Covid19 Virus InfectionBRAVENCT04964154
Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study
A study testing Protect Your Elders Campaign in people with Covid19 Virus Infection, run by North Carolina Central University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19 Virus Infection
- What is being tested?
- Protect Your Elders Campaign
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self reports as Native American or American Indian
Who cannot join
- Does not self-report as Native American or American Indian
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lumbee Tribe Tribal Housing Complex
Pembroke, North Carolina, 28372
Patrick Strickland, 910-734-8264, pstrickland@lumbeetribe.com
About this study
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.
- Conditions
- Covid19 Virus Infection
- Being tested
- Protect Your Elders Campaign
- Keywords
- COVID-19 testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protect Your Elders CampaignBehavioural
This is a behavioral intervention where participants will receive cultural appropriate educational information about COVID-19 testing and vaccination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Protect Your Elders Campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start17 Feb 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive information about testing and vaccination based on zip code.
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina Central University
- Sponsor type
- University, hospital or other
- Collaborators
- Lumbee Tribe of North Carolina, University of North Carolina at Pembroke
- Responsible party
- Principal investigator, Deepak Kumar, North Carolina Central University
- Investigators
- Deepak Kumar, PhD, Principal investigator, North Carolina Central University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964154
- Sponsor's protocol ID
- 1201571
- Acronym
- BRAVE
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study
- ClinicalTrials.gov ID
- NCT04964154
- Acronym / sponsor ID
- BRAVE / 1201571
- Conditions
- Covid19 Virus Infection
- Keywords
- COVID-19 testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- North Carolina Central UniversityUniversity, hospital or other
- Collaborators
- Lumbee Tribe of North Carolina, University of North Carolina at Pembroke
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive information about testing and vaccination based on zip code.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Protect Your Elders CampaignSurvey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self reports as Native American or American Indian
Key exclusion criteria (1 listed)
- Does not self-report as Native American or American Indian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protect Your Elders CampaignThis is a behavioral intervention where participants will receive cultural appropriate educational information about COVID-19 testing and vaccination. | Behavioural | BRAVE Intervention |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Kumar, PhD principal investigator
North Carolina Central University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protect Your Elders Campaign in people with Covid19 Virus Infection, run by North Carolina Central University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deepak Kumar, PhD (919-530-7017, dkumar@ad.nccu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in COVID-19 testing (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.