Impact of COVID-19 on Marshallese Communities in the U.S.
Conditions: COVID-19
Sponsor: University of Arkansas

Version #: 3 
IRB#261131 
Date: 20200915 
Page 1 
 
 
 
Study Title: 
Impact of COVID-19 on Marshallese Communities in the U.S. 
 
Principal Investigator:  
Pearl Anna McElfish, PhD 
University of Arkansas for Medical Sciences Northwest 
1125 North College Avenue 
Fayetteville, AR 72703 
Telephone: 479-713-8680 
Email: pamcelfish@uams.edu 
 
Co-Investigator: 
Holly Felix, PhD 
University of Arkansas for Medical Sciences Northwest 
1125 North College Avenue 
Fayetteville, AR 72703 
Telephone: 479-684-5117 
Email: felixholly@uams.edu 
 
 
 
Study location: 
University of Arkansas for Medical Sciences Northwest 
4301 West Markham Street 
Little Rock, AR 72205 
 

Title: Impact of COVID-19 on Marshallese Communities in the U.S. 
PI: Pearl McElfish 
Version #: 3 
IRB#261131 
Date: 20200915 
Page 2 
Background and Rationale 
While there is much we do not know about the differential effects of COVID-19, early data 
shows that minority communities are disproportionally effected by the virus.1-4 There are many 
factors that may increase the likelihood of contracting COVID-19 including: 1) community 
spread because of lack of access to testing in low-income communities, 2) work environments 
that may increase exposure, 3) more densely populated housing that reduces the ability to social 
distance, 4) limited understanding of preventive measures due to literacy and language barriers, 
5) constrained financial resources to stay home and not work, and/or 6) lack of trust in the health 
care system. The Marshallese are a Pacific Islander population experiencing significant health 
disparities with some of the highest documented rates of type 2 diabetes mellitus (T2DM) of any 
population in the world.5-7 Estimated type 2 diabetes rates among Marshallese in the United 
States range from 25%-50%, 400% higher than the general US population.5,8 People with 
diabetes are more likely to experience severe symptoms and complications when infected with 
COVID-19; however, those that manage their diabetes well are less likely to become extremely 
ill from the virus.9 In order to reduce the disparities caused by COVID-19 and ultimately 
compare the effectiveness of prevention interventions among the low-income minority 
communities most effected by COVID-19, it is critical to understand minority populations’: 1) 
risk exposure, 2) knowledge of preventive recommendations, 3) barriers and facilitators to 
implementing preventative recommendations, 4) barriers and facilitators to COVID-19 testing 
when appropriate, and self-care behaviors during COVID-19. 
 
Specific Aims 
Aim 1: Document COVID-19 risk exposure for Marshallese community members. 
Aim 2: Document Marshallese community members’ knowledge of preventive 
recommendations. 
Aim 3: Document barriers and facilitators to implementing preventative recommendations. 
Aim 4: Document Marshallese community members’ barriers and facilitators to COVID-19 
testing when appropriate. 
Aim 5: Document self-care behaviors during COVID-19. 
Aim 6: Explore COVID-19 pandemic related barriers and facilitators to diabetes self-
management among Marshallese adults with T2DM. 
Aim 7: Assess the effect of the COVID-19 pandemic on diabetes self-management activities 
among Marshallese adults with T2DM. 
 
Study Design and Procedures 
Up to 2000 Marshallese will complete an online or telephone survey. Up to 100 participants will 
be invited to complete an in-depth qualitative interview.  
The study will be advertised by posting an informational flyer on social media. The flyer will 
contain a link to the study information sheet and survey documents. Study team members will 
also reach out to study participants via phone or electronic mediums (e.g. email, text, or 
messenger). Study staff will send potential participants a link to an electronic survey using 
REDcap.10 The REDcap system will include electronic documentation of consent prior to 
completing the survey. Participants electing to access the survey through a telephone interview 
rather than the online process will be read the study information sheet before the survey 
instrument is completed. For those randomly selected to complete an in-depth qualitative 
interview, study team members will recruit them via phone or electronic mediums (e.g. email, 
text, or messenger) and schedule the interview by phone or secure web connection such as 

Title: Impact of COVID-19 on Marshallese Communities in the U.S. 
PI: Pearl McElfish 
Version #: 3 
IRB#261131 
Date: 20200915 
Page 3 
ZOOM, Skype, or Facebook. 
 
