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Partnerships to Address COVID-19 Inequities

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Crowdsourced campaign package
Standard information
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • specific zip codes in North Carolina (specific zip codes to be determined)
  • no self-reported history of COVID-19 infection
  • have not tested within the past 14 days

Exclusion Criteria:

  • live outside of study area
  • under 18

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Crowdsourced campaign package

    Standard information

    Arm Description

    The intervention will be developed through a crowdsourcing process, including an open call for submissions.

    The control will be the provision of standard information (e.g., view standard informational videos promoting the adoption of health-protective behaviors and COVID-19 testing).

    Outcomes

    Primary Outcome Measures

    Number of participants enrolled as measured by enrollment log
    Number of participants enrolled as measured by enrollment log
    Number of participants rating intervention as acceptable as measured by a post-intervention questionnaire
    Number of participants rating intervention as acceptable as measured by a post-intervention questionnaire
    Change in the number of participants engaging in 1 or more of the 3 Ws as measured by participant report
    The 3Ws are defined as (1) Wearing a mask, (2) Waiting 6 feet apart, and (3) Washing your hands.
    Change in number of participants who stated that they would self-test for COVID-19 as measured by interview
    Change in number of participants who stated that they would self-test for COVID-19 as measured by interview

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2021
    Last Updated
    September 27, 2023
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05123729
    Brief Title
    Partnerships to Address COVID-19 Inequities
    Official Title
    Community-Academic Partnerships to Address COVID-19 Inequities Within African American Communities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2024 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the impact of an intervention to increase COVID-19 prevention behaviors, including COVID-19 testing. The intervention will be developed through a crowdsourcing contest.
    Detailed Description
    a. The surge of COVID-19 cases has been accompanied by glaring racial disparities in COVID-19-related morbidity and mortality; disparities in outcomes have been most pronounced for African Americans who, despite comprising only 13% of the US population account for about 30% of all COVID-19 cases in states for which race-related data are reported. Infectious disease modelers, epidemiologists, and other public health experts believe that COVID-19 is here to stay and suggest that annual surges may persist through 2025 and beyond. With vaccine hesitancy and delay compromising our ability to attain herd immunity, the best means for controlling the spread of COVID-19 according to public health experts is mass adoption of the 3 Ws (Wear a mask, Wait 6 feet apart, and Wash your hands) and increasing awareness of one's status through testing. As such, non-pharmaceutical interventions (NPIs) are currently our best options for viral control and containment. NPIs that are community-driven and developed in collaboration with diverse partners, including community members, public health agencies, and researchers may offer an acceptable and effective approach to reducing COVID-19 transmission and addressing individual and socio-structural barriers that lead to worse COVID-19-related outcomes among African Americans. Our study goals are to use a crowdsourcing open call to identify exceptional ideas (e.g., messages, videos, communication and dissemination strategies) that promote COVID-19 testing and encourage the public to practice the 3 Ws, referred to as health-promotive behaviors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Crowdsourced campaign package
    Arm Type
    Experimental
    Arm Description
    The intervention will be developed through a crowdsourcing process, including an open call for submissions.
    Arm Title
    Standard information
    Arm Type
    Active Comparator
    Arm Description
    The control will be the provision of standard information (e.g., view standard informational videos promoting the adoption of health-protective behaviors and COVID-19 testing).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Crowdsourced campaign package
    Intervention Description
    COVID-19 prevention intervention developed using a crowdsourcing process.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard information
    Intervention Description
    Standard informational videos promoting the adoption of health-protective behaviors and COVID-19 testing
    Primary Outcome Measure Information:
    Title
    Number of participants enrolled as measured by enrollment log
    Description
    Number of participants enrolled as measured by enrollment log
    Time Frame
    Up to 3 years
    Title
    Number of participants rating intervention as acceptable as measured by a post-intervention questionnaire
    Description
    Number of participants rating intervention as acceptable as measured by a post-intervention questionnaire
    Time Frame
    Up to 4 years
    Title
    Change in the number of participants engaging in 1 or more of the 3 Ws as measured by participant report
    Description
    The 3Ws are defined as (1) Wearing a mask, (2) Waiting 6 feet apart, and (3) Washing your hands.
    Time Frame
    up to 3 years; up to 38 months; up to 40 months
    Title
    Change in number of participants who stated that they would self-test for COVID-19 as measured by interview
    Description
    Change in number of participants who stated that they would self-test for COVID-19 as measured by interview
    Time Frame
    up to 3 years; up to 38 months; up to 40 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: specific zip codes in North Carolina (specific zip codes to be determined) no self-reported history of COVID-19 infection have not tested within the past 14 days Exclusion Criteria: live outside of study area under 18
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tiarney Ritchwood, PhD
    Phone
    336-713-4238
    Email
    tritchwo@wakehealth.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tiarney Ritchwood, PhD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Partnerships to Address COVID-19 Inequities

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