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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04731870
Other study ID # 60622
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2021
Est. completion date March 31, 2023

Study information

Verified date March 2023
Source East Carolina University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Study objectives are as follows: Objective 1: To assess COVID-19 perceptions, COVID-19 vaccine confidence, projected vaccine recommendation practices, and trust in the health system and public health authorities among a cross-section of healthcare providers in the US (nurses and physicians); Objective 2: To assess COVID-19 perceptions, COVID-19 vaccine confidence, projected vaccine uptake, and trust in the health system, in healthcare providers, and in public health authorities among key at-risk subgroups in the US (minority populations living in the rural south); and Objective 3: To develop, tailor, and test COVID-19 vaccine messaging 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). Perceptions, confidence, uptake, and trust in potential COVID-19 vaccines will be assessed among four identified and distinct groups via a quantitative and electronic survey and qualitative focus groups with key at-risk subgroups will be utilized to develop, tailor, and test COVID-19 vaccine messaging for at-risk subgroups. This study will: 1) provide important national-level data regarding healthcare provider vaccine perceptions, confidence, trust, and projected vaccine recommendation practices for COVID-19, 2) ascertain vaccine perceptions, confidence, trust, and projected uptake of potential COVID-19 vaccines among at-risk populations in the US, and 3) develop tailored messaging for at-risk populations that can be used to boost vaccine confidence and trust, and preventive behaviors, among these high-risk groups in the coming years. This study will help to inform a larger coordinated national promotion strategy and campaign that can work to effectively communicate with the public about potential COVID-19 vaccines.


Recruitment information / eligibility

Status Completed
Enrollment 632
Est. completion date March 31, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 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). Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Carol Belk Building Greenville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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