Study Population 
We will recruit up to 2000 Marshallese participants for the study. As part of UAMS IRB study 
#207034, the study team has recruited 386 Marshallese participants.11 378 of these participants 
have consented to be contacted for future studies. Additional Marshallese participants will be 
recruited through our engagement network if needed to rapidly reach recruitment goals. 
Community based recruitment will be achieved by posting the survey information on websites 
and Facebook. 
Participant inclusion criteria: 
1) Self-reported Marshallese 
2) 18 years of age or older 
3) Live in the Continental U.S. or Hawaii 
 
Measures/outcomes 
Using a mixed-methods concurrent triangulation design,12-18 the study team will utilize a survey 
and interview guide. Our survey and interview will be based on CDC risk assessments19,20 and 
utilize the NIH funded COVID-19 items that are part of the PhenX Toolkit.21 See survey 
attached. Those participants with T2DM will be asked to complete questions pertaining to 
diabetes management during COVID-19. 
 
Potential risks to study participants are minimal and no greater than usual care or standard health 
screenings. There is a potential risk for loss of confidentiality. Measures to protect the 
confidentiality of study participants will be implemented as described in the Data Handling and 
Recordkeeping section. The alternative to participating in the interventions is to not participate in 
the interventions. Further, any participant can choose to leave the study at any time. 
 
Remuneration: Each participant who completes the survey will receive a $20 Walmart gift card 
for remuneration and each person who completes the qualitative interview will receive an 
additional $40 Walmart gift card in remuneration. Participants will only receive gift cards for the 
part of the study they complete. 
 
Protections against risk. All data collectors involved in the interventions will have received 
training on: participant consent procedures, the study protocol, human subjects protection, 
HIPAA regulations, survey administration, maintaining confidentiality of study participants, 
mandatory reporting, and appropriate treatment of participant data. Access to study data will be 
limited to only those personnel who need it to complete relevant job duties. All data, regardless 
of whether it is identifiable or not, will be stored in a locked file cabinet in a locked room, or on 
a secure UAMS server that requires two-factor authentication. 
 
Potential Benefits of the Proposed Research to Human Subjects and Others 
There will be no direct benefits to the study participants; however, knowledge gained from the 
study could potentially benefit patients in the future. 
 

Title: Impact of COVID-19 on Marshallese Communities in the U.S. 
PI: Pearl McElfish 
Version #: 3 
IRB#261131 
Date: 20200915 
Page 4 
Data Capture 
The survey will be captured through REDcap10 or telephone interview and will take 
approximately 30 minutes to complete. Qualitative interviews will be conducted by phone or 
secure web connection such as ZOOM, Skype, or Facebook. A semi-structured interview guide 
will be used to ensure consistency across the interviews. The interview guide will also allow 
participants to discuss in their own words their lived experiences related to COVID-19. Each 
interview will have an anticipated duration of one hour. Qualitative data from interviews will be 
audio recorded, transcribed, and translated verbatim. 
 
Data Handling and Recordkeeping 
The Principal Investigator and study team will carefully monitor study procedures to protect the 
safety of research subjects, the quality of the data, and the integrity of the study. Access to study 
data will be limited to only those personnel who need it to complete relevant job duties and who 
have completed all required trainings for study activities and in maintaining confidentiality. 
Participant identification numbers will be used to track study forms. All records will be retained 
consistent with the UAMS Administrative Guide (seven years after final reporting or publication 
of a project). 
 
