Covid19NCT04801030
COVID-19 Vaccine Hesitancy Among African Americans
A study testing YourCoViDVaxFacts in people with Covid19 and Vaccine Refusal, run by Meharry Medical College at 1 site in United States.
Trial summary
Coronavirus disease 2019 (COVID-19) has created a "state of emergency" for African Americans in the US. Recent findings indicate 31% of adults self-reported "wait and see" of the COVID-19 vaccine, of which 16% were African American. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Vaccine Refusal, Communication
- What is being tested?
- YourCoViDVaxFacts
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 30 Sep 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
- African American
- Unvaccinated for COVID-19
- Vaccine hesitant
- 18 years and older
- Speaks English
Who cannot join
- Not African American
- Receipt of COVID-19 vaccination
- under 18 years of age
- Does not speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Multi-strategies to Address COVID-19 Vaccine Hesitancy Among African Americans
Coronavirus disease 2019 (COVID-19) has created a "state of emergency" for African Americans in the US. Recent findings indicate 31% of adults self-reported "wait and see" of the COVID-19 vaccine, of which 16% were African American. This project seeks to test the feasibility and impact of a multi-layered, culturally-appropriate social marketing intervention targeting COVID-19 vaccine hesitant (VH) African Americans to increase vaccine confidence, uptake, and completion of multi-dose vaccine series in Nashville/Davidson County, Tennessee. This study's novelty lies in being the first to assess feasibility and preliminary efficacy of a multi-layered, culturally-appropriate social marketing intervention to promote COVID-19 vaccination among African Americans in TN. Clinical significance is increased vaccine uptake and decreased COVID-19 burden and disparities.
Read the detailed description
The goal of this application is to develop and test the feasibility and impact of a multi-layered, culturally-appropriate social marketing intervention targeting COVID-19 VH African Americans to increase uptake and completion of vaccine series in Nashville/Davidson County, Tennessee (TN). Investigators will partner with members of National Association for the Advancement of Colored People, Nashville Health Disparities Coalition, and Congregational Health Education Network to serve as an advisory committee. Investigators will also partner with Meharry Medical College (MMC) clinics and Tennessee Department of Health's (TDH) Immunization Program.
Aim 1. Engage with key stakeholders to develop a multi-layered, culturally-appropriate social marketing intervention targeting African Americans who are COVID-19 VH. Investigators will adapt an existing message library using the Health Belief Model,Theory of Reasoned Action, previous VH research, preliminary data of investigators, and feedback from community partners. Next, investigators will conduct semi-structured interviews with 25-30 VH individuals and 5-10 COVID-19 experts to elicit feedback on draft content. Qualitative data will be collected and analyzed iteratively, informing successive intervention modifications to cover a range of concerns for VH individuals, enhance message relevance, and determine media outlets for dissemination. Next, investigators will pre-test intervention prototypes with 16 COVID-19 VH individuals to make final modifications.
Aim 2a. Conduct a pilot study of the intervention and study protocol to demonstrate feasibility and assess impact. Investigators will conduct a pilot study using an experimental field trial design in three TN counties: Davidson County (1 intervention site) and Shelby and Hamilton Counties (2 control sites). COVID-19 vaccine uptake, primary outcome, assessed using: 1) aggregate data from partner clinics and TN immunization registry (TennIIS) and 2) individual, pre-post data from a marketing firm using random digit dialing (RDD). H1: COVID-19 vaccination rates will be higher for VH African Americans at intervention site compared to control sites. Implementation outcomes are feasibility, fidelity, acceptability, appropriateness, and penetration.
Aim 2b. To retrospectively explore knowledge, attitudes, intentions, and implementation outcomes post-intervention. Investigators will use qualitative methods to identify perceived acceptance of different types of media and webpage along with perceived change in knowledge, attitudes, and intentions from African Americans by degree of VH. Investigators will also explore appropriateness, feasibility, penetration, and fidelity as it relates to the social marketing intervention from 3 providers, 3 community-based organization (CBO) staff, and 2 TDH staff. Participants will be identified using RDD and community partner networks.
- Conditions
- Covid19, Vaccine Refusal, Communication
- Being tested
- YourCoViDVaxFacts
- Medical subject headings
- COVID-19, Vaccination Refusal, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YourCoViDVaxFactsBehavioural
The intervention will be delivered via multiple strategies- social media (YouTube, Facebook), radio, newspaper, tv ads, community partner networks. Participants receive culturally-tailored message on COVID-19 and the vaccine. The strategies will have a link that will open to a website that is optimized for viewing on a computer or mobile phone which has the look and feel of an app, but without requiring the user to download anything to the phone. On the website, participants will be prompted to select their top concerns from a list. Based on the responses, the top barriers or need will each be mapped to a corresponding educational message, which will be displayed to the user with appropriate images or graphics.
| Study group | Role | What they receive |
|---|---|---|
| Culturally-appropriate social marketing campaign | Experimental | Participants will receive a multi-layered, social marketing campaign which is deemed culturally appropriate. This will occur over a 6 month -time period. Rates will be observed at 0, 6, and 12 months. Receives: Behavioral: YourCoViDVaxFacts |
| Control Arm 1 | No intervention | Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months. |
| Control Arm 2 | No intervention | Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
percent enrolled in study
Measured: 6 months
Retention rates
percent completed baseline survey, percent completed follow-up survey
Measured: 1 year
data collection processes
percent ascertained COVID 19 vaccine status post-intervention
Measured: 1 year
Secondary outcomes (2)
COVID-19 vaccine rates
Number of individuals vaccinated post-intervention
Measured: 6 months
Attitudes toward COVID-19 vaccine
Change in attitudes toward COVID-19 vaccine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start20 May 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- St. Jude Children's Research Hospital
- Responsible party
- Sponsor
- Investigators
- Jennifer C Erves, PhD, Principal investigator, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801030
- Sponsor's protocol ID
- 21-03-1076
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Multi-strategies to Address COVID-19 Vaccine Hesitancy Among African Americans
- ClinicalTrials.gov ID
- NCT04801030
- Acronym / sponsor ID
- 21-03-1076
- Conditions
- Covid19, Vaccine Refusal, Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- St. Jude Children's Research Hospital
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Mar 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.
Coronavirus disease 2019 (COVID-19) has created a "state of emergency" for African Americans in the US. Recent findings indicate 31% of adults self-reported "wait and see" of the COVID-19 vaccine, of which 16% were African American. This project seeks to test the feasibility and impact of a multi-layered, culturally-appropriate social marketing intervention targeting COVID-19 vaccine hesitant (VH) African Americans to increase vaccine confidence, uptake, and completion of multi-dose vaccine series in Nashville/Davidson County, Tennessee. This study's novelty lies in being the first to assess feasibility and preliminary efficacy of a multi-layered, culturally-appropriate social marketing intervention to promote COVID-19 vaccination among African Americans in TN. Clinical significance is increased vaccine uptake and decreased COVID-19 burden and disparities.
Detailed description
The goal of this application is to develop and test the feasibility and impact of a multi-layered, culturally-appropriate social marketing intervention targeting COVID-19 VH African Americans to increase uptake and completion of vaccine series in Nashville/Davidson County, Tennessee (TN). Investigators will partner with members of National Association for the Advancement of Colored People, Nashville Health Disparities Coalition, and Congregational Health Education Network to serve as an advisory committee. Investigators will also partner with Meharry Medical College (MMC) clinics and Tennessee Department of Health's (TDH) Immunization Program.
Aim 1. Engage with key stakeholders to develop a multi-layered, culturally-appropriate social marketing intervention targeting African Americans who are COVID-19 VH. Investigators will adapt an existing message library using the Health Belief Model,Theory of Reasoned Action, previous VH research, preliminary data of investigators, and feedback from community partners. Next, investigators will conduct semi-structured interviews with 25-30 VH individuals and 5-10 COVID-19 experts to elicit feedback on draft content. Qualitative data will be collected and analyzed iteratively, informing successive intervention modifications to cover a range of concerns for VH individuals, enhance message relevance, and determine media outlets for dissemination. Next, investigators will pre-test intervention prototypes with 16 COVID-19 VH individuals to make final modifications.
Aim 2a. Conduct a pilot study of the intervention and study protocol to demonstrate feasibility and assess impact. Investigators will conduct a pilot study using an experimental field trial design in three TN counties: Davidson County (1 intervention site) and Shelby and Hamilton Counties (2 control sites). COVID-19 vaccine uptake, primary outcome, assessed using: 1) aggregate data from partner clinics and TN immunization registry (TennIIS) and 2) individual, pre-post data from a marketing firm using random digit dialing (RDD). H1: COVID-19 vaccination rates will be higher for VH African Americans at intervention site compared to control sites. Implementation outcomes are feasibility, fidelity, acceptability, appropriateness, and penetration.
Aim 2b. To retrospectively explore knowledge, attitudes, intentions, and implementation outcomes post-intervention. Investigators will use qualitative methods to identify perceived acceptance of different types of media and webpage along with perceived change in knowledge, attitudes, and intentions from African Americans by degree of VH. Investigators will also explore appropriateness, feasibility, penetration, and fidelity as it relates to the social marketing intervention from 3 providers, 3 community-based organization (CBO) staff, and 2 TDH staff. Participants will be identified using RDD and community partner networks.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Culturally-appropriate social marketing campaign | Experimental | Behavioral: YourCoViDVaxFactsParticipants will receive a multi-layered, social marketing campaign which is deemed culturally appropriate. This will occur over a 6 month -time period. Rates will be observed at 0, 6, and 12 months. |
| Control Arm 1 | No intervention | –Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months. |
| Control Arm 2 | No intervention | –Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- African American
- Unvaccinated for COVID-19
- Vaccine hesitant
- 18 years and older
- Speaks English
Key exclusion criteria (4 listed)
- Not African American
- Receipt of COVID-19 vaccination
- under 18 years of age
- Does not speak English
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 |
|---|---|---|
| YourCoViDVaxFactsThe intervention will be delivered via multiple strategies- social media (YouTube, Facebook), radio, newspaper, tv ads, community partner networks. Participants receive culturally-tailored message on COVID-19 and the vaccine. The strategies will have a link that will open to a website that is optimized for viewing on a computer or mobile phone which has the look and feel of an app, but without requiring the user to download anything to the phone. On the website, participants will be prompted to select their top concerns from a list. Based on the responses, the top barriers or need will each be mapped to a corresponding educational message, which will be displayed to the user with appropriate images or graphics. | Behavioural | Culturally-appropriate social marketing campaign |
Primary outcome
Recruitment rates
Time frame: 6 months
percent enrolled in study
Retention rates
Time frame: 1 year
percent completed baseline survey, percent completed follow-up survey
data collection processes
Time frame: 1 year
percent ascertained COVID 19 vaccine status post-intervention
2 secondary outcomes
COVID-19 vaccine rates
Time frame: 6 months
Attitudes toward COVID-19 vaccine
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Jennifer C Erves, PhD principal investigator
Meharry Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YourCoViDVaxFacts in people with Covid19 and Vaccine Refusal, run by Meharry Medical College 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 5 inclusion and 4 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 18 Apr 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: 6 months). The study lists 3 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 18 Apr 2022.