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Not yet recruiting NCT07525076

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

No phase Interventional HIV Infections Syphilis Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chembio HIV/Syphilis rapid Point of Care (POC) test, Laboratory-based HIV and syphilis testing.
Who it may be relevant to
Registry conditions: HIV Infections, Syphilis Infection. Basic parameters: 14 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide) [Time frame: about 15 minutes after baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07525076 · HSC-MS-25-0908 · 5P30AI161943-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