RECRUITING

Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity

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

Severe Maternal Morbidity (SMM) has been associated with maternal mortality, fetal risk, and long-term maternal risk. African American (AA) women are at consistently higher risk than White women. However, factors contributing to these racial disparities are largely unknown and commonly known factors have not been able to explain them, so strategies to reduce them are absent. CDC reports that the rate of GHSV infection is 4 times higher in AA than White women. Studies have shown that pregnant women with genital herpes simplex virus (GHSV) infection are at higher risk of SMM and that treating women with GHSV using existing anti-herpes medications could reduce SMM risk. To address the question of racial disparities in SMM and examine the comparative effectiveness of treating women with GHSV infection to reduce the risk of SMM, the investigators are conducting a large cohort study with a two-stage design, combining an EMR-based cohort (Stage I) with a sub-cohort interview (Stage II) to examine the impact of confounders not available from EMR data. Based on status of GHSV and treatment, 4 cohorts of women will be established: (1) those with GHSV infection receiving treatment early in pregnancy; (2) those with GHSV infection receiving treatment later in pregnancy; (3) those with GHSV infection untreated during pregnancy; and (4) those without GHSV. Given that racial disparities in SMM present serious challenges, the study will provide much needed data to address the effectiveness of treating GHSV on reducing racial disparities in SMM.

Official Title

Comparative Effectiveness of Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity (SMM)

Quick Facts

Study Start:2023-01-08
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05429346

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:18 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Kaiser Permanente Northern California Members
  2. * Pregnant women
  1. * Non Kaiser Permanente Northern California Members
  2. * Non-pregnant women

Contacts and Locations

Study Contact

Roxana Odouli, MSPH
CONTACT
888.381.6818
Roxana.Odouli@kp.org
Sannaz Keyhani, MA
CONTACT
510.326.0174
Sannaz.Keyhani@kp.org

Principal Investigator

De-Kun Li, MD, PhD
PRINCIPAL_INVESTIGATOR
Division of Research, Kaiser Permanente Northern California

Study Locations (Sites)

Division of Research, Kaiser Permanente Northern California
Oakland, California, 94312
United States

Collaborators and Investigators

Sponsor: Kaiser Permanente

  • De-Kun Li, MD, PhD, PRINCIPAL_INVESTIGATOR, Division of Research, Kaiser Permanente Northern California

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 Date2023-01-08
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-01-08
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • GHSV
  • SMM
  • Racial Disparities

Additional Relevant MeSH Terms

  • Genital Herpes Simplex
  • Maternal Morbidity
  • Racial Disparities