Digital Health + Community Support for Pregnancy Complications

(P3OPPY Trial)

Overseen By Rosylen "Roz" Quinney

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-English speakers, Incarcerated, Fetal demise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of pregnancy

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve health outcomes for mothers and infants by testing digital health tools and community health support during pregnancy. It addresses health disparities, particularly among Black and underserved communities, by providing resources beyond routine prenatal care. Participants will be divided into groups to receive digital health interventions, community health worker support (CHW), both, or just the usual care. This trial suits non-Hispanic Black individuals who are pregnant and planning to deliver at UAB Hospital. As an unphased trial, it offers participants the chance to contribute to innovative research that could shape future prenatal care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital health tools are generally safe and can help manage high-risk pregnancies. These tools detect issues early and offer real-time monitoring and personalized care for mothers and babies. They are well-accepted, with no specific safety concerns reported.

Community health worker (CHW) programs also improve health outcomes for mothers. Studies have shown they reduce stress and lead to better birth outcomes, such as fewer preterm births. CHWs effectively reach underserved communities and provide quality care without safety issues.

Combining digital health tools with CHWs might enhance these benefits. Although specific safety data for this combination is limited, each approach alone is safe. Participants in these programs usually experience better outcomes and find the interventions helpful. Overall, both treatments are safe and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches to supporting expectant mothers facing pregnancy complications. Unlike standard prenatal care, the trial combines digital health interventions and community health worker (CHW) support. The digital health intervention is tailored to be easily understood at a 7th-grade reading level, ensuring accessibility for all participants. Meanwhile, the CHW approach offers personalized, non-clinical support based on a successful program in Jefferson County, Alabama. By blending technology with human support, this trial aims to enhance prenatal care and improve outcomes for mothers and babies.

What evidence suggests that this trial's treatments could be effective for improving maternal and infant health outcomes?

This trial will compare the effectiveness of different interventions for improving pregnancy outcomes. Participants in one arm will receive a Digital Health Intervention (DHI), which studies have shown can significantly improve pregnancy outcomes by lowering high blood pressure during pregnancy and reducing the risk of early birth and miscarriage. Another arm will involve Community Health Workers (CHWs), who have improved pregnancy outcomes, particularly for Black women, by reducing the chances of early births. A third arm will combine both DHI and CHW interventions, as research indicates that digital tools paired with community support can enhance prenatal care quality and improve overall maternal health. These tools provide real-time monitoring and personalized care, making them promising options for improving pregnancy outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Wally Carlo, MD

Principal Investigator

University of Alabama at Birmingham

Rachel Sinkey, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

The POPPY trial is for non-Hispanic Black individuals experiencing pregnancy complications. It aims to support maternal/infant health, focusing on those facing healthcare inequities. Participants should be dealing with pregnancy issues and willing to engage with digital and community-based interventions.

Inclusion Criteria

I am between 16 and 49 years old.

Live singleton or dichorionic twin gestation

Dating sonogram at <23 weeks gestation

Exclusion Criteria

I choose not to be randomly assigned to a treatment group.

Speaks or writes in languages other than English

Participated in POPPY Pilot

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine prenatal care services and are randomized to receive either Digital Health Intervention, Community Health Worker intervention, both, or usual care

Duration of pregnancy

Regular prenatal visits

Postpartum Follow-up

Participants are monitored for maternal and neonatal outcomes, including adverse events and postpartum care

6 weeks postpartum

Outpatient visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker
• Digital Health Intervention

Trial Overview

This study tests if a combination of digital health tools and community health worker support can improve pregnancy outcomes compared to each intervention alone. The goal is to see which method better reduces complications during pregnancy in underserved populations.

How Is the Trial Designed?

Group I: Digital Health Intervention (DHI) Experimental Treatment 1 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 CHW Experimental Treatment 1 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 Treatment 1 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 12 weeks postpartum. The intervention has been modified by the POPPY Study Team and Community Advisory Board

Group IV: Usual Care Active Control 1 Intervention

This group will receive routine prenatal care services.

Community Health Worker is already approved in United States for the following indications:

Approved in United States as Community Health Worker for:

• Support for diabetes technology use in type 1 diabetes

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Memora Health

Collaborator

Trials

2

Recruited

440+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

ConnectionHealth

Collaborator

Trials

2

Recruited

440+

Published Research Related to This Trial

The health video library (HVL) intervention was found to be acceptable and feasible for community health workers (CHWs) in Afghanistan, enhancing their ability to promote reproductive, maternal, neonatal, and child health (RMNCH) care while increasing their professional credibility.

