Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
Phase: NA
Conditions: Pregnancy, Infants, Disparities
Sponsor: University of Alabama at Birmingham

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___________________________________________________________ 
 
 
Providing an Optimized and empowered Pregnancy for You (PᵌOPPY) 
 
Aim 2: Pilot 
 
 
______________________________ ____________________________ 
___________________________________________________________ 
 
Protocol v2.0 
_____________________________________________________________________________________ 
___________________________________________________________ 
 
 
 
Funded by the American Heart Association HERN 300009897 through the  
 
P3 EQUATE Network 
 
 
 
 
Prepared by the Center for Women’s Reproductive Health 
 
Department of Obstetrics & Gynecology 
 
University of Alabama at Birmingham Heersink School of Medicine  
 
 
 
 

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Table of Contents  
 
1. INTRODUCTION 
1. 
Study Abstract 
2. 
Primary Hypotheses  
3. 
Purpose of the Study Protocol 
2. BACKGROUND 
3. PRELIMINARY DATA FROM AIM1 
4. STUDY DESIGN 
1. 
Primary Research Question / Hypothesis 
2. 
Secondary Research Questions / Hypotheses 
3. 
Design Summary 
4. 
Eligibility Criteria 
5. 
Informed Consent  
5. STUDY PROCEDURES 
1. 
Overview 
2. 
Locating, Contacting and Screening Participants 
3. 
Procedures to Obtain Informed Consent 
4. 
   Virtual Visits  
i. Interval history and outcomes 
ii. Questionnaires 
iii. Community Health Workers 
iv. Digital Health Intervention 
5. 
In-Person Visit  
i. Interval History and Outcomes 
ii. Standardized Assessments and Questionnaires 
iii. Community Health Workers 
6. 
Adverse Event Reporting 
7. 
ADAPT-ITT   
8. 
Pre-Pilot Testing 
6. SAMPLE SIZE AND POWER 
7. DATA COLLECTION 
1. 
Data Collection Forms 
2. 
Web Data Entry and Management 
3. 
Performance Monitoring 
8. STUDY ADMINISTRATION 
1. 
Organization and Funding 
2. 
Committees 
i. Steering Committee  
ii. Protocol Subcommittee 
iii. Publications Subcommittee  
9. STUDY TIMETABLE 
1. 
Training and Certification 
2. 
Study Timeline 
3. 
Recruitment and Data Collection Period 
4. 
Final Analysis 
10. REFERENCES 
11. APPENDICES 

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1. 
Design Summary  
2. 
Sample Informed Consent Form  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 Introduction 
 
1.1 P3 EQUATE Overview 
 
The P3OPPY Project is one of five projects within the 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 underserved populations. Collectively, our team will collaborate with pregnant and 
postpartum people and their families, hospitals, and communities to discover ways to reduce racism and social 
problems that contribute to poor health outcomes. 
 
1.2 P3OPPY Overview  
 
The purpose of the P3 Providing an Optimized and emPowered Pregnancy for You (P3OPPY) study is to evaluate 
promising interventions to reduce disparities and improve healthcare access and quality among pregnant women 
and their infants from historically marginalized communities. We will test the hypothesis that an innovative mobile-
health integrated care model and/or a community health worker integrated care model will improve pregnancy 
outcomes among women who experience persistent disparities. POPPY has three aims: 1) Qualitative aim to 
understand how best to tailor the digital health and community health worker interventions (this is addressed in a 
separate, previously approved IRB application), 2) a pilot randomized trial (n=40) randomizing eligible patients to 
a digital health intervention, a community health worker intervention, or both (covered in the enclosed application), 
3) a randomized trial of 400 pregnant patients to determine if digital health and/or community health workers can 
improve pregnancy outcomes (a future application). The enclosed protocol describes the activities of Aim 2, 
the pilot trial.  
 
1.3 Study Abstract 
 
US maternal mortality and preterm birth rates are among the highest in the developed world due, at least in part, 
to a combination of racial, regional and socioeconomic disparities. Our preliminary work demonstrates that 
differences in the Area Deprivation Index (ADI) are associated with racial/ethnic disparities in maternal and 
perinatal outcomes in Alabama. Patients living in resource-poor, or high ADI areas, may benefit from 
modifications at the patient-level to ensure equitable access to high-quality maternal care. The enclosed PᵌOPPY 
Pilot Study will determine if randomizing and implementing a digital health and/or community health worker 
interventions are feasible. 
 
1.4 Pilot Study Aims 
1. To assess the feasibility of the DHI and CHW interventions by assessing patient acceptance and use of 
the intervention.   
  
2. To assess study enrollment to determine appropriateness and usefulness of the inclusion and exclusion 
criteria to estimate enrollment duration in the planned trial. 
  
3. 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.)  
 
1.5 Purpose of Study Protocol 
The purpose of the P3 Providing an Optimized and empowered Pregnancy for You (PᵌOPPY) study is to 
evaluate promising interventions to reduce disparities and improve healthcare access and quality among 

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pregnant women and their infants from historically marginalized communities. The enclosed protocol for the pilot 
study will assess feasibility of randomization and implementation ahead of the planned clinical trial.  
 
A manual of operations supplements the protocol with detailed specifications of the study procedures. 
 
