Rapid Testing for Sexually Transmitted Infections in Pregnancy

IS
RL
Overseen ByRobin L Beach
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

IS

Irene Stafford, M.D., M.S., M.P.H.

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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

Incarcerated at the time of ED presentation
I do not want to take part in testing or surveys.
I am not medically unstable or critically ill right now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Implementation of the Chembio DPP® HIV-Syphilis rapid POC test and standard lab-based testing

Immediate
1 visit (in-person)

Treatment Initiation

Early initiation of HIV therapy for pregnant patients with newly identified HIV infection

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment initiation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Chembio HIV/Syphilis rapid Point of Care (POC) test

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testingExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+