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Behavioral Intervention

Digital Health + Community Support for Pregnancy Inequality (PᵌOPPY Trial)

N/A
Recruiting
Led By Rachel Sinkey, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pregnancy through 6 weeks postpartum / 6 weeks of life
Awards & highlights

PᵌOPPY Trial Summary

This trial seeks to reduce racism & social problems that contribute to poor health outcomes for Black & under-served populations during & after pregnancy. #EquityinMaternalandInfantHealth

Who is the study for?
The P3OPPY study is for non-Hispanic Black pregnant individuals aged 16-49, in early to mid-pregnancy (8-22 weeks), living in areas with higher deprivation. They must plan to deliver at UAB Hospital, speak and write English, and not be facing immediate delivery or have known fetal abnormalities.Check my eligibility
What is being tested?
This trial tests the effectiveness of a digital health intervention alone or combined with a community health worker's support. It aims to improve pregnancy outcomes by addressing healthcare access and social inequalities among Black and underserved populations.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like digital tools and community support, traditional side effects are not expected. However, participants may experience issues related to technology use or interactions with the health workers.

PᵌOPPY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and at birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant acceptance of randomization arm / intervention
Participant use of digital health and/or community health worker interventions
Secondary outcome measures
Breastfeeding intent
Cesarean delivery
Maternal blood transfusion
+6 more

PᵌOPPY Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Digital Health InterventionExperimental Treatment1 Intervention
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.
Group II: DHI Plus CHWExperimental Treatment1 Intervention
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
Group III: Community health worker (CHW)Experimental Treatment1 Intervention
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 their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
Group IV: Usual CareActive Control1 Intervention
This group will receive routine prenatal care services.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Community Health Worker
2017
Completed Phase 3
~2110

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,442 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,586 Total Patients Enrolled
ConnectionHealthUNKNOWN

Media Library

Community Health Worker (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05940688 — N/A
Pregnancy Research Study Groups: Community health worker (CHW), Digital Health Intervention, DHI Plus CHW, Usual Care
Pregnancy Clinical Trial 2023: Community Health Worker Highlights & Side Effects. Trial Name: NCT05940688 — N/A
Community Health Worker (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05940688 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of this experiment confined to adults aged 18 and over?

"According to the prerequisites for participation in this research undertaking, individuals must be between 16 and 49 years old."

Answered by AI

Is this clinical experiment presently open to participants?

"As evidenced on clinicaltrials.gov, this particular medical trial is no longer recruiting participants. It was originally posted on July 5th 2023 and the last edit occurred two days before that date. In spite of this, there are still 95 other trials actively taking patients at present."

Answered by AI

What goals does this clinical trial endeavor to accomplish?

"This trial is assessing Participant acceptance of randomization arm / intervention over a six week period post-randomisation. Secondary metrics include Preterm Birth, Neonatal birthweight, and Cesarean delivery."

Answered by AI

Do I meet the requirements to partake in this medical experiment?

"To be eligible to join this medical study, applicants must have conceived within the past 16-49 years and 40 people are being sought."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
Rachel Sinkey 2023. "Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05940688.
~7 spots leftby Jun 2024
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