NCT05998824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

September 19, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

December 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

August 17, 2023

Last Update Submit

December 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Adults With Sickle Cell Disease

OTHER

Age 18 years or older

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

Interventions

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.

Also known as: Video
Adults With Sickle Cell Disease

Eligibility Criteria

Age18 Years - 100 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of sickle cell disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Adult Sickle Cell Program

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anemia, Sickle CellVaccination Hesitancy

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • John Strouse, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: measurement by survey before and after intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 21, 2023

Study Start

September 19, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

December 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations