An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination

"Keeping All Teens Healthy Study": An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination

The purpose of this study is to investigate mother's attitudes about vaccinating their 11-14 year old children against the human papillomavirus (HPV). Among mothers who do not plan to vaccinate their child, the investigators will assess the influence of brief videos tailored to mothers' questions and concerns. Mothers will be randomized to one of three arms: 1. General video message about vaccination; 2. General message plus a brief video addressing the mother's primary concern; or 3. General message plus videos address all of mother-indicated concerns. The outcome of interest is intention to vaccinate. Our hypothesis is that the tailored videos will lead to increased intention to vaccinate.

Study Overview

• Status: Completed
• Conditions: Attitude to Health; Human Papilloma Virus Vaccines
• Intervention / Treatment: Behavioral: Top Concern Tailored Intervention; Behavioral: All Concerns Tailored Intervention

Detailed Description

Attitudes will be assessed through a Web-based survey administered by Survey Sampling International (SSI). The projected sample size is approximately 3,500, comprising mothers or female guardians of at least one child aged 11-14 who live in the United States. The survey will take no more than 20 minutes to complete. Mothers who indicate that they do not plan to vaccinate their children in the next year will be randomized to view brief videos tailored to their questions or concerns about HPV vaccination. The outcome of interest is intention to vaccinate. Mothers who have vaccinated their child or intend to vaccinate their child will be asked a separate set of questions relevant to this information.

Mothers who indicate that they do not intend to vaccinate their child against HPV will be asked about their questions or concerns regarding HPV vaccination (from a pre-populated list of common concerns). Mothers will be randomized to one of three arms: 1. A general information video; 2. The general video plus a video addressing their top concern; or 3. The general video plus one or more videos addressing all of their concerns. Each video is less than 50 seconds in length.

• Study Type: Interventional
• Enrollment (Actual): 908
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18 years of age or older
• Lives in one of 26 US states with lower rates of HPV vaccination (New Jersey, Virginia, West Virginia, Alabama, Florida, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Indiana, Minnesota, Ohio, Arkansas, Louisiana, New Mexico, Oklahoma, Kansas, Missouri, Montana, South Dakota, Utah, Wyoming, Idaho, Texas, Iowa)
• Mother or female legal guardian of at least one child aged 11-14 years
• Able to read and understand English
• Target child must not have received any doses of HPV vaccine
• The mother/respondent must indicate that she is not sure that she will vaccinate the target child in the next year.

Exclusion Criteria:

• Under 18 years of age
• Not a mother or female legal guardian of at least one child ages 11-14 years
• Not living in the United States or in one of the above designated states within the U.S.
• Not able to understand or read English
• Target child has already received at least 1 dose of HPV vaccine
• The mother/respondent indicates (before the intervention) that she definitely intends to vaccinate the target child with HPV vaccine in the next year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: General Vaccine Information; Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
Experimental: Top Concern Tailored Intervention; Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).	Behavioral: Top Concern Tailored Intervention; General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.
Experimental: All Concerns Tailored Intervention; Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".	Behavioral: All Concerns Tailored Intervention; General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to Vaccinate Against HPV in the Next 12 Months	Each parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children.	Immediately after video intervention has been administered

Collaborators and Investigators

• Sponsor: Indiana University

Publications and helpful links

General Publications

• Panozzo CA, Head KJ, Kornides ML, Feemster KA, Zimet GD. Tailored Messages Addressing Human Papillomavirus Vaccination Concerns Improves Behavioral Intent Among Mothers: A Randomized Controlled Trial. J Adolesc Health. 2020 Aug;67(2):253-261. doi: 10.1016/j.jadohealth.2020.01.024. Epub 2020 Mar 18.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Actual): September 27, 2018
• Study Completion (Actual): September 27, 2018

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: 1807664964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No