Clinical trial NCT04731870: Exploring Vaccine Confidence and Uptake of Potential COVID-19 Vaccines
Official title: Exploring Vaccine Confidence and Uptake of Potential COVID-19 Vaccines Among a Cross-section of US Healthcare Providers and Key At-risk Subgroups in the Rural South
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Covid-19 vaccine confidence (survey to be developed by study team)
timeFrame: year 1
measure: Covid-19 vaccine messaging (messages to be developed by study team & focus group participants)
timeFrame: year 2
measure: Covid-19 vaccine uptake (survey to be developed by study team)
timeFrame: year 1
measure: Covid-19 vaccine trust (survey to be developed by study team)
timeFrame: year 1
measure: Covid-19 vaccine recommendation practices (survey to be developed by study team)
timeFrame: year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Carol Belk Building
state: North Carolina
Study officials:
affiliation: Assistant Vice Chancellor for Research Administration & Finance
name: Becky Welch, CPA
role: STUDY_CHAIR
References: