NCT06510075 · University of Alabama at Birmingham
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
(P3OPPY)
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2025 · Source of record for eligibility and locations