Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05369611 |
| Other study ID # |
10000811 |
| Secondary ID |
000811-E |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 17, 2022 |
| Est. completion date |
December 30, 2025 |
Study information
| Verified date |
June 11, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
COVID-19 affected African Americans more than Whites. African Americans, especially women,
have had higher rates of COVID-19 infections compared to Whites. They are also more likely to
go to the hospital or die of this disease. Many researchers who looked into these issues
lacked background data on the people they studied. SELF is a 10-year study of fibroids in
African American women aged 23-35. Researchers already have a lot of data on these women.
Asking how COVID-19 affected them can add context other studies lack.
Objective:
To describe the impact of the COVID-19 pandemic on young African American women and their
families.
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 history
study.
Participants will complete one questionnaire. They will answer the questions online. They may
also choose to get a paper copy sent by mail. The survey will take no more than 15-20
minutes.
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 will answer
questions about their vaccine status and access to health care services.
Participants will also answer questions about how the pandemic affected their lives. They
will be asked about their job and if finding childcare was a challenge. They will be asked
about money problems and how they coped. They will be asked about sleep problems and
emotional distress.
Participants will get a $30 gift card after they finish the survey.
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
