NCT07525076

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
26mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

HIV InfectionsSyphilis Infection

Keywords

Mother-to-child transmission (MTCT)Sexually Transmitted Infections (STI)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide)

    about 15 minutes after baseline

Study Arms (1)

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

EXPERIMENTAL
Diagnostic Test: Chembio HIV/Syphilis rapid Point of Care (POC) testDiagnostic Test: Laboratory-based HIV and syphilis testing

Interventions

Chembio HIV/Syphilis rapid Point of Care (POC) testDIAGNOSTIC_TEST

Participants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System.

Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing
Laboratory-based HIV and syphilis testingDIAGNOSTIC_TEST

Laboratory-based HIV and syphilis testing

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

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Interventions

Syphilis Serodiagnosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serologic TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

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

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(713) 500-6412Irene.Stafford@uth.tmc.edu

Robin L Beach

CONTACT

(713) 500-5940Robin.L.Beach@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)