Data Analysis 
In a mixed-method concurrent triangulation design, study data is analyzed separately and then 
combined during the interpretation phase.12-18 This method will allow us to cross-validate and 
confirm study findings to provide a more complete illumination of the research question. The 
mixed-method concurrent triangulation design will allow us to overcome the inherent 
weaknesses of using qualitative or quantitative methods separately. Quantitative data analysis of 
the survey results will include descriptive as well as inferential statistical techniques, including 
correlation, t-tests, and non-parametric tests. Given the descriptive nature of the study aims, the 
analytic strategy will focus on presenting results of item-level descriptive analyses, with an 
emphasis on frequencies and proportions. Inferential analyses will focus on comparing groups of 
respondents who may be expected to have differences in risk exposure, knowledge, barriers and 
facilitators from one another (e.g., comparisons between respondents with different education 
and/or income levels, English proficiency, job sectors). For inferential analyses, alpha will be set 
at .05 two-tailed, and effect size indicators will be included. 
 
For each descriptive and inferential analysis, each respondent's data will be included if she or he 
responded to the relevant items, regardless of the amount of missing data for that respondent on 
other items. However, there will be no attempt to impute missing responses for any items. For 
each analysis, the number of included responses will be reported. 
 
Researchers with qualitative research experience will code the text of the open-ended questions 
for emergent themes. In order to rapidly assess the large number of open-ended responses, a 
coding template is the most appropriate and effective strategy to analyze the text.22,23 The initial 
coding template will categorize responses based on the a priori themes.. As the data is coded, 
emergent themes will be identified and incorporated into the template. The data will then be 
extracted from the open-ended responses and incorporated into the codebook in order to provide 
illustrative excerpts from the responses for each theme or domain they best represent. 
Confirmation coders will then review the data. Finally, the study team will confirm that the data 
and illustrative excerpts are applied to the correct domain by critically reviewing each analytic 

Title: Impact of COVID-19 on Marshallese Communities in the U.S. 
PI: Pearl McElfish 
Version #: 3 
IRB#261131 
Date: 20200915 
Page 5 
product to ensure rigor and reliability. Any discrepancies in interpretation will be discussed and 
resolved via consensus of the three coders. 
 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations and 
University of Arkansas for Medical Sciences research policies and procedures. This protocol and 
any amendments will be submitted and approved by the UAMS Institutional Review Board 
(IRB). 
 
Study team members will share the recruitment flyer on social media and also reach out to 
potential participants via phone or electronic mediums. Those potential participants who express 
interest in taking part in the study will be sent a link to an electronic survey using REDcap.10 The 
REDcap system will include written information about the study prior to completing the survey. 
Participants electing to access the survey through a telephone interview rather than the online 
process will be read the study information sheet before the survey instrument is completed. For 
those randomly selected to complete an in-depth interview, study team members will recruit 
them via phone or electronic mediums (e.g. email, text, or messenger). Prior to collecting 
qualitative data, the study information sheet will be provided again prior to data collection. 
 
This is a minimal risk study and a waiver of documentation of consent is requested. The research 
involves no more than minimal risk to the subjects and the research involves no procedures for 
which written consent is normally required outside of the research context. 
 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The publications 
will not contain any identifiable information that could be linked to a participant. The study will 
be listed on clinicaltrials.gov in accordance with (funder and/or journal) requirements. 
Aggregated results may be returned to participants in an infographic that is provided by e-mail to 
the participants if we have their email address. We will also work with stakeholders to 
disseminated aggregated information in town hall meetings. 
 

Title: Impact of COVID-19 on Marshallese Communities in the U.S. 
PI: Pearl McElfish 
Version #: 3 
IRB#261131 
Date: 20200915 
Page 6 
 
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Title: Impact of COVID-19 on Marshallese Communities in the U.S. 
PI: Pearl McElfish 
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Date: 20200915 
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23. 
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