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NCT Number: NCT07525076

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Syphilis Infection Urogenital Diseases Virus Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chembio HIV/Syphilis rapid Point of Care (POC) test

Diagnostic Test

Participants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System.

Laboratory-based HIV and syphilis testing

Diagnostic Test

Laboratory-based HIV and syphilis testing

Primary outcomes

  1. Number of participants that tested for HIV

    Time frame: Baseline

  2. Number of participants that tested for syphilis

    Time frame: Baseline

  3. 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

Secondary outcomes

  1. Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide)

    Time frame: about 15 minutes after baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Stafford, M.D., M.S., M.P.H.

CONTACT

[email protected]

(713) 500-6412

Robin L Beach

CONTACT

[email protected]

(713) 500-5940

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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