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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Chembio HIV/Syphilis rapid Point of Care (POC) test
Diagnostic testParticipants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System.
Laboratory-based HIV and syphilis testing
Diagnostic testLaboratory-based HIV and syphilis testing
Treatment groups
Trial outcomes
Primary outcomes
Number of participants that tested for HIV
Number of participants that tested for syphilis
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.
Secondary outcomes
Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide)
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: