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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment?

Research shows that community health worker (CHW) programs can improve maternal and child health outcomes, especially in low-resource settings. CHWs have been effective in increasing knowledge about pregnancy and infant health, improving access to antenatal care, and reducing infant and neonatal mortality. ^{1 2 3 4 5}

Is the combination of digital health and community support safe for pregnancy complications?

Community health worker (CHW) programs, which often include digital health tools, are generally considered safe and have been used effectively to support maternal and child health in various settings. While specific safety data for pregnancy complications is not detailed, CHWs have been trusted to provide community-based health services without significant safety concerns. ^{1 3 6 7 8}

How is the Digital Health + Community Support treatment for pregnancy complications different from other treatments?

This treatment is unique because it combines the support of community health workers (CHWs) with digital health tools, like smartphones or tablets, to improve pregnancy outcomes. CHWs provide personalized support and education, while digital tools help them stay updated and connected, making it a more accessible and supportive approach compared to traditional methods. ^{1 2 3 6 9}

What is the purpose of this 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 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.

Research Team

Wally Carlo, MD

Principal Investigator

University of Alabama at Birmingham

Rachel Sinkey, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Speaks or writes in languages other than English

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

Participated in POPPY Pilot

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Community Health Worker Impact on Knowledge, Antenatal Care, And Birth Outcomes: A Systematic Review. [2022]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Adapting a health video library for use in Afghanistan: provider-level acceptability and lessons for strengthening operational feasibility. [2021]

5. Scotland 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). [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Community Health Worker Use of Smart Devices for Health Promotion: Scoping Review. [2023]

7. Switzerland 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. [2023]

8. South Africa pubmed.ncbi.nlm.nih.gov

Trust of community health workers influences the acceptance of community-based maternal and child health services. [2022]

9. Uganda 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. [2022]