Official Title
COVID-19 Experiences in the SELF Cohort: A Cross-Sectional Study
Brief Summary

Background:COVID-19 affected African Americans more than Whites. African Americans, especiallywomen, have had higher rates of COVID-19 infections compared to Whites. They are alsomore likely to go to the hospital or die of this disease. Many researchers who lookedinto these issues lacked background data on the people they studied. SELF is a 10-yearstudy of fibroids in African American women aged 23-35. Researchers already have a lot ofdata on these women. Asking how COVID-19 affected them can add context other studieslack.Objective:To describe the impact of the COVID-19 pandemic on young African American women and theirfamilies.Eligibility:Participants must be enrolled in SELF (Study of Environment, Lifestyle, and Fibroids).Design:Researchers will invite all women enrolled in SELF to participate in this natural historystudy.Participants will complete one questionnaire. They will answer the questions online. Theymay also choose to get a paper copy sent by mail. The survey will take no more than 15-20minutes.All questions will relate to COVID-19. Participants will be asked if they had COVID-19.They will be asked if family, friends, or members of their community did. They willanswer questions about their vaccine status and access to health care services.Participants will also answer questions about how the pandemic affected their lives. Theywill be asked about their job and if finding childcare was a challenge. They will beasked about money problems and how they coped. They will be asked about sleep problemsand emotional distress.Participants will get a $30 gift card after they finish the survey.

Detailed Description

Study Description:

This cross-sectional study will be an add-on to the Study of Environment, Lifestyle and
Fibroids (SELF) (Protocol Number: 10-E-N044). SELF is a prospective cohort study of
fibroid development. From November 2010 to December 2012, the study enrolled a volunteer
sample recruited from Detroit, MI and surrounding areas of approximately 1,700
African-American women ages 23-35 without a diagnosis of fibroids. SELF has been a rich
information source regarding the health of young African-American women.

This current COVID-19 study will focus on collecting information regarding SELF
participant s experiences throughout the COVID-19 pandemic through a short, one-time
online questionnaire. The questionnaire will contain questions on a range of topics
related to the COVID-19 pandemic to include 1) pandemic experiences in the following
domains: COVID-19 illness of participant (including LONG-COVID), participant s family and
friends, participants social community 2) vaccination status, 3) access to health care,
4) employment vulnerabilities and employment loss, 5) challenges with caring for
children, 6) financial hardship, coping strategies, 7) sleep problems, and 8)
psychosocial stressors. The questionnaire will also ask questions about COVID-19-related
symptoms, vaccination, and hospitalizations experienced by the participants and/or
members of her household and community.

Objectives:

Primary Objective:

To describe the impact of the COVID-19 pandemic on reproductive-aged African American
women and their families. We have three goals:

First, these basic data will be summarized in a report that will be sent back to the
participants. Like our newsletters, this will serve as a cohort maintenance activity,
keeping our participants interested and engaged in the study.

Secondly, SELF collaborators are continuing to follow the participants (the 4th follow-up
is in progress, and a 5th follow-up is being planned), so these data will allow us to
consider the impact of COVID-19 in future analyses. Additional studies with this cohort
could also be undertaken in the future. Depending upon the exposure outcome being
investigated in the data from those additional follow ups, an overall measure of impact
may be important, or the impact on specific domains may be of most interest.

Thirdly, we also view this study as an opportunity to document the impact of the COVID-19
pandemic, a once in a century event, in a well characterized group of reproductive-aged
African-American women whose health and well-being have been followed for nearly a decade
now. This is an understudied group and documenting their response to COVID will serve as
one of several case-studies of specific subpopulations that are likely to emerge after
the pandemic. The goal is to document the range of adverse impacts experienced and the
factors (e.g., low income, limited educational attainment, pre-pandemic health
conditions, neighborhood factors) that might mitigate or exacerbate those adverse impacts
for this understudied demographic group.

Endpoints:

Primary Endpoint: Descriptive data on impact of the COVID-19 pandemic on
reproductive-aged African American women and their families

Enrolling by invitation
COVID-19
Eligibility Criteria

- INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

- Ongoing enrollment in the NIEHS s Study of Environment, Lifestyle & Fibroids (SELF)
cohort (i.e. not deceased or previously withdrawn from SELF)

- Ability to complete the questionnaire (indicating informed consent)

EXCLUSION CRITERIA:

-Not enrolled in the NIEHS the NIEHS s Study of Environment, Lifestyle & Fibroids (SELF)
cohort (i.e. not deceased or previously withdrawn from SELF)

Eligibility Gender
Female
Eligibility Age
Minimum: 23 Years ~ Maximum: 35 Years
Countries
United States
Locations

National Institute of Environmental Health Sciences (NIEHS)
Bethesda, Maryland, United States

Chandra L Jackson, Ph.D., Principal Investigator
National Institute of Environmental Health Sciences (NIEHS)

National Institute of Environmental Health Sciences (NIEHS)
NCT Number
Keywords
Fibroid
Natural History
MeSH Terms
COVID-19