PregnancyPᵌOPPYNCT05940688
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
A study testing Digital Health intervention, Community Health Worker and Digital Health Intervention plus Community Health Worker in people with Pregnancy and Infants, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Pregnancy, Infants, Disparities
- What is being tested?
- Digital Health intervention, Community Health Worker and Digital Health Intervention plus Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Planning to deliver at UAB Hospital
- Speaks and writes in English
- No indication for delivery at the time of enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the detailed description
Feasibility Study Aims
- To assess the feasibility of the digital health (DHI) and community health worker (CHW) interventions by assessing participant acceptance and use of the intervention.
- To assess study enrollment to determine appropriateness and usefulness of the inclusion and exclusion criteria to estimate enrollment duration in the planned trial.
- To determine the number of prenatal visits and the incidence of some of the maternal and neonatal outcomes (ones with higher prevalence) or surrogate outcomes that will be targeted in the planned factorial design randomized controlled trial. (Data will be collected on all relevant maternal and neonatal outcomes. The randomized feasibility design will allow for effect size estimates of the intervention on the incidence of maternal and neonatal outcomes, which will aid in determining the appropriate target outcomes as well as power calculation of the more definitive 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 promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond. The objective of this pilot study is to determine if it is feasible to randomize and implement digital health and community health worker interventions.
Design Summary
The investigators will challenge existing care paradigms by testing the effectiveness of integrating innovative platforms into the existing healthcare system, including existing digital health and community health worker programs from within the EQUATE consortium, to eliminate critical barriers to equitable healthcare access. After seeking input from a Community Advisory Board, these interventions will be refined and deployed for pilot testing. Individuals in Non-Hispanic Black communities at the highest risk of adverse pregnancy outcomes which were historically underrepresented in clinical research due to structural racism will be included. The investigative team employs experts across the community, maternal, and infant health continuum.
For this pilot, 40 eligible participants will be randomized, 10 to usual care, 10 to DHI, 10 to CHW, and 10 to DHI + CHW
- Conditions
- Pregnancy, Infants, Disparities
- Being tested
- Digital Health intervention, Community Health Worker, Digital Health Intervention plus Community Health Worker
- Keywords
- Pregnancy outcomes, Health inequities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health interventionBehavioural
Also called DHI
Health care information delivered via a link in a text message that is then opened in a secure browser.
Community Health WorkerBehavioural
Also called CHW
Health care information delivered via CHW.
Digital Health Intervention plus Community Health WorkerBehavioural
Health care information delivered via DHI plus CHW
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Intervention | Experimental | 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. Receives: Behavioral: Digital Health intervention |
| Community health worker (CHW) | Experimental | 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. Receives: Behavioral: Community Health Worker |
| DHI Plus CHW | Experimental | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. Receives: Behavioral: Digital Health Intervention plus Community Health Worker |
| Usual Care | No intervention | This group will receive routine prenatal care services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Acceptance of Randomization Arm / Intervention
Participant acceptance is defined as a yes response to this question:
"I would recommend the care I received to someone in a similar situation."
Measured: 6 weeks postpartum
Participant Use of Digital Health and/or Community Health Worker Interventions
Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker.
Measured: From randomization to 6 weeks postpartum
Secondary outcomes (9)
Outpatient Perinatal Care Visits
Number of perinatal care visits
Measured: Randomization to study completion (up to 34 weeks)
Preterm Birth
Delivery of a neonate at less than 37 weeks
Measured: At birth
Neonatal Birthweight
Weight of neonate at birth
Measured: At birth
Cesarean Delivery
Occurrence of a cesarean birth
Measured: At birth
Maternal Blood Transfusion
Transfusion of blood products
Measured: At birth
Breastfeeding Intent
Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization
Measured: Upon admission to the delivery-associated hospitalization
Vaccination Rate
The number of mothers who received Tdap and infants who received the Hep B vaccine.
Measured: Pregnancy through 6 weeks postpartum / 6 weeks of life
Maternal Postpartum Readmission
Admission of the mother to the hospital after discharge from the delivery-associated hospitalization
Measured: From discharge from the delivery-associated hospitalization to 6 weeks postpartum
Neonatal Hospital Readmission
Answer to the question " How is your baby doing?"
