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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health

Detailed Description

Study Description:

This is a cross-sectional population-based survey designed within a syndemic framework to characterize the impacts of the COVID-19 pandemic on women in under-served, under-studied, under-represented, and under-reported (U4) populations. We hypothesize that U4 women are experiencing and will have experienced a worsening of mental, physical, and socio-economic status as a result of the COVID-19 pandemic and that pre-pandemic indicators of U4 status and related exposures will be associated with adverse mental, physical, and SES effects of the COVID-19 pandemic. The study ultimately seeks to collect baseline data for a long-term follow-up study of U4 women, as well as identify high impact targets for public health interventions to build resiliency in U4 communities.

Objectives:

Primary Objectives:

1. Characterize the mental, physical, and socio-economic effects of the COVID-19 pandemic on women in under-served, 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 reproductive risk factors among U4 women.

Secondary Objectives:

1. Quantify cross-sectional associations between retrospective pre-pandemic indicators of U4 status and related exposures (i.e., urban vs. rural; pre-existing physical and mental health disparities; risk factors for maternal mortality; experiences of racism; social factors, and environmental, occupational, and housing exposures) with adverse mental, physical, and SES effects of the COVID-19 pandemic.
2. Characterize the direct and indirect experiences of U4 women with SARS-CoV-2 infection.
3. Identify opportunities for interventions to address maternal mortality in U4 women in the context of an ongoing global pandemic of COVID-19.

Tertiary/Exploratory Objectives:

1. Assess the association between geospatial indicators of exposure and pandemic impacts, including proximity to point sources of environmental pollution, area-level model and monitor-estimated air pollution concentrations, availability of community amenities, and neighborhood structure.
2. Collect baseline data for a future longitudinal cohort study on long-term health impacts of exposure to SARS-CoV-2 (COVID-19) and pandemic experiences among U4 women, as well as to identify risk and protective factors modifying these impacts for developing appropriate interventions for recovery in this population.

3. Pool data with ongoing COVID-19 observational studies to:

   (a) generalize pandemic impacts across multiple U4 populations using pooled meta-analysis; and (b) to understand how U4 status interacts with environmental, health, and social risk factors to produce disparities in pandemic-associated impacts by comparing U4 and non-U4 populations.

4. Understand the distribution and characteristics of exploratory cardiovascular biomarkers among U4 women of reproductive age and their relation to COVID-19 impacts, including SARS-CoV-2 infection and associations with a range of biological, behavioral, environmental, sociocultural, and structural factors impacted by the COVID-19 pandemic that affect pregnancy-related and pregnancy-associated morbidity and mortality.

Endpoints:

Primary. Characterization of mental health, physical health and socioeconomic impacts during and following the pandemic.

Secondary. Primary endpoints plus direct and indirect experiences with SARS-CoV-2 infection.

Tertiary/Exploratory.

1. Geospatial analyses

   1. Direct and indirect experiences with SARS-CoV-2 infection described above.
   2. Worsening of primary endpoints described above.

2. Longitudinal baseline

   1. History of chronic illness
   2. Interest in clinical research participation and acceptable methods
   3. Biological specimens (i.e., urinary cortisol; blood for SARS-CoV-2 antibody testing, cytokine profiling, reproductive endpoints; and blood and saliva for DNA methylation microarrays, toenail clippings for exposure)
   4. Personal exposure (i.e., home dust assays, personal exposure monitoring (wristband), toenail samples).
   5. First time point for repeated longitudinal stress and mental health assessments.

3. Meta-analysis

   1. Environmental, health, and social risk factors
   2. Pandemic-associated impacts

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Jaslyn A Grullon; Phone Number: (984) 287-4999; Email: jaslyn.grullon@nih.gov
• Study Contact Backup: Name: Joan P Packenham, Ph.D.; Phone Number: (919) 541-0766; Email: packenhm@niehs.nih.gov

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • Recruiting
      • NIEHS Clinical Research Unit (CRU)
      • Contact: Jaslyn Grullon; Phone Number: 984-287-4999; Email: jaslyn.grullon@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

• INCLUSION CRITERIA:

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

1. Females who are African American or Black, Hispanic or Latino, American Indian or Alaska Native, Asian American, Native Hawaiian or other Pacific Islander.
2. Aged 18 years or older.
3. Reside in North Carolina.
4. Be willing to provide photo ID
5. Able to read and understand English in order to complete surveys (questions validated in English) and logs.

EXCLUSION CRITERIA:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
U4 Women; Women in under-served, under-studied, under-represented, and under-reported (U4) populations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify cross-sectional associations between retrospective pre-pandemic indicators of U4 status and related exposures	(1) Quantify cross-sectional associations between retrospective pre-pandemic indicators of U4 status and related exposures (i.e., urban vs. rural; pre-existing physical and mental health disparities; risk factors for maternal mortality; experiences of racism; social factors, and environmental, occupational, and housing exposures) with adverse mental, physical, and SES effects of the COVID-19 pandemic. (2) Characterize the direct and indirect experiences of U4 women with SARS-CoV-2 infection. (3) Identify opportunities for interventions to address maternal mortality in U4 women in the context of an ongoing global pandemic of COVID-19.	2 years

Collaborators and Investigators

• Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Joan P Packenham, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 24, 2026

More Information

Terms related to this study

• Keywords: Natural History; COVID-19; Vaccination; Disparities
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Behavior; Personal Satisfaction; COVID-19; Psychological Well-Being
• Other Study ID Numbers: 10000441 (Translational Science Center); 000441-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No