RECRUITING

Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial

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 PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.

Official Title

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial

Quick Facts

Study Start:2024-08-01
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06510075

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:16 Years to 49 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self Identifies as Non-Hispanic Black
  2. * Between 16-49 years old
  3. * Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
  4. * Live singleton or dichorionic twin gestation
  5. * Dating sonogram at \<23 weeks gestation,
  6. * Area Deprivation Index (ADI) National 4th or 5th Quintile
  7. * Planning to deliver at UAB Hospital
  8. * Speaks and writes in English
  9. * No indication for delivery at the time of enrollment
  1. * Declines randomization
  2. * Speaks or writes in languages other than English
  3. * Currently incarcerated
  4. * Fetal demise diagnosed prior to enrollment
  5. * Known major structural chromosomal abnormalities prior to enrollment
  6. * Participated in POPPY Pilot

Contacts and Locations

Study Contact

Rosylen "Roz" Quinney
CONTACT
205.934.1309
rquinney@uabmc.edu

Principal Investigator

Rachel Sinkey, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Wally Carlo, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Rachel Sinkey, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham
  • Wally Carlo, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2024-08-01
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy outcomes
  • Health inequities

Additional Relevant MeSH Terms

  • Pregnancy Complications
  • Maternal Distress
  • Adverse Birth Outcomes
  • Infant Conditions