COVID-19NCT05369611
COVID-19 Experiences in the SELF Cohort
An observational study of COVID-19, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 23 to 35 years, women only
- Conditions the study is for
- COVID-19
- How many people
- 1,197 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will be the 1,668 current members of the SELF (10E0044) cohort. These are African American women who were between the ages of 23-35 at enrollment in SELF who, to date, have not previously withdrawn from SELF and are not known to have died
Who may be able to join
- 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enrollment in the NIEHS s Study of Environment, Lifestyle \& Fibroids (SELF) cohort (i.e. not deceased or previously withdrawn from SELF)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)
Who cannot join
- -Not enrolled in the NIEHS the NIEHS s Study of Environment, Lifestyle \& Fibroids (SELF) cohort (i.e. not deceased or previously withdrawn from SELF)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Environmental Health Sciences (NIEHS)
Bethesda, Maryland, 20892
About this study
Official title: COVID-19 Experiences in the SELF Cohort: A Cross-Sectional Study
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.
Read more
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.
...
Read the 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
- Conditions
- COVID-19
- Keywords
- Fibroid, Natural History
- Medical subject headings
- COVID-19, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SELF | 1,668 current members of the SELF cohort: African American women between the ages of 23-35 at enrollment in SELF who have not previously withdrawn from SELF and are not known to have died. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19
Primary Endpoint: Descriptive data on impact of the COVID-19 pandemic on reproductive-aged African American women and their families
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start17 Jun 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Chandra L Jackson, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369611
- Sponsor's protocol ID
- 10000811
- Other IDs
- 000811-E
- Status last verified
- 9 Sep 2026
- First submitted
- 7 May 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Experiences in the SELF Cohort: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05369611
- Acronym / sponsor ID
- 10000811
- Conditions
- COVID-19
- Keywords
- Fibroid, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,197 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SELF | – | –1,668 current members of the SELF cohort: African American women between the ages of 23-35 at enrollment in SELF who have not previously withdrawn from SELF and are not known to have died. |
Who may qualify
- Ages
- 23 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be the 1,668 current members of the SELF (10E0044) cohort. These are African American women who were between the ages of 23-35 at enrollment in SELF who, to date, have not previously withdrawn from SELF and are not known to have died
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- -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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID-19
Time frame: 24 months
Primary Endpoint: Descriptive data on impact of the COVID-19 pandemic on reproductive-aged African American women and their families
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandra L Jackson, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 5 Nov 2026.