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Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study (BRAVE)

Primary Purpose

Covid19 Virus Infection

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Protect Your Elders Campaign

About this trial

This is an interventional screening trial for Covid19 Virus Infection focused on measuring COVID-19 testing

Eligibility Criteria

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

Inclusion Criteria:

- Self reports as Native American or American Indian

Exclusion Criteria:

Does not self-report as Native American or American Indian

Sites / Locations

Lumbee Tribe Tribal Housing ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

BRAVE Non-Intervention

BRAVE Intervention

Arm Description

Survey participants in the BRAVE non-intervention arm will not have received information (e.g., informational pamplets, flyers, townhalls) about COVID-19 testing and vaccination from the BRAVE project.

Survey participants in the BRAVE intervention arm will have received information (e.g., informational pamplets, flyers, townhalls) about COVID-19 testing and vaccination from the BRAVE project.

Outcomes

Primary Outcome Measures

Increase in COVID-19 testing

Survey responses to determine if participants in zipcodes selected for intervention are more less inclined to get tested for COVID-19.

Increase in COVID-19 vaccination

Survey responses to determine if participants in zipcodes selected for intervention are more less inclined to get vaccinated against COVID-19.

Secondary Outcome Measures

Full Information

NCT ID

NCT04964154

First Posted

July 13, 2021

Last Updated

July 13, 2021

Sponsor

North Carolina Central University

Collaborators

Lumbee Tribe of North Carolina, University of North Carolina at Pembroke

1. Study Identification

Unique Protocol Identification Number

NCT04964154

Brief Title

Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study

Acronym

BRAVE

Official Title

Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 17, 2021 (Actual)

Primary Completion Date

March 30, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

North Carolina Central University

Collaborators

Lumbee Tribe of North Carolina, University of North Carolina at Pembroke

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The Building Resilience and Vital Equity (BRAVE) project seeks to partner with American Indian tribal communities in North Carolina to establish COVID-19 services and resources for American Indian communities. The goal of this study is to 1) understand the barriers and social implications of COVID19 testing and vaccination among American Indians by designing and implementing culturally sensitive survey tools and intervention materials; 2) Implement BRAVE outreach and testing interventions to increase testing in American Indian communities; 3) analyze data and share back with tribal communities to improve perceptions of COVID-19 testing in the AI community and decrease in vaccine hesitancy.

6. Conditions and Keywords

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

Covid19 Virus Infection

Keywords

COVID-19 testing

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomized to receive information about testing and vaccination based on zip code.

Masking

None (Open Label)

Masking Description

No masking employed in this study.

Allocation

Randomized

Enrollment

4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BRAVE Non-Intervention

Arm Type

No Intervention

Arm Description

Arm Title

BRAVE Intervention

Arm Type

Active Comparator

Arm Description

Survey participants in the BRAVE intervention arm will have received information (e.g., informational pamplets, flyers, townhalls) about COVID-19 testing and vaccination from the BRAVE project.

Intervention Type

Behavioral

Intervention Name(s)

Protect Your Elders Campaign

Intervention Description

This is a behavioral intervention where participants will receive cultural appropriate educational information about COVID-19 testing and vaccination.

Primary Outcome Measure Information:

Title

Increase in COVID-19 testing

Description

Survey responses to determine if participants in zipcodes selected for intervention are more less inclined to get tested for COVID-19.

Time Frame

1 month

Title

Increase in COVID-19 vaccination

Description

Survey responses to determine if participants in zipcodes selected for intervention are more less inclined to get vaccinated against COVID-19.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Self reports as Native American or American Indian Exclusion Criteria: Does not self-report as Native American or American Indian

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Deepak Kumar, PhD

Phone

919-530-7017

dkumar@ad.nccu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tracie Locklear

Phone

9195306251

tlockl12@nccu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deepak Kumar, PhD

Organizational Affiliation

North Carolina Central University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lumbee Tribe Tribal Housing Complex

City

Pembroke

State/Province

North Carolina

ZIP/Postal Code

28372

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick Strickland

Phone

910-734-8264

pstrickland@lumbeetribe.com

12. IPD Sharing Statement

Learn more about this trial

Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study

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