CHWs reported that the HVL improved time efficiency and reduced their workload, although challenges such as inconsistent electricity access for charging tablets and gender-related barriers to reaching all households need to be addressed for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a health video library for use in Afghanistan: provider-level acceptability and lessons for strengthening operational feasibility. Lorenzetti, L., Tharaldson, J., Pradhan, S., et al.[2021]

Community health workers (CHWs) foster trust-based relationships with perinatal women, which significantly enhance their prenatal care experience and health outcomes, as reported by 39 clients in focus groups and interviews.

These relationships provide essential emotional, informational, and instrumental support, leading to improved engagement with healthcare, better health behaviors, and reduced stress, highlighting the importance of trust-building in community health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features and Impact of Trust-Based Relationships Between Community Health Workers and Low-Resource Perinatal Women with Chronic Health Conditions. Boyd, LM., Mehra, R., Thomas, J., et al.[2021]

Community health workers (CHWs) face significant challenges in gaining trust from mothers and infants during home visits, primarily due to concerns about confidentiality and professionalism, as highlighted in a qualitative study involving 19 focus group discussions in rural KwaZulu-Natal, South Africa.

Support from professional nurses is essential for CHWs to establish credibility; if clinic staff question a CHW's abilities, it can severely damage the trust community members have in them, indicating the need for better training and supervision for CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trust of community health workers influences the acceptance of community-based maternal and child health services. Grant, M., Wilford, A., Haskins, L., et al.[2022]

Community health worker (CHW) interventions, particularly those involving home visits and women's groups, can improve equitable access to maternal and newborn health services in low-income and middle-income countries, as shown in a review of 22 studies.

While some CHW interventions have successfully reduced health inequities, others have not, indicating that the effectiveness of these programs can vary based on the type of intervention and the support provided to CHWs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. Blanchard, AK., Prost, A., Houweling, TAJ.[2022]

Community health worker (CHW) interventions have been shown to improve knowledge related to pregnancy and infant health, as well as increase the receipt of antenatal care, with 10 out of 123 studies indicating positive outcomes.

CHWs, who are often local community members, play a crucial role in health education and home visits, and their effectiveness is enhanced when they collaborate with clinical providers to improve maternal and child health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Impact on Knowledge, Antenatal Care, And Birth Outcomes: A Systematic Review. Scharff, D., Enard, KR., Tao, D., et al.[2022]

Smart mobile devices can enhance the effectiveness of community health workers (CHWs) by improving their knowledge, motivation, and the credibility of their health messages, as shown in a review of 12 studies, mostly using qualitative methods.

However, while these devices can stimulate interest and engagement, they may also lead to challenges such as reduced quality of interactions if CHWs rely too much on passive content consumption, highlighting the need for adequate training and further research on client behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Use of Smart Devices for Health Promotion: Scoping Review. Greuel, M., Sy, F., Bärnighausen, T., et al.[2023]

Community Health Workers (CHWs) who received enhanced training and support were 15% more likely to fully immunize their clients and 14% more likely to ensure that clients completed four or more antenatal care visits, indicating the effectiveness of the intervention in improving health outcomes.

The study found that recent training and experience with pregnant women significantly increased CHW knowledge, while education and literacy showed mixed associations with competency, suggesting that these factors may not be the best criteria for selecting CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. Rogers, A., Goore, LL., Wamae, J., et al.[2023]

The implementation of a mobile health (mHealth) refresher training program for community health workers (CHWs) in Mukono, Uganda, successfully utilized low-cost tablets to enhance training on childhood pneumonia, allowing CHWs to learn at their own pace and conduct community outreach effectively.

Key success factors included strong local leadership and stakeholder engagement, while challenges highlighted the need for tailored digital literacy training and careful planning of the implementation timeline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of low-cost ruggedized Android tablets to augment in-service training of community health workers in Mukono, Uganda: perspectives and lessons learned from the field. Stiles, CE., O'Neil, E., Kabali, K., et al.[2022]

Scaling up community health worker (CHW) programs to deliver 30 evidence-based interventions could prevent up to 6.9 million maternal, neonatal, and child deaths between 2016 and 2020, especially benefiting the Africa Region which would account for 58% of lives saved at 90% coverage.

Key interventions that would have the greatest impact include nutritional support during pregnancy, malaria treatment with artemisinin, oral rehydration for diarrhea, hand washing, and antibiotics for pneumonia, highlighting the importance of these strategies in reducing preventable deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding the population coverage of evidence-based interventions with community health workers to save the lives of mothers and children: an analysis of potential global impact using the Lives Saved Tool (LiST). Chou, VB., Friberg, IK., Christian, M., et al.[2022]

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This study aims to analyze multiple types of CHWs and their impact on a broad range of antenatal and infant health outcomes across India.

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