Clinical trial NCT04703790: Acceptability of a COVID-19 Vaccine Among US Adults Over Two Time Periods
Official title: Acceptability Across Two Time Periods of a SARS-CoV-2 Vaccine Among a Representative Sample of Adults Within the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Vaccine Acceptability
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-01-11
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults 18 years of age and older, who live in the US and who have been recruited to be members of Ipsos (KnowledgePanel) survey research panel.

Brief summary: The overall purpose of this study is to address the factors associated with an individual's personal willingness to get the vaccine and attitudes about potential public policy approaches to implementation of a Coronavirus Disease 2019 (COVID-19) vaccine. Additionally, to evaluate how these attitudes change over time. The 1200 participants will be recruited by Ipsos (Ipsos KnowledgePanel®) from their nationally representative panel to participate in a survey at Time 1 and 1 year later. The information collected will include demographics, health status, household composition, experiences with COVID-19, attitudes about vaccines in general, COVID-19 vaccine specific attitudes, willingness to get a COVID-19 vaccine acceptability, and attitudes regarding COVID-19 vaccine mandates. The investigators anticipate that those who live in urban areas and who are older, have greater knowledge of COVID-19, who have known someone who was hospitalized for COVID-19, and have generally positive attitudes about vaccines will be more willing to get a vaccine. The primary reasons for willingness will be personal safety and desire to return to normal activities. The investigators also anticipate that those who vary on socio-demographics (e.g., live in urban areas, have more liberal political views), have greater knowledge of COVID-19, who have known someone who was hospitalized for COVID- 19, and have generally positive attitudes about vaccines will be more supportive of mandatory vaccination strategies. The investigators anticipate that attitudes will change over time in response to the current status of the pandemic and of available data about the vaccine's efficacy and safety.

Detailed description: The overall objective is to address attitudes about potential public policy approaches to implementation of a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccine and the factors associated with an individual's personal willingness to get the vaccine once available, and to assess how these attitudes change over time.

First specific aim:

1a. To describe participants' perceptions of public health strategies including mandatory vaccination requirements (e.g., travel, school attendance, work place requirements (e.g., schools, health care facilities, offices), working in a health care facility, health care providers, living in residential facilities) and targeted age groups (e.g., children, adolescents, adults, elderly).

1. b. To determine how attitudes about strategies are related to socio-demographic characteristics (e.g., age, education, race/ethnicity, political views and political party affiliation, household structure), knowledge of SARS-CoV-2, personal experience with the infection, and other vaccine attitudes.

   Example hypothesis: Those who vary on socio-demographics (e.g., live in urban areas, have more liberal political views), have greater knowledge of SARS-CoV-2, who have known someone who was hospitalized for SARS-CoV-2, and have generally positive attitudes about vaccines will be more supportive of mandatory vaccination strategies.

   Second specific aim:
2. a. To determine the relationship of socio-demographic characteristics (e.g., age, education, race/ethnicity, political views and political party affiliation, household structure), knowledge of SARS-CoV-2, personal experience with the infection, and other vaccine attitudes with willingness to get the vaccine.

2b. To evaluate the primary reasons driving vaccine acceptance including safety issues (personal, family, or global), desire to return to normal activities (e.g., school, work, or social events), and desire to no longer need to wear a mask.

Example hypotheses: Those who vary on socio-demographic characteristics (e.g., live in urban areas, who are older), have greater knowledge of SARS-CoV-2, who have known someone who was hospitalized for SARS-CoV-2, and have generally positive attitudes about vaccines will be more willing to get a vaccine. The primary reasons for willingness will be personal safety and desire to return to normal activities.

Third specific aim: This specific aim focuses on how the findings from aim 1 and aim 2 change over time.

3a. To evaluate how national level perceptions of public health strategies (aim 1) and an individual's personal willingness to get the vaccine (aim 2) change over time.

Given the unknown trajectory, there are several possible scenarios. For example, if nationally there is a decrease in new infections with lifting of the restrictions then the investigators hypothesize that there will be an overall decrease in support for mandatory strategies and in willingness to accept the vaccine. Alternatively, if new infections are rising and restrictions are in place, then there will be an overall increase in acceptability. The investigators are also prepared to adapt our surveys should one or more vaccines become licensed and available prior to the time 1 or time 2 survey.

3b. The investigators will explore whether changes in perceptions of public health strategies (aim 1) and an individual's personal willingness to get the vaccine (aim 2) vary based on relevant socio-demographic characteristics (e.g., region of the country, political views and political party affiliation, household structure, race/ethnicity) and, when appropriate, changes within those characteristics (e.g., when rates of infections are changing differentially across regions). The investigators also will explore whether changes in perceptions of public health strategies (aim 1) and an individual's personal willingness to get the vaccine (aim 2) vary based on perceptions of societal events. For example, the investigators will evaluate if changes in vaccine attitudes are associated with regional differences in whether cases are increasing or decreasing; changes in household structure (e.g., the presence of elders in the home); or perceptions of media reports.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Able to read English and Spanish
* Panelists with Ipsos (KnowledgePanel)

Exclusion Criteria:

* 17 years of age and younger
* Not able to read English or Spanish
* Not a member of Ipsos (KnowledgePanel)

Primary outcomes:
measure: Vaccination or intention to get vaccinated for COVID-19
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Attitudes toward mandates for COVID-19 vaccines
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Susan L Rosenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References: