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

NCT03628885 | Completed Results

• 1 other identifier: 1807664964
• Study Type: interventional
• Target: 908
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papilloma Virus Vaccines; Attitude to Health

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

General Vaccine Information

NO INTERVENTION

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

Top Concern Tailored Intervention

EXPERIMENTAL

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

All Concerns Tailored Intervention

EXPERIMENTAL

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

Interventions

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.

Top Concern Tailored Intervention

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.

All Concerns Tailored Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mothers or female guardians of children 11-14 years of age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Srivastava T, Head KJ, O'Dell SM, Feemster KA, Panozzo CA, Zimet GD, Kornides ML. Characterizing U.S. mothers with high human papillomavirus vaccine intent yet unvaccinated adolescents. Prev Med. 2023 Apr;169:107472. doi: 10.1016/j.ypmed.2023.107472. Epub 2023 Feb 26.

  PMID: 36854366 DERIVED

• 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.

  PMID: 32199723 DERIVED

Limitations and Caveats

A limitation of this trial is that the outcome is intention to vaccinate, rather than actual vaccination.

Results Point of Contact

• Title: Dr. Gregory Zimet
• Organization: Indiana University

gzimet@iu.edu

3172748812

Study Officials

• Gregory D Zimet, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Factorial Assignment

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: September 11, 2018
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)