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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07525076
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
1,400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing

Primary Outcome Measure

Number of participants that tested for HIV [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Irene Stafford, M.D., M.S., M.P.H.
[email protected]
(713) 500-6412
Robin L Beach
[email protected]
(713) 500-5940

Find similar trials in Houston, TX

By condition
HIV
By specialty
Infectious disease
By research site
The University of Texas Health Science Center at Houston· Houston, TX

Related Studies