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

July 13, 2021 updated by: Deepak Kumar, North Carolina Central University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Pembroke, North Carolina, United States, 28372
        • Recruiting
        • Lumbee Tribe Tribal Housing Complex
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Self reports as Native American or American Indian

Exclusion Criteria:

  • Does not self-report as Native American or American Indian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: BRAVE Non-Intervention
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.
Active Comparator: BRAVE Intervention
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.
Behavioral: Protect Your Elders Campaign
This is a behavioral intervention where participants will receive cultural appropriate educational information about COVID-19 testing and vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in COVID-19 testing
Time Frame: 1 month
Survey responses to determine if participants in zipcodes selected for intervention are more less inclined to get tested for COVID-19.
1 month
Increase in COVID-19 vaccination
Time Frame: 1 month
Survey responses to determine if participants in zipcodes selected for intervention are more less inclined to get vaccinated against COVID-19.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Carolina Central University

Collaborators

Lumbee Tribe of North Carolina
University of North Carolina at Pembroke

Investigators

  • Principal Investigator: Deepak Kumar, PhD, North Carolina Central University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2021

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1201571

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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