Official Title
Women's Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH) Equity
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 urine samples. They will be asked to give 4 samples on 2 consecutive days. They will fill out a log with each sample they collect. Participants may give saliva samples. Participants will give toenail samples from each toe. Participants will 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 will 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.

Detailed 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-studied,
under-represented, and underreported (U3) populations. We hypothesize that U3 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 U3 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 U3 women, as well as identify high impact targets for public health
interventions to build resiliency in U3 communities.

Objectives:

Primary Objectives:

1. Characterize the mental, physical, and socio-economic effects of the COVID-19 pandemic
on women in under-studied, under-represented, and under-reported (U3) 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 U3 women.

Secondary Objectives:

1. Quantify cross-sectional associations between retrospective pre-pandemic indicators of
U3 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 U3 women with SARS-CoV-2 infection.

3. Identify opportunities for interventions to address maternal mortality in U3 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 U3 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 U3 populations using pooled
meta-analysis; and (b) to understand how U3 status interacts with environmental, health,
and social risk factors to produce disparities in pandemic-associated impacts by
comparing U3 and non-U3 populations.

4. Understand the distribution and characteristics of exploratory cardiovascular biomarkers
among U3 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
thataffect 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

Recruiting
Mental Health
Eligibility Criteria

- 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

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.

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States

Investigator: Jaslyn Grullon
Contact: 984-287-4999
jaslyn.grullon@nih.gov

Contacts

Jaslyn A Grullon
(984) 287-4999
jaslyn.grullon@nih.gov

Joan P Packenham, Ph.D.
(919) 541-0766
packenhm@niehs.nih.gov

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

National Institute of Environmental Health Sciences (NIEHS)
NCT Number
Keywords
Disparities
Vaccination
Covid-19
Natural History