Mental HealthNCT04983251
Women s Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH)
An observational study of Mental Health, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 30 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
Jaslyn Grullon, 984-287-4999, jaslyn.grullon@nih.gov
About this study
Official title: Women's Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH)
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.
Read more
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.
Read the 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:
- 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.
- Determine whether there was a worsening of mental, physical, and socio-economic status before, during, and following the COVID-19 pandemic.
- Characterize the biological, behavioral, environmental, sociocultural, and structural impacts of the COVID-19 pandemic on reproductive risk factors among U4 women.
Secondary Objectives:
- 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.
- Characterize the direct and indirect experiences of U4 women with SARS-CoV-2 infection.
- 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:
- 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.
- 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.
- 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.
- 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.
- Geospatial analyses
- Direct and indirect experiences with SARS-CoV-2 infection described above.
- Worsening of primary endpoints described above.
- Longitudinal baseline
- History of chronic illness
- Interest in clinical research participation and acceptable methods
- 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)
- Personal exposure (i.e., home dust assays, personal exposure monitoring (wristband), toenail samples).
- First time point for repeated longitudinal stress and mental health assessments.
- Meta-analysis
- Environmental, health, and social risk factors
- Pandemic-associated impacts
- Conditions
- Mental Health
- Keywords
- Disparities, Vaccination, COVID-19, Natural History
- Medical subject headings
- Psychological Well-Being, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| U4 Women | Women in under-served, under-studied, under-represented, and under-reported (U4) populations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start30 Jun 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joan P Packenham, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983251
- Sponsor's protocol ID
- 10000441
- Other IDs
- 000441-E
- Status last verified
- 21 Oct 2026
- First submitted
- 29 Jul 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided