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COVID-19 Vaccine Hesitancy Among African Americans

11 april 2022 uppdaterad av: Meharry Medical College

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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37208
        • Meharry Medical College

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Culturally-appropriate social marketing campaign
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.
Beteende: YourCoViDVaxFacts
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.
Inget ingripande: Control Arm 1
Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.
Inget ingripande: Control Arm 2
Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recruitment rates
Tidsram: 6 months
percent enrolled in study
6 months
Retention rates
Tidsram: 1 year
percent completed baseline survey, percent completed follow-up survey
1 year
data collection processes
Tidsram: 1 year
percent ascertained COVID 19 vaccine status post-intervention
1 year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
COVID-19 vaccine rates
Tidsram: 6 months
Number of individuals vaccinated post-intervention
6 months
Attitudes toward COVID-19 vaccine
Tidsram: 6 months
Change in attitudes toward COVID-19 vaccine
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Meharry Medical College

Samarbetspartners

St. Jude Children's Research Hospital

Utredare

  • Huvudutredare: Jennifer C Erves, PhD, Meharry Medical College

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 maj 2021

Primärt slutförande (Förväntat)

30 september 2022

Avslutad studie (Förväntat)

30 september 2022

Studieregistreringsdatum

Först inskickad

11 mars 2021

Först inskickad som uppfyllde QC-kriterierna

15 mars 2021

Första postat (Faktisk)

16 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 21-03-1076

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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