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

Study Overview
=================
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.

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

Conditions
-----------------
Human Papilloma Virus Vaccines, Attitude to Health

Intervention / Treatment
-----------------
* Behavioral: Top Concern Tailored Intervention
* Behavioral: All Concerns Tailored Intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: General Vaccine Information<br>Brief (47 second) animated informational video about vaccines recommended for all young adolescents. | |
| Experimental: Top Concern Tailored Intervention<br>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<br>* 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.<br>|
| Experimental: All Concerns Tailored Intervention<br>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<br>* 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.<br>|

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 |