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

Primary Purpose

Human Papilloma Virus Vaccines, Attitude to Health

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Top Concern Tailored Intervention
All Concerns Tailored Intervention
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus Vaccines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

General Vaccine Information

Top Concern Tailored Intervention

All Concerns Tailored Intervention

Arm Description

Brief (47 second) animated informational video about vaccines recommended for all young adolescents.

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).

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".

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2018
Last Updated
April 1, 2019
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03628885
Brief Title
An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination
Official Title
"Keeping All Teens Healthy Study": An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
September 27, 2018 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Vaccines, Attitude to Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Factorial Assignment
Masking
ParticipantInvestigator
Masking Description
Intervention videos delivered via anonymous online surveys through Survey Sampling International. Randomization to condition is built into the online survey. Participants will not know to which condition they will be randomized. Investigators are blinded by virtue of the built in randomization and anonymity of the survey.
Allocation
Randomized
Enrollment
908 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Vaccine Information
Arm Type
No Intervention
Arm Description
Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
Arm Title
Top Concern Tailored Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
All Concerns Tailored Intervention
Arm Type
Experimental
Arm Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Top Concern Tailored Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
All Concerns Tailored Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intention to Vaccinate Against HPV in the Next 12 Months
Description
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.
Time Frame
Immediately after video intervention has been administered

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mothers or female guardians of children 11-14 years of age
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Zimet, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32199723
Citation
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.
Results Reference
derived

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

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