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
About this trial
This is an interventional prevention trial for COVID-19
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
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
NCT ID
NCT05123729
First Posted
November 15, 2021
Last Updated
September 27, 2023
Sponsor
Wake Forest University Health Sciences
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
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Partnerships to Address COVID-19 Inequities
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