NCT04731870

Brief Summary

The COVID-19 pandemic has highlighted deleterious US health inequities. Specifically, African Americans, Latinos, and Native Americans have and continue to shoulder a greater burden of COVID-19 infections and deaths in the US. In addition to existing racial and ethnic disparities are rural health and regional disparities. Given the disproportionate impact of disease in US communities of color and also in rural and southern regions of the US, there is no doubt that these at-risk subgroups will continue to experience higher rates of coronavirus-related mortality as well as other long-term health outcomes as compared to other US populations. It is unknown how healthcare providers and other key at-risk subgroups within the US will receive COVID-19 vaccines. For success in immunizations, the US will need to reach their most at-risk and vulnerable populations. In addition to at-risk populations, a successful immunization strategy will involve engaging providers to support clear, consistent, and strong vaccine recommendation. It is critical to build vaccine trust, confidence, and overall acceptance of COVID-19 vaccines among healthcare providers and key at-risk subgroups, especially given the accelerated production timeline of these vaccines. Likewise, tailored vaccine messaging for key subgroups is vital in achieving vaccine confidence and trust. The proposed study will explore perceptions, confidence, trust, and uptake of potential COVID-19 vaccines among healthcare providers (nurses and doctors) and key at-risk population subgroups (minority populations living in the rural south) and will develop and test vaccine messaging that boosts vaccine confidence and trust among these key at-risk subgroups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

February 28, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

January 27, 2021

Last Update Submit

July 25, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Covid-19 vaccine confidence (survey to be developed by study team)

    Confidence in the Covid-19 vaccine efficacy and safety among a cross-section of healthcare providers and key at-risk subgroups in the US

    year 1

  • Covid-19 vaccine messaging (messages to be developed by study team & focus group participants)

    COVID-19 vaccine messaging (e.g. one or two sentences of culturally appropriate messages) that can be used to boost vaccine confidence and trust, and COVID-19 preventive behavior, among at-risk subgroups in the US (minority populations living in the rural south).

    year 2

  • Covid-19 vaccine uptake (survey to be developed by study team)

    COVID-19 vaccine uptake or projected uptake among a cross-section of healthcare providers and key at-risk subgroups in the US

    year 1

  • Covid-19 vaccine trust (survey to be developed by study team)

    COVID-19 vaccine trust in the health system and public health authorities a cross-section of healthcare providers and key at-risk subgroups in the US

    year 1

  • Covid-19 vaccine recommendation practices (survey to be developed by study team)

    COVID-19 vaccine recommendation practices among a cross-section of healthcare providers in the US

    year 1

Study Arms (2)

Nurses/Doctors

Covid-19 vaccine confidence and recommendation practices of nurses/doctors

Other: Survey research

Minority populations living in rural south

Covid-19 vaccine confidence and uptake of key at-risk subgroups and tailored Covid-10 vaccine messaging for at-risk subgroups.

Other: Survey research

Interventions

This is not an intervention study. It involves social science research of surveys and focus groups.

Minority populations living in rural southNurses/Doctors

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Objectives 1 and 2 will be met by administering an electronic quantitative survey among the following four distinct groups: 1) Nurses (at least 50% from the south), 2) Primary Care/Family Physicians (at least 50% from the south), 3) Rural, low-income, minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American) and 4) Urban, low-income minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American). Each group will contain at least 150 subjects for a total of 600 participants.

You may qualify if:

  • Nurses (at least 50% from the south),
  • Primary Care/Family Physicians (at least 50% from the south),
  • Rural, low-income, minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American) and
  • Urban, low-income minority men and women living in the south (income of $25K per year or less and 70% of respondents will be Black, Latina, or Native American).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carol Belk Building

Greenville, North Carolina, 27858, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Becky Welch, CPA

    Assistant Vice Chancellor for Research Administration & Finance

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 1, 2021

Study Start

February 28, 2021

Primary Completion

January 1, 2023

Study Completion

March 31, 2023

Last Updated

July 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations