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?

This trial examines whether a quick test can help detect and treat syphilis and HIV earlier in pregnant patients. It evaluates the effectiveness of the Chembio HIV/Syphilis rapid Point of Care (POC) test alongside standard lab tests in the emergency room. Pregnant individuals visiting the emergency department who have received limited prenatal care or testing for HIV or syphilis during their current pregnancy may qualify for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance early detection and treatment for others.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Chembio HIV/Syphilis rapid POC test is safe for use in pregnancy?

Research has shown that the Chembio HIV/Syphilis rapid test is generally safe to use. For HIV, the test correctly identifies 99.8% of people with the disease and 98.4% of those without it. For syphilis, it correctly identifies 98.8% of people with the disease and 99.4% of those without it. These high numbers indicate that the test is reliable and well-tolerated. Studies have found that testing for both HIV and syphilis simultaneously is cost-effective and helps reduce pregnancy-related issues. Overall, the evidence supports this rapid test as a safe choice for pregnant women.12345

Why are researchers excited about this trial?

Unlike the standard of care for detecting HIV and syphilis during pregnancy, which typically relies on lab-based testing, the Chembio HIV/Syphilis rapid Point of Care (POC) test offers a unique advantage with its quick, on-the-spot results. This rapid test allows for immediate diagnosis, potentially reducing the time to treatment and improving outcomes for both mothers and their babies. Researchers are excited about this test because it simplifies the testing process, making it more accessible and efficient, especially in settings where laboratory resources are limited.

What evidence suggests that the Chembio HIV/Syphilis rapid POC test is effective for detecting infections in pregnancy?

Research has shown that the Chembio HIV/Syphilis rapid Point of Care (POC) test effectively detects HIV and syphilis. One study found that this test correctly identifies HIV 99.8% of the time and syphilis 98.8% of the time, meaning it almost always detects these infections. The test also accurately avoids false positives, rarely indicating an infection when there isn't one. In this trial, participants will receive the Chembio HIV/Syphilis rapid POC test alongside standard lab-based HIV/Syphilis testing. Testing for both HIV and syphilis simultaneously is more cost-effective and helps prevent more pregnancy complications than testing for each separately. Overall, this quick test can serve as a reliable first step in screening pregnant women for these infections.12346

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?

This trial is for pregnant individuals who come to the emergency department or obstetrical triage, have had little or no prenatal care, and haven't been tested for HIV or syphilis during their current pregnancy. Those who are incarcerated, too ill, or decline testing can't participate.

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

Trial Overview

The study compares a rapid point-of-care test that checks for both HIV and syphilis with standard lab-based tests in pregnant patients. It aims to see if using the quick test helps start treatment sooner when infections are found.

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+

Citations

Clinic-based evaluation of point-of-care dual HIV/syphilis ...

A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and ...

Point-of-Care HIV and Syphilis Screening - NCBI Bookshelf

Syphilis screening is recommended in Canada for all pregnant people during the first trimester or at the first prenatal visit.

A systematic review and meta-analysis of studies ...

Dual screening for HIV and syphilis was more cost effective than single rapid tests for HIV and syphilis and prevented more adverse pregnancy outcomes.

Congenital and Maternal Point of Care Rapid Testing for ...

In a study of 570 antenatal women with HIV in Kampala, 5.1% had syphilis. Other Ugandan studies have demonstrated >3% prevalence of antenatal ...

Full article: Use of rapid point-of-care diagnostic tests for ...

Adverse pregnancy outcomes occur in upto 80% of untreated maternal syphilis. National impact targets for elimination include 95% syphilis ...

CHEMBIO RECEIVES A GRANT FOR DEVELOPMENT OF ...

CHEMBIO DIAGNOSTIC SYSTESMS INC., A SUBSIDIARY OF BIOSYNEX, RECEIVES A GRANT FOR DEVELOPMENT OF A RAPID POINT OF CARE TEST FOR PREECLAMPSIA.