Women s Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH) Equity

NCT04983251 | Recruiting

• 2 other identifiers: 10000441000441-E
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Inequalities in COVID-19 infection, hospitalization, and death in under-studied, under-represented, and under-reported groups of people are severe. A growing number of studies have assessed the impact of individual risk factors. But few studies have assessed which factors are the greatest drivers of COVID-19 disparities from a wider perspective. Objective: To understand the long-term impacts of COVID-19 on minority women and their families to assist in developing community-based programs to help in recovery. Eligibility: Healthy people aged 18 and older who reside in North Carolina. Design: Participants will take a 45-minute online survey. The survey will cover their demographics, community, health, lifestyle, household, and environment. Participants may choose to have tests. They may visit the Clinical Research Unit. They may also have a home visit for these tests. In some cases, they may mail samples to the study team in prepaid envelopes. Participants may take an optional 15 minute survey about their reproductive history. Participants may give a blood sample. Participants may give a urine sample. They will fill out a log and return with their sample. Participants may give saliva samples. Participants may give toenail samples from each toe. Participants may give dust samples. They will be given 8 alcohol swabs. Two will be for testing. They will be asked to swipe a total of 3 door frames. Each door frame should be in a different room of the house. Participants may be given silicone wristbands to wear for 1 week. This is to measure their exposure to air pollutants. Participants may be contacted in the future for follow-up. They may be contacted by phone, email, or letter.

Conditions

Mental Health

Keywords

Disparities; Vaccination; COVID-19; Natural History

Outcome Measures

Primary Outcomes (1)

• Characterize the mental, physical, and socio-economic effects

  (1)Characterize the mental, physical, and socio-economic effects of the COVID-19 pandemic on women in under-studied, under-represented, and under-reported (U4) populations within a syndemic framework. (2) Determine whether there was a worsening of mental, physical, and socio-economic status before, during, and following the COVID-19 pandemic. (3) Characterize the biological, behavioral, environmental, sociocultural, and structural impacts of the COVID-19 pandemic on factors that affect reproductive risk factors among U4 women.

  2 years

Secondary Outcomes (1)

• Quantify cross-sectional associations between retrospective pre-pandemic indicators of U4 status and related exposures

  2 years

Study Arms (1)

U4 Women

Women in under-served, under-studied, under-represented, and under-reported (U4) populations.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women will be recruited from a community-based sample in North Carolina following a recruitment plan developed in collaboration with Women's Health Awareness (WHA) partners.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Females who are African American or Black, Hispanic or Latino, American Indian or Alaska Native, Asian American, Native Hawaiian or other Pacific Islander.
• Aged 18 years or older.
• Reside in North Carolina.
• Be willing to provide photo ID
• Able to read and understand English in order to complete surveys (questions validated in English) and logs.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.

Sponsors & Collaborators

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

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Psychological Well-Being; COVID-19

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joan P Packenham, Ph.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaslyn A Grullon

CONTACT

(984) 287-4999; jaslyn.grullon@nih.gov

Joan P Packenham, Ph.D.

CONTACT

(919) 541-0766; packenhm@niehs.nih.gov

Study Design

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

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: July 30, 2021
• Study Start: June 30, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04-24

Locations

US (1)