 
 
 
 

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2.Background 
 
Maternal health disparities in the United States (US) are disturbingly high — The US has the highest 
maternal mortality (MM) rate – 32.9 deaths per 100,000 live births – among industrialized countries, and Alabama 
has the third highest MM rate in the US 1, 2 . These starkly high rates are marked by persistent, unacceptable 
disparities. Unfavorable social determinants of health (SDoH), structural racism, and systemic barriers lead to 
suboptimal health outcomes in pregnant women from historically marginalized backgrounds 3, 4 In 2020, the MM 
rate for Non-Hispanic White (NHW) women in the US was 19.1 deaths per 100,000 births, while the MM rate for 
NHB women was nearly three times higher at 55.3 deaths per 100,000 live births.1 MM represents the “tip of the 
iceberg,” as each death represents numerous “near-misses” that the Centers for Disease Control and Prevention 
(CDC) captures in a severe maternal morbidity (SMM) composite of 21 outcomes that have profound short and 
long-term ramifications 5, 6. As summarized in a review by Sinkey (P3OPPY Co-PI), NHB women are also more 
likely to experience each component of the CDC SMM index versus NHW women 7. 
 
Our NIH-funded supplement (3UL1TR003096) on racial disparities in maternal mortality identified a 
significant linear relationship between increasing levels of area deprivation and increased SMM/MM (p<0.01) 
The effect was significant in the top three (most deprived) area 
deprivation index (ADI) quintiles. The ADI quantifies socioeconomic 
conditions linked to individual health outcomes 8. The ADI scale ranges 
from 0 – 100; 0 represents abundant resources and 100 represents the 
most impoverished community. Alabama patients residing in high- 
deprivation communities, defined as the 5th highest ADI quintile (Q), had 
78% greater odds of SMM/MM compared to patients living in resourced 
communities (defined as ADI Q1) (OR, 1.78; 95% Confidence Interval 
(CI), 1.22 – 2.59; p=0.003) (Table 1). Other factors including NHB race, 
age ≥35 years, residing in medically underserved areas and having 
Medicaid or Medicare insurance were also significantly associated with 
an increase in SMM/MM (under review for publication). Qualitative 
stakeholder interviews (n=20) conducted by our team identified several 
themes felt to contribute to persistent disparities in Alabama, including 
the legacy of racism, institutional distrust, lack of racial diversity in 
medical providers, poverty, lack of transportation and other needed 
infrastructure 9.  
 
Inequalities in infant outcomes are equally egregious — Infant mortality rates (IMR) in the US are also among 
the highest in the developed world due largely to a combination of higher gestational age (GA)-specific mortality 
among term infants and higher rates of preterm birth (PTB) 10.  We identified significant disparities in IMR and 
other adverse infant outcomes according to race11 and socioeconomic status (SES) 12 in the US and Alabama. 
Alabama’s IMR was 9.3/1000 births in 2016, and despite improving to 7.0/1000 in 2018, it remains significantly 
above the national IMR of 5.8/1000 and among the highest in the US. Our analysis of national data showed that 
inter-state IMR variation is highly correlated with rates of extremely PTB (r2 =0.71; p<0.001) that are closely 
related to the proportion of births to NHB women 13.  
 
In an ecological study of 6,901,328 US infants born in 2017-2018, we demonstrated that privately insured infants 
had a 30% lower IMR compared with Medicaid-insured infants after adjustment for race, sex, multiple births, and 
maternal pregnancy risk factors 14. Privately insured mothers had higher rates of first trimester prenatal care 
(PNC) (85.6% vs. 66.6%; p<0.001) and lower rates of infant morbidity, preterm births (PTB) and low birth weight 
(all p<0.001). Furthermore, Medicaid Enhanced PNC Programs are associated with lower IMR suggesting that 
interventions that enhance maternal pregnancy care improve infant outcomes 15. 
Table 1. Association Between ADI, Race, 
and SMM / MM Among Women Delivering 
at UAB Hospital 2010 – 2020 
Variables 
Adjusted OR* 
(95% CI) 
P-value 
Area deprivation index (quintiles) 
1st Quintile 
1.00 
2nd Quintile 
1.18 (0.95-1.47) 
0.143 
3rd Quintile 
1.47 (1.18-1.84) 
0.001 
4th Quintile 
1.55 (1.18-2.04) 
0.002 
5th Quintile 
1.78 (1.22-2.59) 
0.003 
Race 
NHW 
1.00 
NHB 
1.81 (1.42-2.30) 
<.001 
Hispanic/Latino 
0.84 (0.58-1.23) 
0.369 
*Odds ratio and 95% confidence intervals 
computed using Genmod procedure with 
repeated subject = census block group geoid to 
adjust for within-subject correlation. 

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In a recent study of 4 neonatal intensive care units by Travers 
(Co-I), NHB infants <29 weeks’ gestation lived in areas with 
higher ADI percentiles than similar NHW preterm infants 16.16 
Specifically, extremely preterm infants at UAB were more likely 
to 
be NHB and had a high median ADI (81, IQR 64-92) scores. 
There was a significant association between ADI and mortality 
after adjustment for baseline characteristics. Findings from the 
Jefferson County, AL Health Equity Team, led by Baskin (Co-I), 
align with Travers’ findings (Figure 1) 17 17. SDoH including racism and SES remain important independent risk 
factors for adverse infant outcomes. 
 
