NCT04964154

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

July 13, 2021

Last Update Submit

July 13, 2021

Conditions

Keywords

COVID-19 testing

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 month

  • 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.

    1 month

Study Arms (2)

BRAVE Non-Intervention

NO 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.

BRAVE Intervention

ACTIVE COMPARATOR

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

Interventions

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

BRAVE Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Self reports as Native American or American Indian

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lumbee Tribe Tribal Housing Complex

Pembroke, North Carolina, 28372, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Deepak Kumar, PhD

    North Carolina Central University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepak Kumar, PhD

CONTACT

Tracie Locklear

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking employed in this study.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive information about testing and vaccination based on zip code.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Julius L. Chambers Biomedical/Biotechnology Research Institute

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 15, 2021

Study Start

February 17, 2021

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations