COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05998824
Collaborator
American Society of Hematology (Other)
250
1
7.2
34.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SCD-specific COVID-19 vaccination information (SCVI) video
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
measurement by survey before and after interventionmeasurement by survey before and after intervention
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease
Anticipated Study Start Date :
Aug 23, 2023
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Vaccine hesitancy [before and after watching video]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • diagnosis of sickle cell disease
Exclusion Criteria:
  • unable to read or understand spoken English to complete the survey

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Adult Sickle Cell Program Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • American Society of Hematology

Investigators

  • Principal Investigator: John Strouse, MD, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John J. Strouse, M.D., Ph.D., Associate Professor, Duke University
ClinicalTrials.gov Identifier:
NCT05998824
Other Study ID Numbers:
  • Pro00110966
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023