Digital health interventions (DHI) are promising channels to support improved outcomes in under-
resourced communities — Though COVID-19 exacerbated the many challenges facing maternal and child 
healthcare delivery, it simultaneously provided opportunities to redesign the delivery of care 18. One such 
opportunity is the use of the DHI short message service (SMS) which the Cochrane Review has shown to be a 
promising strategy for improving maternal, newborn, and child health 19. Although some studies show mixed 
results for text-based DHI interventions in low- and middle-income counties (LMIC) and high-income countries, 
others targeting pregnant and postpartum (PP) women have shown these interventions improved exclusive 
breastfeeding, increased PNC, and increased skilled attendants at birth where a lack of skilled attendants is 
common 20. While many patients receiving texts felt supported by DHI, others cited lack of network access, 
internet, or phone, and literacy or privacy issues as concerns 21. 
One of our EQUATE Partners, Mr. Rosin (P3OPPY Consultant), Chief Innovation Officer at Penn Medicine, in 
conjunction with Memora Health, developed a text-based DHI for maternal and newborn care that does not 
rely on a data plan or smartphone 22, 23. The DHI primarily works in two ways, 1) sending time-sensitive, 
culturally relevant educational texts and 2) replying to patients’ texts regarding medical concerns with artificial 
intelligence-driven algorithms. Since smartphones nor internet access are needed for text-based solutions, 
this is a potentially sustainable and scalable intervention. However, DHI solutions, while helpful, may not be 
able to replicate the in-person face-to-face support during pregnancy and PP. Thus, CHW will also be tested in 
our factorial design trial. 
 
Community health workers (CHW) comprise another promising, sustainable, and scalable strategy to 
improve maternal and child outcomes in under-resourced areas — There is substantial evidence 
supporting the effectiveness of integrating CHWs into the clinical care team 24.24 A 2022 systematic review 
investigating CHW interventions and maternal/child health concluded that CHW improved pregnancy and 
infant health knowledge, increased PNC, and reduced IMR in LMIC 25. CHWs are also known to both 
increase access to services and improve the quality of culturally competent care. In fact, the Community 
Preventive Services Task Force recommends using CHW based on multiple studies demonstrating 
reductions in health disparities (particularly related to cardiovascular disease (CVD)) and the cost- 
effectiveness of CHW use 26.26 Despite this, there is limited data on the integration of CHW in the US as 
part of a strategy to reduce racial disparities in maternal/child health. Preliminary data from the Connection 
Health CHW Program, from which the P3OPPY CHW program will be adapted, demonstrated that pregnant 
patients paired with a CHW had 100% smoking cessation and 77% fewer missed PNC appointments than 
SES-matched pregnant patients without a CHW. 
 
Community-based participatory research (CBPR) is a powerful strategy harnessing community 
partnerships at each stage of research — CBPR, an innovative research methodology that treats 
community members as equals in the research team 27, has transformative potential to improve 
maternal/infant health outcomes. In our previously mentioned qualitative interviews, stakeholders cited 
distrust of the medical system as a contributing factor in racial disparities in maternal death. The P3OPPY 

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Project provides an opportunity to mitigate this distrust through meaningful partnership. Our team (Baskin, 
Co-I and Scarinci, EQUATE Core) has extensive expertise in CBPR in the Deep South and other 
resource limited settings 28-30. 
 
A properly designed randomized 
controlled trial (RCT) grounded 
in a CBPR framework31 is urgently 
needed to investigate promising 
DHI and CHW interventions to 
reduce the disparities outlined 
above. As shown in Figure 2, our 
conceptual model identifies multi-
level contributors to 
racial disparities in maternal/ 
infant outcomes. Each of the two 
P3OPPY interventions has the 
potential to target various 
disparities in the EQUATE  
conceptual model. The proposed 
aims align with the overarching 
goal of the American Heart 
Association Health Equity 
Research Network on Disparities 
in Maternal-Infant Outcomes to 
“aggressively address SDoH 
while working to improve health 
equity for all communities.” 
 
 
 
Figure 2: SDoH, including Jim Crow, Slavery, the 13th Amendment, Redlining and the 
GI Bill are drivers of adverse SDoH. They coalesce to include the health and well-
being of women, infants, and their families, and are embodied in disparate outcomes 
for Black, indigenous and people of color 
 
 

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3. 
Preliminary Data from Qualitative Interviews from AIM 1 
 
What follows in this section 3 is a brief summary of recommendations from our one-on-one semi-
structured virtual interviews from Aim 1 occurring from November 2022 – January 2023 from community 
leaders and maternal child health service providers for community health worker programs and digital 
health interventions. Note that these data are preliminary and do not include findings from ongoing 
interviews.  
Interested parties were defined as clinical and alternative providers who provide health services to pregnant, 
laboring, and postpartum people and infants who identify as Black or African American in Alabama. Other 
interested parties were community leaders who work or volunteer with communities who primarily identify as 
Black or African American in Alabama. These included leaders of community-based organizations, faith-based 
leaders, educators, etc. outside of direct services in maternal and child health.  Focus was initially on Jefferson 
County, but we were inclusive of perspectives outside of the county to promote feasibility in scaling up the future 
pilot.   
Community Health Worker Intervention Recommendations: 
• 
Characteristics of CHW: 
o Emphasize these qualities as part of recruitment, hiring interview, and screening to match clients to 
CHWs. 
o Seek CHWs with the following:  
▪ 
Qualities:  Flexible, engaging, nonjudgmental, trustworthy, empathetic, charismatic, perceptive, 
approachable, respectful 
▪ 
Skills:  strong listening and communication, perceptive, professional, knowledgeable, educator, 
advocate, proactive, resourceful 
▪ 
Demographic Characteristics:  look like the participant/ relatable (i.e. mom, same race, similar 
background and/or from similar geographic area) 
• 
Training for CHW:  
o Training should include: content specific to pregnancy, postpartum maternal and infant care; difficult 
conversations, intrinsic bias training, leadership training, art therapy, active listening, and educational 
program to overcome loneliness offered by UAB chaplain group. 
o Have staff listen to questions from clients about current events, new research; staff read a study and 
report main points to the rest of the staff. 
o Set up brief meetings with local organizations around Birmingham so the staff know the resources and 
exact point of contact.  Have a running list and practice the “warm handoff” connection to services.  
• 
Connecting to Moms: 
o Communicating to General Community:  
▪ 
What? Promote and inform about the role, duties, and generally who a CHW is in general and 
within this context. 
▪ 
Who? Communicate with local leaders (informal and formal), pregnant people, and young 
families. 
▪ 
Where? At existing community events (i.e. health screenings, schools, continued 
communication at health department, Parent Teach Organizations, or other places community 
members frequent.   
o Pre-Meeting:  Screen centrally to match clients to CHWs based on similar characteristics when possible.   
o First Meeting:   
▪ 
Meet in-hospital or clinic. 

