NCT05422898

Brief Summary

As the COVID-19 pandemic persists, a sizable proportion of the U.S. population remains unvaccinated and at high risk of death and serious illness from COVID-19. Vaccine hesitancy, fueled by the proliferation of vaccine misinformation on social media, is one factor contributing to lack of vaccination. Current attempts to overcome vaccine misinformation focus on correcting or debunking falsehoods. Although debunking strategies are important components to any public health campaign, communications must also address rationales for vaccine hesitancy that vary among individuals and communities, and directly address the gist of their concerns in an empathetic, non-judgmental manner. We will conduct a randomized controlled trial to test the effectiveness of empathic, relationship-building interactions relative to standard provision of information on social media to address COVID-19 vaccine hesitancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable covid19

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 15, 2022

Last Update Submit

June 15, 2022

Conditions

Keywords

vaccine hesitancysocial mediahealth behavior

Outcome Measures

Primary Outcomes (1)

  • Engagement and satisfaction with the program

    Engagement includes participation in the Facebook group; satisfaction=self-rated overall satisfaction with the program (7-point scale)

    4 weeks

Secondary Outcomes (6)

  • Proportion of participants getting the COVID-19 vaccine

    4 weeks

  • Change in COVID-19 vaccination intention

    4 weeks

  • Change in intention to encourage others to get the COVID-19 vaccine

    4 weeks

  • Change in COVID-19 vaccine confidence

    4 weeks

  • Change in general vaccine confidence

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Gist

EXPERIMENTAL

Gist-based messages on COVID-19 vaccination and moderated group discussions in a private Facebook group

Behavioral: Gist messages on COVID-19 vaccination

Information

PLACEBO COMPARATOR

Link to Facebook COVID-19 Information Center

Behavioral: COVID-19 vaccine information

Interventions

Participants will receive gist-based messages on COVID-19 vaccines and have their concerns addressed by a group moderator

Gist

Participants will receive a link to the Facebook COVID-19 Information Center via a private Facebook Group

Information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • reside in the U.S.
  • unvaccinated from COVID-19
  • Use Facebook regularly (at least 1/day)

You may not qualify if:

  • age \<18 years
  • do not reside in the U.S.
  • vaccinated from COVID-19
  • do not use Facebook regularly (at least 1/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

MeSH Terms

Conditions

COVID-19Vaccination HesitancyHealth Behavior

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

January 17, 2022

Primary Completion

April 4, 2022

Study Completion

April 4, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations