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

Sponsor
National Institute of Environmental Health Sciences (NIEHS) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04983251
Collaborator
(none)
700
1
11
63.4

Study Details

Study Description

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.

Design:

Participants will be screened with a 1-hour 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 give a blood sample.

Participants may give saliva samples. They will be asked to give 5 samples on 2 different days during a 1-week period. They will fill out a log with each sample they collect.

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.

Condition or Disease Intervention/Treatment Phase

    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 under-reported (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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Women's Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH) Equity
    Anticipated Study Start Date :
    Aug 30, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    U3 Women

    Women in under-studied, under-represented, and under-reported (U3) populations.

    Outcome Measures

    Primary Outcome Measures

    1. Characterize the mental, physical, and socio-economic effects [2 years]

      (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.

    Secondary Outcome Measures

    1. Quantify cross-sectional associations between retrospective pre-pandemic indicators of U3 status and related exposures [2 years]

      (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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:

    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, Hispanics or Latinos, American Indians or Alaska Natives, Asian Americans, Native Hawaiian or other Pacific Islander.

    • Aged 18 years or older.

    • Reside in North Carolina.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NIEHS Clinical Research Unit (CRU) Research Triangle Park North Carolina United States 27709

    Sponsors and Collaborators

    • National Institute of Environmental Health Sciences (NIEHS)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Environmental Health Sciences (NIEHS)
    ClinicalTrials.gov Identifier:
    NCT04983251
    Other Study ID Numbers:
    • 10000441
    • 000441-E
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 10, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Environmental Health Sciences (NIEHS)

    Study Results

    No Results Posted as of Aug 25, 2022