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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-45
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

1,400 Participants
are divided into 1 treatment group
Group A: Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testingExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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The University of Texas Health Science Center, Houston

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: