NCT04801030

Brief 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. 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.

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
300

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started May 2021

Typical duration for not_applicable covid19

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

First Submitted

Initial submission to the registry

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

March 11, 2021

Last Update Submit

April 11, 2022

Conditions

Covid19Vaccine RefusalCommunication

Outcome Measures

Primary Outcomes (3)

  • Recruitment rates

    percent enrolled in study

    6 months

  • Retention rates

    percent completed baseline survey, percent completed follow-up survey

    1 year

  • data collection processes

    percent ascertained COVID 19 vaccine status post-intervention

    1 year

Secondary Outcomes (2)

  • COVID-19 vaccine rates

    6 months

  • Attitudes toward COVID-19 vaccine

    6 months

Study Arms (3)

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.

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.

Interventions

YourCoViDVaxFactsBEHAVIORAL

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.

Culturally-appropriate social marketing campaign

Eligibility Criteria

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

You may qualify if:

  • African American
  • Unvaccinated for COVID-19
  • Vaccine hesitant
  • years and older
  • Speaks English

You may not qualify if:

  • Not African American
  • Receipt of COVID-19 vaccination
  • under 18 years of age
  • Does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

COVID-19Vaccination RefusalCommunication

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jennifer C Erves, PhD

    Meharry Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

May 20, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)