A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination

March 12, 2024 updated by: University of Maryland, College Park
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants are randomized into gain and loss conditions in which they view either gain-framed or loss-framed HPV vaccination messages. Key outcome variables include parents' attitudes and intentions toward vaccinating their children against HPV.

Study Overview

Status

Completed

Detailed Description

The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants recruited from local communities and online panels will complete a computer-assisted survey. In the survey participants will first answer questions related to their beliefs about HPV and the HPV vaccine (e.g., perceived susceptibility, perceived severity, perceived efficacy, perceived safety, etc.), as well as other background information. Then they will be presented with either a gain-framed or loss-framed human papillomavirus vaccination message. After the message exposure, they will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures. Eligible participants are at least 21 years old, self-identify as African American, and are custodial parents or caretakers of at least one child ages 9-17 who has not initiated the HPV vaccine series.

Study Type

Interventional

Enrollment (Actual)

1170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older
  • Self-identify as African American
  • Custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
  • Has access to Internet to complete the study

Exclusion Criteria:

  • Younger than 18 years
  • Does not self-identify as African American
  • Not a custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
  • Has no access to Internet to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gain-framed messages
Participants in this arm receive gain-framed HPV vaccination messages.
Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV, the costs of not being vaccinated against HPV, or neither benefits or costs but simply a call for action.
Experimental: Loss-framed messages
Participants in this arm receive loss-framed HPV vaccination messages.
Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV, the costs of not being vaccinated against HPV, or neither benefits or costs but simply a call for action.
Active Comparator: Control messages
Participants in this arm receive non-framed HPV vaccination messages.
Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV, the costs of not being vaccinated against HPV, or neither benefits or costs but simply a call for action.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitudes
Time Frame: baseline posttest (test was approximately 5 minutes to complete)
Attitudes toward HPV vaccination for children Scale range: 1-7 (higher score indicates more positive attitude) Subscales were averaged.
baseline posttest (test was approximately 5 minutes to complete)
Intention to Vaccinate Free of Cost
Time Frame: baseline posttest (test was approximately 5 minutes to complete)
Intention to have children vaccinated against HPV free of cost Scale range: 1-6 (higher score indicates stronger intention) Subscales were averaged.
baseline posttest (test was approximately 5 minutes to complete)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intention to Vaccinate With Cost
Time Frame: baseline posttest (test was approximately 5 minutes to complete)
Intention to have children vaccinated against HPV free with cost Scale range: 1-6 (higher score indicates stronger intention) Subscales were averaged.
baseline posttest (test was approximately 5 minutes to complete)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiaoli Nan, University of Maryland, College Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2021

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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