COVID-19 Experiences in the SELF Cohort

NCT05369611 | Enrolling By Invitation

• 2 other identifiers: 10000811000811-E
• Study Type: observational
• Target: 1,668
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

COVID-19

Keywords

Fibroid; Natural History

Outcome Measures

Primary Outcomes (1)

• COVID-19

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

  24 months

Study Arms (1)

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of the SELF cohort: African American women between the ages of 23-35 at enrollment in SELF who have not previously withdrawn from SELF and are not known to have died.

Eligibility Criteria

• Age: 23 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

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in the NIEHS the NIEHS s Study of Environment, Lifestyle \& Fibroids (SELF) cohort (i.e. not deceased or previously withdrawn from SELF)

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

National Institute of Environmental Health Sciences (NIEHS)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

COVID-19; Leiomyoma

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Chandra L Jackson, Ph.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 11, 2022
• Study Start: June 17, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04-27

Locations

US (1)