Measured: Birth to 6 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start17 Jul 2023
- Primary completion30 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study is a pilot randomized trial (n=40) randomizing eligible participants to usual care (n=10), or usual care plus a digital health intervention (n=10), or usual care plus a community health worker intervention (n=10), or usual care plus both a digital health intervention and a community health worker intervention.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, ConnectionHealth, Memora Health
- Responsible party
- Principal investigator, Rachel Sinkey, University of Alabama at Birmingham
- Investigators
- Rachel Sinkey, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940688
- Sponsor's protocol ID
- 300009897
- Other IDs
- 22HERNPMI985239
- Acronym
- PᵌOPPY
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2023
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
- ClinicalTrials.gov ID
- NCT05940688
- Acronym / sponsor ID
- PᵌOPPY / 300009897
- Conditions
- Pregnancy, Infants, Disparities
- Keywords
- Pregnancy outcomes, Health inequities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Heart Association, ConnectionHealth, Memora Health
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Feasibility Study Aims
- To assess the feasibility of the digital health (DHI) and community health worker (CHW) interventions by assessing participant acceptance and use of the intervention.
- To assess study enrollment to determine appropriateness and usefulness of the inclusion and exclusion criteria to estimate enrollment duration in the planned trial.
- To determine the number of prenatal visits and the incidence of some of the maternal and neonatal outcomes (ones with higher prevalence) or surrogate outcomes that will be targeted in the planned factorial design randomized controlled trial. (Data will be collected on all relevant maternal and neonatal outcomes. The randomized feasibility design will allow for effect size estimates of the intervention on the incidence of maternal and neonatal outcomes, which will aid in determining the appropriate target outcomes as well as power calculation of the more definitive 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 promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond. The objective of this pilot study is to determine if it is feasible to randomize and implement digital health and community health worker interventions.
Design Summary
The investigators will challenge existing care paradigms by testing the effectiveness of integrating innovative platforms into the existing healthcare system, including existing digital health and community health worker programs from within the EQUATE consortium, to eliminate critical barriers to equitable healthcare access. After seeking input from a Community Advisory Board, these interventions will be refined and deployed for pilot testing. Individuals in Non-Hispanic Black communities at the highest risk of adverse pregnancy outcomes which were historically underrepresented in clinical research due to structural racism will be included. The investigative team employs experts across the community, maternal, and infant health continuum.
For this pilot, 40 eligible participants will be randomized, 10 to usual care, 10 to DHI, 10 to CHW, and 10 to DHI + CHW
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- Study is a pilot randomized trial (n=40) randomizing eligible participants to usual care (n=10), or usual care plus a digital health intervention (n=10), or usual care plus a community health worker intervention (n=10), or usual care plus both a digital health intervention and a community health worker intervention.
| Arm | Type | Receives |
|---|---|---|
| Digital Health Intervention | Experimental | Behavioral: Digital Health interventionThis 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. |
| Community health worker (CHW) | Experimental | Behavioral: Community Health WorkerIndividuals 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. |
| DHI Plus CHW | Experimental | Behavioral: Digital Health Intervention plus Community Health WorkerThis group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. |
| Usual Care | No intervention | –This group will receive routine prenatal care services. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health interventionAlso: DHIHealth care information delivered via a link in a text message that is then opened in a secure browser. | Behavioural | Digital Health Intervention |
| Community Health WorkerAlso: CHWHealth care information delivered via CHW. | Behavioural | Community health worker (CHW) |
| Digital Health Intervention plus Community Health WorkerHealth care information delivered via DHI plus CHW | Behavioural | DHI Plus CHW |
Primary outcome
Participant Acceptance of Randomization Arm / Intervention
Time frame: 6 weeks postpartum
Participant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation."
Participant Use of Digital Health and/or Community Health Worker Interventions
Time frame: From randomization to 6 weeks postpartum
Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker.
9 secondary outcomes
Outpatient Perinatal Care Visits
Time frame: Randomization to study completion (up to 34 weeks)
Preterm Birth
Time frame: At birth
Neonatal Birthweight
Time frame: At birth
Cesarean Delivery
Time frame: At birth
Maternal Blood Transfusion
Time frame: At birth
Breastfeeding Intent
Time frame: Upon admission to the delivery-associated hospitalization
Vaccination Rate
Time frame: Pregnancy through 6 weeks postpartum / 6 weeks of life
Maternal Postpartum Readmission
Time frame: From discharge from the delivery-associated hospitalization to 6 weeks postpartum
Neonatal Hospital Readmission
Time frame: Birth to 6 weeks of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Sinkey, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health intervention, Community Health Worker and Digital Health Intervention plus Community Health Worker in people with Pregnancy and Infants, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Acceptance of Randomization Arm / Intervention (time frame: 6 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.