Recruiting

POPPY

Sponsor:

University of Alabama at Birmingham

Code:

NCT06510075

Conditions

Pregnancy Complications

Maternal Distress

Adverse Birth Outcomes

Infant Conditions

Eligibility Criteria

Sex: Female

Age: 16 - 49

Healthy Volunteers: Not accepted

Interventions

Digital Health intervention

Community Health Worker

Digital Health Intervention plus Community Health Worker

Study Details

Brief summary:

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.

Conditions

Pregnancy Complications

Maternal Distress

Adverse Birth Outcomes

Infant Conditions

Study ID

NCT06510075

Start date

Aug 1, 2024

Status verified date

Jul, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 49

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Self Identifies as Non-Hispanic Black
  • Between 16-49 years old
  • Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
  • Live singleton or dichorionic twin gestation
  • Dating sonogram at <23 weeks gestation,
  • Area Deprivation Index (ADI) National 4th or 5th Quintile
  • Planning to deliver at UAB Hospital
  • Speaks and writes in English
  • No indication for delivery at the time of enrollment

Exclusion Criteria:

  • Declines randomization
  • Speaks or writes in languages other than English
  • Currently incarcerated
  • Fetal demise diagnosed prior to enrollment
  • Known major structural chromosomal abnormalities prior to enrollment
  • Participated in POPPY Pilot

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Digital Health Intervention (DHI)

This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.

experimental: Community health worker (CHW)

Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through 12 weeks postpartum. The intervention has been modified by the POPPY Study Team and Community Advisory Board

experimental: DHI Plus CHW

This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.

no intervention: Usual Care

This group will receive routine prenatal care services.

Interventions

Digital Health intervention

Health care information delivered via a link in a text message that is then opened in a secure browser.

Community Health Worker

Health care information delivered via CHW.

Digital Health Intervention plus Community Health Worker

Health care information delivered via DHI plus CHW

Primary outcome measure

  • Weighted Adverse Outcome Score (WAOS) [ Time Frame: [Time Frame: From randomization to 6 weeks postpartum] ]

Central Contacts and Locations

Central contacts

Rosylen "Roz" Quinney

205.934.1309rquinney@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Rosylen Quinney

205.934.1309rquinney@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Pregnancy outcomes
  • Health inequities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-23.