COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998824
• Other study ID #: Pro00110966
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Ashley Thrower, MD
• Phone: 919-684-0628
• Email: ashley.thrower[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• diagnosis of sickle cell disease

Exclusion Criteria:

• unable to read or understand spoken English to complete the survey

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• COVID-19
• COVID-19 Vaccine
• Sickle Cell Disease
• Vaccine Hesitancy

Intervention

Behavioral:
• SCD-specific COVID-19 vaccination information (SCVI) video
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.

Locations

Country	Name	City	State
United States	Duke Adult Sickle Cell Program	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	American Society of Hematology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	before and after watching video