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▪ 
Have centralized screener introduce CHW to client via phone and let them decide where to 
meet initially.  Locations:  in client’s home or other nearby community gathering place- church, 
community center, restaurant, etc.  
o Other Visits:  Meet where client is comfortable. Ideally the phone calls initiated by the CHW will 
encourage the client to initiate communication to CHW too!  Over time, a relationship will be natural and 
meeting at home may become easier and more comfortable. Incentivize the program to encourage 
update.  Incentives may include care items for infants (formula, clothes, diapers, etc.) and partnering 
with corporations may offset these expenses.   
• 
Role and Duties:  
o Provide specific, inclusive description to clients, communities, and leaders.  
o Examples: Advocate for clients (prep client before an appointment to advocate for them self, attend 
appointments with them to advocate), answer questions about health, improve health literacy, remind 
and support in scheduling, securing childcare/ transportation for appointments, home visits for blood 
pressure other screenings like mental health issues; Communicate to avoid loneliness and isolation; 
Educate about nutrition, sleep, care for clients and infants, when to seek medical care vs. basic home 
care, connect to existing resources to meet all of family’s needs not just direct infant and maternal health 
services. 
• 
Timing/ Availability:  
o Set clear expectations during recruitment/ hiring for CHW to “meet client where they are”. This should 
include early evenings and weekends when clients may need to talk or have questions answered.   
o CHW should set and communicate with clients their clear expectations about their availability and what 
constitutes an emergency vs. nonemergency.  
o Visit/ communication frequency should change over time with more frequent communication in the first 6 
weeks versus more spaced out over time during the remaining months. 
• 
Concerns: 
o Confidentiality:   
▪ 
Communicate with clients and communities about the role, duties, and benefits of CHWs. 
▪ 
Clearly describe the training they receive and what information they are expected to keep 
confidential (i.e. not share with others in the community).  
▪ 
Consider using the example of provider/ patient confidentiality from the medical model (HIPAA) 
as some may be familiar with that.   
▪ 
Communicate clearly what they are required to report vs. the purpose they are there for.  
o Safety for CHW at in-home visits 
▪ 
Hire people from similar communities.  
▪ 
Set and communicate boundaries on visiting (times, days, and expectations for reporting so 
other members of the household are well-informed too.)  
 
 
Digital Health Interventions:  
• 
Mode:  
o Use text messages if possible.  Varied opinions on whether a text link to a secured app would be a 
deterrent to use.  
o Use option to “opt in” to avoid the feeling that it is invasive.   
• 
Interventionists/ facilitators:  
o Have a live person available to respond to questions about the messages. When they need to be 
available will vary widely.   

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▪ 
Avoid having to press 1 for this and press 2 for that phone trees that may feel complicated 
and inhuman.  Avoid “BOT” response when possible to promote tailored responses and 
health literacy. 
▪ 
Increase message acceptability with messages from a known person or ability to respond 
to a known person (like a CHW or other trusted source) rather than mass automated 
messages.   
o Have a person on the team who is interested in social media to be ahead of trends and increase 
user-friendliness.  
• 
Frequency/ timing:  
o Preferences for when the messages should be delivered varied.   
o Frequency should change over time with more depending on the stage of pregnancy or postpartum 
(i.e. more in the first 6weeks then fewer over time. Some suggested once per week then once per 
month.)  
o Avoid overwhelming people with too many messages (risk they will ignore). 
• 
Content of messages:  
o Messages should extend to current events and topics of interests for clients during their stage of 
pregnancy, delivery, and postpartum (i.e. move beyond providing info about vitamins during 
pregnancy).  
o Have programmed messages with flexibility.  Call upon content/ social media experts to create 
anticipate questions/ identify current events to develop and send messages to respond to timely 
questions. 
• 
Participant Access to Phone/ Data:  
o Interventionists should be flexible and understanding regarding access.  A client’s phone number 
may change. They may have limit on number of minutes or limited knowledge of device/ app 
features.  They may share a phone with a member of the household.  They may lack data or 
consistent WIFI and require going to a community place with WIFI.   
o Be proactive in communicating frequently and work with community (family, neighbors, and faith-
based leaders) to track down people’s new numbers and find places nearby where they can 
access WIFI for free. Work with different generations in a household or community to problem 
solve.   
• 
Confidentiality concerns:  
o Be aware of community concerns regarding existing programs for free/ reduced costs device or 
data plans. Concerns of being tracked by the government and at risk of losing their social service 
benefits. 
o Be aware about device/ data access issues and sharing (noted above).  
o Utilize CHW as a bridge to health system and digital health information. 
o Frame concerns around DHI confidentiality using examples from other telehealth or in-person 
health (i.e. CVS pharmacy script reminder to pick up, patient portal with provider’s office, are 
bound by HIPAA (explain HIPAA) and at risk of breach).   
 
 
 
 
 
 
 
 

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4. Study Design 
 
4.1 Primary Research Objective 
 
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 DHI and CHW 
engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for NHB mothers 
and their infants from underserved communities in Alabama and beyond. The objective of this pilot study is to 
determine if it is feasible to randomize and implement DHI and CHW interventions. 
 
4.2 Design Summary 
We will challenge existing care paradigms by testing the effectiveness of integrating innovative platforms into the 
existing healthcare system, including existing DHI and CHW programs from within our 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. We will specifically include NHB communities at the 
highest risk of adverse pregnancy outcomes and which were historically underrepresented in clinical research due 
to structural racism. Our cross-disciplinary collaboration effectively employs experts across the community, 
maternal, and infant health continuum. The use of community-based participatory research to tailor the digital 
health platform and optimize CHW activities/interactions represents a paradigm shift in pregnancy care. Novel 
technological innovations include the use of secure educational messaging and connection to local resources.  
 
For this pilot, we will randomize a total of 40 eligible participants, 10 to usual care, 10 to DHI, 10 to CHW, and 10 
to DHI + CHW 
 
4.3 Eligibility Criteria: 
 
Inclusion Criteria: 
•Self Identifies as NHB  
•Between 16-49 years old 
•8⁰ - 22⁶ weeks gestational age with a live fetus  
•Dating sonogram at <23 weeks gestation 
•ADI National 4th or 5th Quintile 
•Planning to deliver at UAB Hospital 
•Speaks and writes in English 
•No indication for delivery at the time of enrollment 
•Viable singleton or dichorionic twins 
 
Exclusion Criteria: 
•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 
 
4.4 Informed Consent Criteria 
     Written informed consent will be obtained from all participants. The risks, benefits and alternatives will be 
reviewed with the patient in detail. An informed consent form will be developed aligning with rules and regulations 
from the governing Institutional Review Board. A copy of the signed screening consent form will be provided to 
each participant. Both verbal and written informed consent will be obtained as needed; if this is not possible the 
patient will not be randomized.  

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5 Study Procedures 
5.1 Overview 
With feedback from qualitative interviews and ongoing partnership with the P3OPPY CAB, the DHI 
and CHW interventions developed in Aim 1 will be piloted in 40 pregnant NHB patients from high ADI 
(national quintiles 4&5) communities. The interventions will be implemented during pregnancy and will 
continue after birth until the infant reaches six weeks of life. 
 
5.2 Recruitment and Randomization 
All pregnant patients <23 weeks’ gestation will be screened for eligibility. The screening will occur in the 
inpatient and outpatient settings at UAB. In the inpatient setting, patients with limited or no prenatal 
care frequently present to the obstetric triage unit and/or to the emergency department for pregnancy 
care, yet this often does not translate to routine prenatal care leading researchers to conclude that 
these patients are “vulnerable” and “should be considered as a public health strategy worth 
investigating” 32, 33. The OB/GYN team is consulted on all obstetric patients in the ED and obstetric 
triage unit and a “New OB Lab Panel” is ordered by routine. If this panel is ordered in the ED or 
obstetric triage unit, a page will be sent to the CWRH research team (on-site 24/7), alerting them to 
screen the patient for P3OPPY. Additionally, the CWRH team will screen the clinic schedules for 
potentially eligible prenatal patients in outpatient obstetric clinics. Potential participants will then be 
approached for enrollment by a trained member of the CWRH team. 
The 1:1:1:1 randomization sequence will be uploaded by Dr. Szychowski, the Data Coordinating Center 
lead. Study team will be blinded to the randomization sequence.  
 
5.3 Procedures to Obtain Informed Consent 
Written informed consent will be obtained in person for entry into the study. Study staff will disclose the        
nature and potential risks of participating in the follow-up study. A common consent form template will be 
used for central IRB submission and adapted to institutional IRB requirements if relevant. This will comply 
with HIPAA Privacy Rules, and including authorization to obtain and review medical records. After the woman 
has had the opportunity to review the consent form and has had all questions answered to her satisfaction, 
she will initial and sign indicating her desire to participate.  
 
5.4 DHI intervention Overview:  
 
We will use a modified DHI developed by Memora Health in conjunction with EQUATE partners at 
UPenn 22, 23. All content is designed for 7th grade Flesch-Kincaid level or lower. We originally planned to 
utilize an SMS approach grounded by the literature 34-36 This approach is utilized by several major US 
academic centers. Unfortunately, we were informed by UAB legal that patients do not have the ability to 
consent to this as they interpret this as going against federal law. While we are disappointed in the result 
and view this as a barrier to improving outcomes for the most vulnerable, we have modified our approach to 
one approved by UAB legal. Memora will send a text message that has a link that the participant will launch. 
The educational byte is then launched in a secure browser and the link and message expire in 24 hours.  
 
 
Education bytes sent by Memora have been modified by the POPPY Study team through a series 
of bi-directional meetings held over the last year. The participants are sent on average 2 text links per week 
that have anticipatory guidance during pregnancy, postpartum, and for the newborn through approximately 6 
weeks of life / 6 weeks postpartum. There is a possibility you could be followed by this intervention for up to 

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3 months under qualifying circumstances. The qualifying circumstances are as follows: Intrauterine fetal 
demise (IUFD) and a loss of a baby.  The educational bytes are in accordance with the principles published 
by the American College of Obstetricians and Gynecologists (ACOG). The messages urge the participant to 
call the OB/GYN clinic or present to the UAB MEU if there are any concerns, and any alerts will be fielded to 
the POPPY email address covered by our research team during business hours. For example, in addition to 
the educational texts, a validated depression screen will be shared during pregnancy and postpartum. If the 
screen is positive, an alert will be emailed to the POPPY Email address and our team member will contact 
the patient and provide clinical resources. In the rare event that a participant states they are considering 
suicide, they are instructed to call 988 and to present to the MEU or the nearest emergency room 
immediately. Additionally, an email is sent to the POPPY email address and our team will follow up with the 
patient to ensure they sought care.  
 
 
In addition to the secure educational bytes, the DHI provides appointment-scheduling reminders 
and the link to KidOne that offers transportation services to pregnant patients, postpartum patients and their 
infants. In order to provide patients accurate educational bytes, our team will sync with Memora using the 
secure SFTP platform as recommended by HSIS that will share validated variables such as if the patient 
delivers, if the patient was diagnosed with preeclampsia, and if the infant is living or deceased.  
 
 
As this initiative is funded by the American Heart Association with the goal to reduce racial 
disparities in maternal morbidity and mortality, messages regarding common causes of death including 
infection, hypertension, hemorrhage, and heart failure are included.  
 
5.5 CHW intervention Overview: 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   

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to expectant mothers from the 1st trimester of 
pregnancy through their child's first year of life. 
FDO was developed and implemented by the 
Jefferson County Department of Health (JCDH) 
in collaboration with Connection Health, a non-
profit organization in Jefferson County, AL that 
recruits, trains, and deploys CHWs to address 
the needs of the most vulnerable communities. 
CHWs receive 90 hours of rigorous training 
including >50 hours of in-class instruction, case 
studies, group work, role-plays, and 20 hours of 
self-study and assessments. To date, 
Connection Health has trained over 165 CHWs 
who have successfully engaged >90% of 
pregnant mothers enrolled in FDO. In the 
present study we are collaborating with 
Connection Health to identify and train CHWs to 
implement a modified FDO program as part of 
the CHW and CHW+DHI intervention arms. 
Table 2 describes the CHW interventions 
planned which may be modified based on 
qualitative feedback in Aim 1. 
 
Based on feedback from our interviews and advisory board, participants randomized to the 
community health worker intervention will be connected to their CHW through the UAB Research 
team. The CHW will call the participant over the phone to introduce herself, and will offer to meet 
her at her doctor’s appointment (if she desires) or virtually based on the patient’s preference. The 
CHW will reach out to the participant every other week and specific activities are outlined in the 
enclosed table. Over time, a relationship will develop and it is our goal that the CHW will be seen 
by the participant as an advocate to navigate the healthcare system.  
 
In other research studies in conjunction with UAB, ConnectionHealth has entered into an IRB 
Authorization Agreement whereby the UAB IRB is the IRB of record for ConnectionHealth. We 
plan to use this same IRB structure for the POPPY Study.  
 
 
 
 
 
 
 
5.4 Virtual Visits (for CHW) if applicable 
If needed, the CHW will initiate a virtual visit in place of an in-person visit upon request by the participant.  
 Virtual visits can be conducted by phone, video chat applications, computer-based programs (i.e. Zoom, 
Microsoft Teams, WebEx), or other platform that the site or participant prefers. During the virtual visits, 
baseline and home assessments, questionnaire will be asked of the participant, educational information and 
reminders will be given. We will ask about any new diagnoses or medications.  
 
Stages 
Table 2: CHW Intervention* 
1st Trimester 
Baseline in-person assessment‖; Education on 
tobacco, drug and alcohol prevention; Diet and 
lifestyle education 
2nd Trimester 
Education on breastfeeding and birth control 
methods; Screenings on food insecurity; Diet and 
lifestyle education; Environmental Home 
Assessment 
3rd Trimester 
Host Baby Safety Showers to educate parents 
about infant safety, prevent childhood injuries, and 
infant nutrition 
Maternal 
Engagement 
Infant Engagement 
Delivery- 
associated 
hospitalization 
Follow-up within 48 
hours after notification 
of birth; Breastfeeding 
support 
Vaccine reminders and 
birth certificate 
completion support 
Postpartum 
Reminders to 
schedule PP visit; 
family planning / 
contraception 
education; PHQ.9; 
Home environment 
safety check; Home 
BP check for patients 
with HDP 
Reminder to register 
baby for WIC and 
insurance; Reminder for 
1 – 2 week pediatric 
check-up and 
immunizations and two 
months well check-up 
*CHWs also engage with client bi-weekly from enrollment until the infant is 
three months old and is available to assist with Medicaid enrollment, 
coordinate transportation through Kid One Transport, access to healthy food, 
access to diaper banks, and is available to attend prenatal and infant visits 
with the participant according to the patient’s wishes. ‖Includes vital signs, 
weight and 
medical and obstetric history; HDP = hypertensive disorders of pregnancy 

