HIV Infections, Syphilis Infection
Conditions
Keywords
Mother-to-child transmission (MTCT), Sexually Transmitted Infections (STI)
Brief summary
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_TESTChembio 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_TESTLaboratory-based HIV and syphilis testing
Laboratory-based HIV and syphilis testing
Sponsors
The University of Texas Health Science Center, Houston
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants that tested for HIV | Baseline |
| Number of participants that tested for syphilis | 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. | about 15 minutes after baseline |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide) | about 15 minutes after baseline |
Countries
United States
Contacts
CONTACTIrene Stafford, M.D., M.S., M.P.H.
CONTACTRobin L Beach
PRINCIPAL_INVESTIGATORIrene Stafford, M.D., M.S., M.P.H.
The University of Texas Health Science Center, Houston
Outcome results
None listed