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RECRUITING NA

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

NCT06510075 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BEHAVIORAL Community Health Worker
  • BEHAVIORAL Digital Health intervention
  • BEHAVIORAL Digital Health Intervention plus Community Health Worker

Study Locations (1)

Alabama

  • University of Alabama at Birmingham — Birmingham

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2024-08-01
Est. Completion 2027-01-31
Phase NA

Sponsor

University of Alabama at Birmingham

1,315 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06510075

The ClinicalTrials.gov registry entry for NCT06510075 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Pregnancy Complications appearing as the primary indexed condition, and to 3 interventions — of which Community Health Worker is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06510075 reports 1 study location spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06510075 about?

NCT06510075 is a clinical study titled "Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial". 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 ...

What is the current status of trial NCT06510075?

This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-08-01. Estimated completion is 2027-01-31.

What conditions does trial NCT06510075 study?

This clinical trial studies the following conditions: Pregnancy Complications, Maternal Distress, Infant Conditions, Adverse Birth Outcomes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06510075?

The interventions under investigation include: Community Health Worker (BEHAVIORAL), Digital Health intervention (BEHAVIORAL), Digital Health Intervention plus Community Health Worker (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06510075?

This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06510075 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial