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

Primary Purpose

Cervical Cancer, Anal Cancer, Penile Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPV vaccination messages
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Gain-framed messages

Loss-framed messages

Control messages

Arm Description

Participants in this arm receive gain-framed HPV vaccination messages.

Participants in this arm receive loss-framed HPV vaccination messages.

Participants in this arm receive non-framed HPV vaccination messages.

Outcomes

Primary Outcome Measures

Attitudes
Attitudes toward HPV vaccination will be assessed by three semantic differential items adapted from previous research. Participants will be presented with a statement (i.e., vaccinating my child against HPV would be ____) followed by adjectives such as "Bad/Good," "Stupid/Wise," and "A bad idea/A good idea."
Attitudes
Attitudes toward HPV vaccination will be assessed by three semantic differential items adapted from previous research. Participants will be presented with a statement (i.e., vaccinating my child against HPV would be ____) followed by adjectives such as "Bad/Good," "Stupid/Wise," and "A bad idea/A good idea."
Intentions
Behavioral intentions toward HPV vaccination will be assessed with three questions adapted from previous research. Participants will be asked questions such as "how likely would you be to get your child vaccinated with the HPV vaccine sometime soon?" Since cost of the vaccine is a potential barrier, all participants will be asked to indicate their intentions to get their children vaccinated for two scenarios: 1) if they have to purchase the vaccine for the full retail price at the time and 2) if the vaccine is offered to them free of cost. The two measures will be kept separate as outcome variables.
Intentions
Behavioral intentions toward HPV vaccination will be assessed with three questions adapted from previous research. Participants will be asked questions such as "how likely would you be to get your child vaccinated with the HPV vaccine sometime soon?" Since cost of the vaccine is a potential barrier, all participants will be asked to indicate their intentions to get their children vaccinated for two scenarios: 1) if they have to purchase the vaccine for the full retail price at the time and 2) if the vaccine is offered to them free of cost. The two measures will be kept separate as outcome variables.

Secondary Outcome Measures

Thoughts
Participants will be asked to list the thoughts they had while viewing the message. They will categorize the thoughts into positive (in support of the message), negative (in opposition to the message), and irrelevant.
Emotions
Participants will report how they felt while viewing the message. Anger, Guilt, Fear, Sadness, and Happiness will be measured by an established scale.
Perceived argument strength
Perceived argument strength will be measured by an established scale.

Full Information

First Posted
December 17, 2018
Last Updated
November 14, 2022
Sponsor
University of Maryland, College Park
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1. Study Identification

Unique Protocol Identification Number
NCT03856437
Brief Title
A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
Official Title
A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Anal Cancer, Penile Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gain-framed messages
Arm Type
Experimental
Arm Description
Participants in this arm receive gain-framed HPV vaccination messages.
Arm Title
Loss-framed messages
Arm Type
Experimental
Arm Description
Participants in this arm receive loss-framed HPV vaccination messages.
Arm Title
Control messages
Arm Type
Active Comparator
Arm Description
Participants in this arm receive non-framed HPV vaccination messages.
Intervention Type
Behavioral
Intervention Name(s)
HPV vaccination messages
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attitudes
Description
Attitudes toward HPV vaccination will be assessed by three semantic differential items adapted from previous research. Participants will be presented with a statement (i.e., vaccinating my child against HPV would be ____) followed by adjectives such as "Bad/Good," "Stupid/Wise," and "A bad idea/A good idea."
Time Frame
baseline posttest
Title
Attitudes
Description
Attitudes toward HPV vaccination will be assessed by three semantic differential items adapted from previous research. Participants will be presented with a statement (i.e., vaccinating my child against HPV would be ____) followed by adjectives such as "Bad/Good," "Stupid/Wise," and "A bad idea/A good idea."
Time Frame
1-month follow up
Title
Intentions
Description
Behavioral intentions toward HPV vaccination will be assessed with three questions adapted from previous research. Participants will be asked questions such as "how likely would you be to get your child vaccinated with the HPV vaccine sometime soon?" Since cost of the vaccine is a potential barrier, all participants will be asked to indicate their intentions to get their children vaccinated for two scenarios: 1) if they have to purchase the vaccine for the full retail price at the time and 2) if the vaccine is offered to them free of cost. The two measures will be kept separate as outcome variables.
Time Frame
baseline posttest
Title
Intentions
Description
Behavioral intentions toward HPV vaccination will be assessed with three questions adapted from previous research. Participants will be asked questions such as "how likely would you be to get your child vaccinated with the HPV vaccine sometime soon?" Since cost of the vaccine is a potential barrier, all participants will be asked to indicate their intentions to get their children vaccinated for two scenarios: 1) if they have to purchase the vaccine for the full retail price at the time and 2) if the vaccine is offered to them free of cost. The two measures will be kept separate as outcome variables.
Time Frame
1-month follow up
Secondary Outcome Measure Information:
Title
Thoughts
Description
Participants will be asked to list the thoughts they had while viewing the message. They will categorize the thoughts into positive (in support of the message), negative (in opposition to the message), and irrelevant.
Time Frame
baseline posttest
Title
Emotions
Description
Participants will report how they felt while viewing the message. Anger, Guilt, Fear, Sadness, and Happiness will be measured by an established scale.
Time Frame
baseline posttest
Title
Perceived argument strength
Description
Perceived argument strength will be measured by an established scale.
Time Frame
baseline posttest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoli Nan
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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