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5.5 In-person Visit / Procedures 
 
Here is the summary of the assessment visit across the enrollment 
 
Enrollment 
28 – 32 
weeks 
Delivery 
Discharge / Neo 
Discharge 
Postpartum 
Visit 
Screening and 
Randomization Form 
X 
 
 
 
Baseline Data Form 
including: 
X 
 
 
 
   Demographics 
X 
 
 
 
   Medical history 
X 
 
 
 
   Food insecurity 
X 
 
 
 
   Housing stability 
X 
 
 
 
   Social support  
X 
 
 
 
   Neighborhood / 
social environment 
X 
 
 
 
   Perceived 
Healthcare Access 
X  
 
 
 
Everyday 
discrimination scale 
X 
X 
X 
X 
Experience of 
discrimination  
X 
X 
X 
X 
PHQ-9 
X 
X 
X 
X 
Perceived Stress 
Scale 
X 
X 
X 
X 
MORI Form  
X 
X 
X 
X 
Prenatal course, 
breastfeeding plans 
 
X 
 
 
Health literacy 
 
X 
 
 
L & D Form (include 
prenatal 
course/complications) 
 
 
X 
 
Miscarriage or early 
termination form  
X 
 
 
 
Neonatal Form  
 
 
X 
 
NICU Form 
 
 
X 
 
Maternal Postpartum 
Follow up 
 
 
 
X 
Neonatal 
Readmission 
 
 
 
X 
Neonatal Well Being 
(combine with 
readmission?) 
 
 
 
X 
Intervention 
satisfaction form  
 
 
 
X 
SAE Form 
X 
X 
X 
X 

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Protocol Violation 
Form 
X 
X 
X 
X 
 
***Items in blue denote common data elements across the EQUATE Network endorsed by the Social 
Determinants of Health Core 
 
Medical history and questionnaire administration will be completed by site investigator or a trained delegate. 
Patients will be encouraged to have all medication present. In addition, participants will be asked to sign a 
medical record release so that medical records can be obtained and reviewed by the study team if not 
previously done.   
 
5.6 Adverse Event Reporting 
Detailed information concerning relevant adverse events will be collected and evaluated throughout the      
conduct of the protocol. Many of these including death, CVD morbidities, and hospitalizations will be collected as 
study outcomes. An Adverse Event Form will only be completed for any event that is not already being collected 
as an outcome that is serious, deemed related to the study, and/or unexpected in nature, severity or frequency. 
The Adverse Event form will be submitted within 7 days of becoming aware of Adverse Event. 
 
5.7 ADAPT-ITT: The ADAPT-ITT framework 37 will be used to adapt P3OPPY DHI and CHW interventions 
to make it culturally relevant to NHB women in low-resourced communities in Alabama. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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6. SAMPLE SIZE 
 
6.1 A convenience sample of 40 pregnant NHB patients from high ADI (national quintiles 4&5) communities 
will be randomized in the P3OPPY pilot.  
 
 
N= 40: Usual care (n=10), DHI alone (n=10), CHW alone (n=10), CHW+DHI (n=10) 
 
 
 
 

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7. DATA COLLECTION 
7.1 (eDES) Electronic Data Entry System  
Maternal/perinatal variables will be directly entered into the eDES database by trained CWRH staff. All 
data will be stored in UAB eDES on case report forms piloted by the P3OPPY study team and the 
EQUATE Data Management Core Staff. 
 
7.2 Data collection forms 
 
Detailed data collection forms will be included in an accompanying manual of procedures. 
 
 
 
 
 
 
 

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8. STUDY ADMINISTRATION 
 
8.1 Organization and Funding 
The study is funded by the American Heart Association (AHA). A complete description and listing of the 
participating centers is provided in the Manual of Operations. 
 
   
8.2 STUDY TIMETABLE 
 
 
 
EQUATE Network Members are underlined. 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix A 
 
P3OPPY Providing an Optimized and emPowered Pregnancy for You 
Aim 2: With feedback from qualitative interviews and ongoing partnership with the P3OPPY CAB, we will assess the feasibility to 
randomize and implement the DHI and CHW interventions in 40 pregnant NHB patients from high ADI (national quintiles 4&5) 
communities.  
 
Organization: 
 
Clinical Centers: University of Al at Birmingham (Clinical Coordination) 
Data Coordinating Center: University of Al at Birmingham Dept. of Biostatistics School of Public Health 
Funding Source: The American Heart Association 
 
Design: The purpose of the P3 Providing an Optimized and 
emPowered Pregnancy for You (P3OPPY) study is to evaluate 
promising interventions to reduce disparities and improve health 
care access and quality among pregnant women and their infants 
from historically marginalized communities. In this pilot we will 
assess whether it is feasible to randomize and implement DHI and 
CHW interventions.  
  
