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 ofstudies have assessed the impact of individual risk factors. But few studies haveassessed which factors are the greatest drivers of COVID-19 disparities from a widerperspective.Objective:To understand the long-term impacts of COVID-19 on minority women and their families toassist 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 theirdemographics, community, health, lifestyle, household, and environment.Participants may choose to have tests. They may visit the Clinical Research Unit. Theymay also have a home visit for these tests. In some cases, they may mail samples to thestudy 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 theirsample.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 fortesting. They will be asked to swipe a total of 3 door frames. Each door frame should bein a different room of the house.Participants may be given silicone wristbands to wear for 1 week. This is to measuretheir exposure to air pollutants.Participants may be contacted in the future for follow-up. They may be contacted byphone, email, or letter.
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
- 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.
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States
Investigator: Jaslyn Grullon
Contact: 984-287-4999
jaslyn.grullon@nih.gov
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)