SyphilisNCT07498153
Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting
A study testing Chembio HIV/Syphilis rapid POC test in people with Syphilis and HIV Infections, 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 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… Read more about this study
- Who is it for?
- Ages 14 to 65 years, women only
- Conditions the study is for
- Syphilis, HIV Infections
- What is being tested?
- Chembio HIV/Syphilis rapid POC test
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 2 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants not at clinical sites in Puerto Barrios, Guatemala between 09/27/2025 and 10/03/2025
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
- Being tested
- Chembio HIV/Syphilis rapid POC test
- Keywords
- Mother-to-child transmission (MTCT), Sexually Transmitted Infections (STI)
- Medical subject headings
- Syphilis, HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chembio HIV/Syphilis rapid POC testDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Chembio HIV/Syphilis rapid POC test | Experimental | Not described Receives: Device: Chembio HIV/Syphilis rapid POC test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Completed Screening
Measured: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis
Measured: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for HIV
Measured: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis and HIV
Measured: end of study (15 minutes after baseline)
Number of Participants That Received Treatment
Measured: end of study (15 minutes after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Sep 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
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 A Stafford, M.D., M.S., M.P.H, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498153
- Sponsor's protocol ID
- HSC-MS-25-0430
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting
- ClinicalTrials.gov ID
- NCT07498153
- Acronym / sponsor ID
- HSC-MS-25-0430
- Conditions
- Syphilis, HIV Infections
- Keywords
- Mother-to-child transmission (MTCT), Sexually Transmitted Infections (STI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Posted 28 Aug 2026
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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chembio HIV/Syphilis rapid POC test | Experimental | Device: Chembio HIV/Syphilis rapid POC test |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Participants not at clinical sites in Puerto Barrios, Guatemala between 09/27/2025 and 10/03/2025
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 |
|---|---|---|
| Chembio HIV/Syphilis rapid POC testParticipants 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 | Device | Chembio HIV/Syphilis rapid POC test |
Primary outcome
Number of Participants That Completed Screening
Time frame: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis
Time frame: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for HIV
Time frame: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis and HIV
Time frame: end of study (15 minutes after baseline)
Number of Participants That Received Treatment
Time frame: end of study (15 minutes after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Syphilis
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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. This study is not recruiting at the moment.
Irene A Stafford, M.D., M.S., M.P.H 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 Chembio HIV/Syphilis rapid POC test in people with Syphilis and HIV Infections, 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 2 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: finished, as of the sponsor's last update on 28 Aug 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?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Completed Screening (time frame: end of study (15 minutes after baseline)). The study lists 5 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 28 Aug 2026.