COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease
Primary Purpose
Sickle Cell Disease, COVID-19 Vaccine, Vaccine Hesitancy
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCD-specific COVID-19 vaccination information (SCVI) video
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria: diagnosis of sickle cell disease Exclusion Criteria: unable to read or understand spoken English to complete the survey
Sites / Locations
- Duke Adult Sickle Cell Program
Outcomes
Primary Outcome Measures
Vaccine hesitancy
To assess vaccine hesitancy in patients not vaccinated for COVID-19, we will ask participants "how likely are you to get vaccinated for COVID-19 in the future?". Response options will be dichotomized into not hesitant ("likely or somewhat likely") vs neutral vs hesitant ("somewhat unlikely or not likely"). We will also assess vaccine hesitancy for people
Secondary Outcome Measures
Full Information
NCT ID
NCT05998824
First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
Duke University
Collaborators
American Society of Hematology
1. Study Identification
Unique Protocol Identification Number
NCT05998824
Brief Title
COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease
Official Title
COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 23, 2023 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University
Collaborators
American Society of Hematology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to test an COVID-19 vaccination information video in adults with sickle cell disease. The main questions it aims to answer are why are some adults with sickle cell disease hesitant to receive COVID-19 vaccination and whether a COVID-19 vaccination information video tailored for people with sickle cell disease will reduce vaccine hesitancy. Participants will complete a brief survey before and after watching a short video with information on vaccine safety, efficacy, and the greater impact of COVID-19 infection on people with sickle cell disease.
Detailed Description
In this research study, we seek to gain a better understanding of reasons for COVID-19 vaccine hesitancy in adults with sickle cell disease (SCD). We will develop a SCD-specific COVID-19 vaccination information (SCVI) video that discusses vaccine safety, efficacy, and necessity of COVID-19 vaccination for the sickle cell patient population, and determine if the video reduces vaccine hesitancy in adults with SCD. Hopefully, this will inform future education interventions to improve confidence in COVID-19 vaccines and subsequently increase vaccination rates.
Specifically, the research objectives are:
To determine factors associated with COVID-19 vaccine hesitancy in adults with SCD To determine if a SCD-specific COVID-19 vaccination information (SCVI) video reduces vaccine hesitancy in adults with SCD.
This study will be conducted as a part of an ongoing prospective research study aimed at better understanding COVID-19 vaccine hesitancy at the Duke Adult Comprehensive Sickle Cell Center. Two cross-sectional surveys will be administered to patients seen in the Adult Sickle Cell Clinic and Day Hospital who meet the inclusion criteria. The purpose of the initial survey will be to obtain a baseline vaccination rate and to gain a better understanding behind vaccine hesitancy in this patient population. After completion of the first survey, a short video discussing the safety, efficacy, and importance of the COVID-19 vaccine for patients with sickle cell disease will be watched prior to completing the second survey. The video will be available via scanning a QR code or via direct link if the survey is filled out electronically. Members of the Community Advisory Board for the Duke Sickle Cell Program will be interviewed in a group to gain an understanding of how to improve and implement the assessment in practice (non-research activity). A subsequent "post-intervention" survey will then administered to determine if the SCVI video reduces vaccine hesitancy in adults with SCD. Both surveys should take ~5 minutes to complete. We estimate that these surveys will reach ~250 patients over the six months they are administered. Informed consent will obtained prior to completion of the surveys and watching the video. Survey responses will remain anonymous with no patient identifying information required for completion. Data will be stored and protected using the secure REDCap database.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, COVID-19 Vaccine, Vaccine Hesitancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
measurement by survey before and after intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
SCD-specific COVID-19 vaccination information (SCVI) video
Other Intervention Name(s)
Video
Intervention Description
SCD-specific COVID-19 vaccination information (SCVI) video developed by health care providers with input from a community advisory board of people with sickle cel disease and their caregivers.
Primary Outcome Measure Information:
Title
Vaccine hesitancy
Description
To assess vaccine hesitancy in patients not vaccinated for COVID-19, we will ask participants "how likely are you to get vaccinated for COVID-19 in the future?". Response options will be dichotomized into not hesitant ("likely or somewhat likely") vs neutral vs hesitant ("somewhat unlikely or not likely"). We will also assess vaccine hesitancy for people
Time Frame
before and after watching video
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of sickle cell disease
Exclusion Criteria:
unable to read or understand spoken English to complete the survey
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Thrower, MD
Phone
919-684-0628
Email
ashley.thrower@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Strouse, MD, PhD
Phone
919-684-0628
Email
john.strouse@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Strouse, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Adult Sickle Cell Program
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Thrower, MD
Phone
919-684-0628
Email
ashley.thrower@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease
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