Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department

April 6, 2026 updated by: Irene Stafford, The University of Texas Health Science Center, Houston
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing
Diagnostic test: Chembio HIV/Syphilis rapid Point of Care (POC) test
Participants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System.
Diagnostic test: Laboratory-based HIV and syphilis testing
Laboratory-based HIV and syphilis testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants that tested for HIV
Time Frame: Baseline
Baseline
Number of participants that tested for syphilis
Time Frame: Baseline
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
about 15 minutes after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide)
Time Frame: about 15 minutes after baseline
about 15 minutes after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Irene Stafford, M.D., M.S., M.P.H., The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-25-0908
  • 5P30AI161943-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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