Inclusion Criteria:   
•Self Identifies as NHB  
•Between 16-49 years old 
•8⁰ - 22⁶ weeks gestational age with live fetus  
•Dating sonogram at <23 weeks gestation 
•ADI National 4th or 5th Quintile 
•Planning to deliver at UAB Hospital 
•Speaks and writes in English 
•No indication for delivery at time of enrollment 
•Has a smartphone 
•Viable singleton or dichorionic twins 
 
 
 
 
Exclusion Criteria: 
• Declined randomization 
• Speaks or writes in language other than English 
• Currently incarcerated 
• Fetal demise diagnosed prior to enrollment 
• Known major structural or chromosomal abnormalities prior to 
enrollment 
 
Sample Size: 40 Non-Hispanic Black Women 
 
Aim: To assess the feasibility of randomizing and implementing 
the DHI and CHW interventions in 40 NHB pregnant women from 
high ADI communities.    
 
Measures: SDOH Measures as per EQUATE SDOH Core, 
Perceived stress scales PHQ-9 and Mother on respect index 
(MORI) 
 

 
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Appendix B – Abstract submitted to the American Public Health Association Meeting resulting 
from Aim 1 data 
 
 
Community and provider perspectives on community health worker strategies to reduce 
maternal health inequities in Alabama 
 
Molly Richardson, PhD, MPH1, Angelina Toluhi, MD, MPH1, Rosylen Quinney2, Donna Dunn2, Henna 
Budhwani, PhD, MPH3, Vivek Shukla, MD2, Alan Tita, MD2, Colm Travers, MD2, Martha Wingate, DrPH, 
MPH1, Brian Casey, MD2, Trinita Ashford4, Lynetta West4, Kayla Torres4, Waldemar Carlo, MD2, Rachel 
Sinkey, MD2 and Janet Turan, PhD, MPH1 
 
Abstract: 
Objective: Despite ongoing efforts to reduce inequities in maternal mortality, Alabama has the third 
worst maternal mortality ratio in the United States. We aimed to identify community and provider 
perspectives to inform the development of a community health worker (CHW) program to reduce 
adverse pregnancy outcomes among non-Hispanic Black (NHB) pregnant women in Alabama. 
Methods: We purposively recruited key informants who work with NHB populations in historically 
underserved locations in Alabama. A semi-structured interview guide was informed by Andersen’s 
Behavioral Model of Healthcare and revised with the help of a community advisory board (CAB). Twenty 
in-depth interviews were conducted virtually. Rapid qualitative analysis approaches were used to 
identify recommendations for CHW interventions. 
Results: Participants included maternal health providers (n=10, clinicians, doulas, lactation consultants, 
social workers) and community leaders (n=10, faith-based leaders, educators, and community-based 
organization representatives). Participants identified the importance of having CHWs with similar socio-
demographic characteristics to clients in order to enhance relationship development. Participants also 
emphasized the need to clearly describe CHW’s role, duties, and benefits to clients and community 
members. They recommended specific trainings for CHWs, providing guidelines for their safety, and 
talked about the need to address concerns over confidentiality. Overall, interviewees were optimistic 
that a CHW program could successfully reduce maternal health disparities. 
Conclusions: These contextually appropriate preliminary recommendations, as well as findings from 
ongoing interviews with NHB patients who experienced adverse pregnancy outcomes and their family 
members, will be incorporated into a CHW intervention to be pilot-tested in the next phase of the study. 
 
 
 
 
 
 
 
 
 
 

 
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Appendix C  – Abstract submitted to the American Public Health Association Meeting resulting 
from Aim 1 data 
 
The potential for digital health interventions to improve pregnancy outcomes in historically 
marginalized communities in Alabama. 
 
Angelina Toluhi, MD, MPH1, Molly Richardson, PhD, MPH1, Rosylen Quinney2, Donna Dunn2, Henna 
Budhwani, PhD, MPH3, Vivek Shukla, MD2, Colm Travers, MD2, Martha Wingate, DrPH, MPH1, Brian 
Casey, MD2, Roy Rosin, MBA4, Alan Tita, MD2, Eric Wallace, MD, FASN2, Waldemar Carlo, MD2, Rachel 
Sinkey, MD2 and Janet Turan, PhD, MPH1 
 
Abstract: 
Objective 
Racial disparities in maternal health outcomes persist in Alabama. Our multidisciplinary team sought to 
identify provider and community perspectives on the potential use of digital health interventions (DHIs) 
to reduce racial disparities in maternal and child health (MCH) and to inform tailored DHI interventions 
for Black pregnant women Alabama. 
Methods 
A semi-structured interview guide was developed using Andersen’s Behavioral Model of Healthcare 
Utilization with input from a Community Advisory Board. We conducted 20 qualitative in-depth 
interviews with purposively selected participants including MCH providers (N=10: doulas, social 
workers, government agency staff) and community leaders (N=10: pastors, educators, and community-
based organization representatives). Coding and analysis of transcripts using the NVivo software 
resulted in emergent themes. 
Results 
Participants identified DHIs currently available across Alabama including texting programs, 
mobile/computer applications, telehealth/telemedicine, and patient portals. Facilitators for DHI utilization 
included patient awareness and user friendliness of DHIs. Participants felt that the advantages of DHIs, 
including easy access to health information and improved communication with the health system, 
outweighed disadvantages such as lack of internet/WiFi access in some areas, cost of smartphones, or 
privacy issues. Participants emphasized the importance of determining the optimal timing, frequency, 
and content of messages in texts, as well as ensuring ease of access to patient portals and applications 
for local communities. 
Conclusion 
Results indicate that DHIs show promise for addressing maternal health needs of Black pregnant 
individuals in Alabama. Future MCH interventions for this population can include the development and 
testing of accessible and user-friendly DHIs in collaboration with local communities. 
 
 
 
 
 
 

 
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