HIV InfectionsNCT07525076
Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department
A study testing Chembio HIV/Syphilis rapid Point of Care (POC) test and Laboratory-based HIV and syphilis testing in people with HIV Infections and Syphilis Infection, 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 evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department (ED) testing program and to determine whether dual rapid testing improves early initiation… Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- HIV Infections, Syphilis Infection
- What is being tested?
- Chembio HIV/Syphilis rapid Point of Care (POC) test and Laboratory-based HIV and syphilis testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 31 May 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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnancy
- Presentation to the ED or obstetrical triage during the index pregnancy.
- No established prenatal care (≤1 visit) and/or no documented HIV or syphilis testing during the current pregnancy.
Who cannot join
- Medically unstable or critically ill at the time of ED presentation.
- Incarcerated at the time of ED presentation.
- Decline participation in testing (opt-out) or refuse survey participation.
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Irene Stafford, M.D., M.S., M.P.H., (713) 500-6412, Irene.Stafford@uth.tmc.edu
Robin L Beach, (713) 500-5940, Robin.L.Beach@uth.tmc.edu
About this study
The purpose of this study is to evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department (ED) testing program and to determine whether dual rapid testing improves early initiation of HIV therapy in pregnant patients with newly identified HIV infection.
- Conditions
- HIV Infections, Syphilis Infection
- Being tested
- Chembio HIV/Syphilis rapid Point of Care (POC) test, Laboratory-based HIV and syphilis testing
- Keywords
- Mother-to-child transmission (MTCT), Sexually Transmitted Infections (STI)
- Medical subject headings
- 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 Point of Care (POC) testDiagnostic test
Participants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System.
Laboratory-based HIV and syphilis testingDiagnostic test
Laboratory-based HIV and syphilis testing
| Study group | Role | What they receive |
|---|---|---|
| Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing | Experimental | Not described Receives: Diagnostic Test: Chembio HIV/Syphilis rapid Point of Care (POC) test; Diagnostic Test: Laboratory-based HIV and syphilis testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that tested for HIV
Measured: Baseline
Number of participants that tested for syphilis
Measured: Baseline
Number of participants that tested positive for syphilis and who receive same-visit treatment initiation with Benzathine Penicillin G according to the Centers for Disease Control and Prevention (CDC) 2021 Guidelines.
Measured: about 15 minutes after baseline
Secondary outcomes (1)
Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide)
Measured: about 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 posted13 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Stafford, The University of Texas Health Science Center, Houston
- Investigators
- Irene 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
- NCT07525076
- Sponsor's protocol ID
- HSC-MS-25-0908
- Other IDs
- 5P30AI161943-05
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT07525076
- Acronym / sponsor ID
- HSC-MS-25-0908
- Conditions
- HIV Infections, Syphilis Infection
- Keywords
- Mother-to-child transmission (MTCT), Sexually Transmitted Infections (STI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 13 Apr 2026 (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 evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department (ED) testing program and to determine whether dual rapid testing improves early initiation of HIV therapy in pregnant patients with newly identified HIV infection.
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 plus standard of care lab based HIV/Syphilis testing | Experimental | Diagnostic Test: Chembio HIV/Syphilis rapid Point of Care (POC) test, Diagnostic Test: Laboratory-based HIV and syphilis testing |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnancy
- Presentation to the ED or obstetrical triage during the index pregnancy.
- No established prenatal care (≤1 visit) and/or no documented HIV or syphilis testing during the current pregnancy.
Key exclusion criteria (3 listed)
- Medically unstable or critically ill at the time of ED presentation.
- Incarcerated at the time of ED presentation.
- Decline participation in testing (opt-out) or refuse survey participation.
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 Point of Care (POC) testParticipants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System. | Diagnostic test | Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing |
| Laboratory-based HIV and syphilis testingLaboratory-based HIV and syphilis testing | Diagnostic test | Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing |
Primary outcome
Number of participants that tested for HIV
Time frame: Baseline
Number of participants that tested for syphilis
Time frame: Baseline
Number of participants that tested positive for syphilis and who receive same-visit treatment initiation with Benzathine Penicillin G according to the Centers for Disease Control and Prevention (CDC) 2021 Guidelines.
Time frame: about 15 minutes after baseline
1 secondary outcome
Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide)
Time frame: about 15 minutes after baseline
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 13 Apr 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, 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 Point of Care (POC) test and Laboratory-based HIV and syphilis testing in people with HIV Infections and Syphilis Infection, 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 3 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: opening soon, as of the sponsor's last update on 13 Apr 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, M.D., M.S., M.P.H. ((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?
Number of participants that tested for HIV (time frame: Baseline). The study lists 3 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 13 Apr 2026.