RECRUITING

Modernizing Perinatal Syphilis Testing

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.

Official Title

Modernizing Perinatal Syphilis Testing

Quick Facts

Study Start:2023-05-02
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06082453

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth
  2. * Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis
  1. * Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
  2. * Planning to move outside of study prior to ND testing

Contacts and Locations

Study Contact

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

Principal Investigator

Irene Stafford, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90007
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
Johns Hopkins University
Baltimore, Maryland, 21205
United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Christus Health
Houston, Texas, 78130
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Irene Stafford, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-02
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2023-05-02
Study Completion Date2027-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Syphilis