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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03856437
Other study ID # 1322177-1.1
Secondary ID R01CA219060
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2021
Est. completion date April 15, 2022

Study information

Verified date March 2024
Source University of Maryland, College Park
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1170
Est. completion date April 15, 2022
Est. primary completion date March 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Behavioral:
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.

Locations

Country Name City State
United States University of Maryland College Park Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, College Park National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attitudes 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)
Primary Intention to Vaccinate Free of Cost 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 Intention to Vaccinate With Cost 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)
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