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Human Papilloma Virus VaccinesNCT03628885

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

A study testing Top Concern Tailored Intervention and All Concerns Tailored Intervention in people with Human Papilloma Virus Vaccines and Attitude to Health, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Top Concern Tailored Intervention and All Concerns Tailored Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
908 participants
Where
1 siteUnited States
Study dates
11 Sep 2018to 27 Sep 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: "Keeping All Teens Healthy Study": 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.

Read the 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.

Being tested
Top Concern Tailored Intervention, All Concerns Tailored Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Top Concern Tailored InterventionBehavioural

    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 InterventionBehavioural

    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.

Study groups in NCT03628885
Study groupRoleWhat they receive
General Vaccine InformationNo interventionBrief (47 second) animated informational video about vaccines recommended for all young adolescents.
Top Concern Tailored InterventionExperimentalIntervention 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).
Receives: Behavioral: Top Concern Tailored Intervention
All Concerns Tailored InterventionExperimentalIntervention 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".
Receives: Behavioral: All Concerns Tailored Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately after video intervention has been administered

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start11 Sep 2018
  3. Primary completion27 Sep 2018
  4. Study completion27 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
Factorial Assignment
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
908 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03628885
Sponsor's protocol ID
1807664964
Status last verified
Jul 2018
First submitted
7 Aug 2018
Last updated
2 Apr 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36854366

  • 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.

    PubMed 32199723

Questions about this trial

What is this clinical trial studying?

A study testing Top Concern Tailored Intervention and All Concerns Tailored Intervention in people with Human Papilloma Virus Vaccines and Attitude to Health, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intention to Vaccinate Against HPV in the Next 12 Months (time frame: Immediately after video intervention has been administered). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03628885, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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