Clinical trial NCT03628885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus Vaccines
Attitude to Health
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 908
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial Assignment
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Intention to Vaccinate Against HPV in the Next 12 Months
timeFrame: Immediately after video intervention has been administered
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Gregory D Zimet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.