, Memorial Herman and Lyndon B Johnson sites ED or obstetrical triage units.
- No Prenatal care during index pregnancy
- No documented syphilis result during the index pregnancy
Who cannot join
- Pregnant individuals with documented care and syphilis results in the index pregnancy for specific trimester as mandated by Texas law
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Irene Stafford, MD, 713-500-6412, Irene.Stafford@uth.tmc.edu
Carrie Bakunas, MD, (713) 500-7878, Carrie.A.Bakunas@uth.tmc.edu
About this study
The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.
- Conditions
- Syphilis
- Being tested
- Rapid Point of Care (POC) Syphilis testing
- Keywords
- syphilis diagnostic testing, pregnancy
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Point of Care (POC) Syphilis testingDevice
Participants will undergo the point of care (POC) FDA cleared syphilis health check (SHC) POC test by a research staff using 50 microliters or 1-3 drops of whole blood via finger stick. The analyzer is handheld, and all testing equipment is temperature stable and does not need refrigeration. The SHC-Syphilis results will be available within 10 minutes of receipt given the published turnaround time to results of 15 minutes per package insert and will be recorded as a research note in the electronic medical record (EMR) while the provider assigned to the patient and the Houston Health Department will be notified of results and further treatment will be done if results are positive.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Point of Care (POC) Syphilis testing | Experimental | Not described Receives: Device: Rapid Point of Care (POC) Syphilis testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis
Measured: within 1 week of presentation until the time of delivery
Percentage of patients with no documented syphilis test during the index pregnancy who received full treatment for all stages of syphilis
Measured: within 1 week of presentation until the time of delivery
Secondary outcomes (22)
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up
Measured: within 1 week of presentation until the time of delivery
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up
Measured: at time of postpartum (upto 15 months after delivery)
Percentage of participants that are married on completion of syphilis treatment
Measured: from presentation to delivery
Percentage of participants that have health insurance on completion of syphilis treatment
Measured: from presentation to delivery
Percentage of participants that have psychiatric problems on completion of syphilis treatment
Measured: from presentation to delivery
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment
Measured: from presentation to delivery
Percentage of participants that have unstable housing on completion of syphilis treatment
Measured: from presentation to delivery
Percentage of participants that have transportation on completion of syphilis treatment
Measured: from presentation to delivery
Percentage of participants that experience intimate partner violence on completion of syphilis treatment
Measured: from presentation to delivery
number of prenatal care visits on completion of syphilis treatment
Measured: from presentation to delivery
Percentage of participants that are married on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have health insurance on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have psychiatric problems on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have unstable housing on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have transportation on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
Percentage of participants that experience intimate partner violence on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
number of prenatal care visits on completion of syphilis treatment
Measured: at time of postpartum (upto 15 months after delivery)
Number of birth parents that have reinfection
Measured: from presentation to delivery
Number of birth parents that have reinfection
Measured: at time of postpartum (upto 15 months after delivery)
Number of neonates that have congenital syphilis
Measured: from presentation to delivery
Number of neonates that have congenital syphilis
Measured: at time of postpartum (upto 15 months after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start4 Feb 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Stafford, The University of Texas Health Science Center, Houston
- Investigators
- Irene Stafford, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645106
- Sponsor's protocol ID
- HSC-MS-24-0505
- Status last verified
- May 2026
- First submitted
- 7 Oct 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT06645106
- Acronym / sponsor ID
- HSC-MS-24-0505
- Conditions
- Syphilis
- Keywords
- syphilis diagnostic testing, pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Point of Care (POC) Syphilis testing | Experimental | Device: Rapid Point of Care (POC) Syphilis testing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant individuals that are seeking care at University of Texas, Memorial Herman and Lyndon B Johnson sites ED or obstetrical triage units.
- No Prenatal care during index pregnancy
- No documented syphilis result during the index pregnancy
Key exclusion criteria (1 listed)
- Pregnant individuals with documented care and syphilis results in the index pregnancy for specific trimester as mandated by Texas law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Point of Care (POC) Syphilis testingParticipants will undergo the point of care (POC) FDA cleared syphilis health check (SHC) POC test by a research staff using 50 microliters or 1-3 drops of whole blood via finger stick. The analyzer is handheld, and all testing equipment is temperature stable and does not need refrigeration. The SHC-Syphilis results will be available within 10 minutes of receipt given the published turnaround time to results of 15 minutes per package insert and will be recorded as a research note in the electronic medical record (EMR) while the provider assigned to the patient and the Houston Health Department will be notified of results and further treatment will be done if results are positive. | Device | Rapid Point of Care (POC) Syphilis testing |
Primary outcome
Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis
Time frame: within 1 week of presentation until the time of delivery
Percentage of patients with no documented syphilis test during the index pregnancy who received full treatment for all stages of syphilis
Time frame: within 1 week of presentation until the time of delivery
22 secondary outcomes
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up
Time frame: within 1 week of presentation until the time of delivery
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that are married on completion of syphilis treatment
Time frame: from presentation to delivery
Percentage of participants that have health insurance on completion of syphilis treatment
Time frame: from presentation to delivery
Percentage of participants that have psychiatric problems on completion of syphilis treatment
Time frame: from presentation to delivery
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment
Time frame: from presentation to delivery
Percentage of participants that have unstable housing on completion of syphilis treatment
Time frame: from presentation to delivery
Percentage of participants that have transportation on completion of syphilis treatment
Time frame: from presentation to delivery
Percentage of participants that experience intimate partner violence on completion of syphilis treatment
Time frame: from presentation to delivery
number of prenatal care visits on completion of syphilis treatment
Time frame: from presentation to delivery
Percentage of participants that are married on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have health insurance on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have psychiatric problems on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have unstable housing on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have transportation on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that experience intimate partner violence on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
number of prenatal care visits on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Number of birth parents that have reinfection
Time frame: from presentation to delivery
Number of birth parents that have reinfection
Time frame: at time of postpartum (upto 15 months after delivery)
Number of neonates that have congenital syphilis
Time frame: from presentation to delivery
Number of neonates that have congenital syphilis
Time frame: at time of postpartum (upto 15 months after delivery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irene Stafford, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Point of Care (POC) Syphilis testing in people with Syphilis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Stafford, MD ((713) 500-6412, Irene.Stafford@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis (time frame: within 1 week of presentation until the time of delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.