- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856437
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
Conditions
Intervention / Treatment
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.
Collaborators
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genital Neoplasms, Male
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Anus Diseases
- Penile Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Anus Neoplasms
- Penile Neoplasms
Other Study ID Numbers
- 1322177-1.1
- R01CA219060 (U.S. NIH Grant/Contract)
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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