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Completed

NCT Number: NCT03628885

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Top Concern Tailored Intervention

Behavioral

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.

All Concerns Tailored Intervention

Behavioral

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 outcomes

  1. Intention to Vaccinate Against HPV in the Next 12 Months

    Time frame: Immediately after video intervention has been administered

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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