search
Back to results

Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents

Primary Purpose

Human Papillomavirus Vaccines, Influenza Vaccines, Attitude to Health

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Provider Communication about Vaccination
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papillomavirus Vaccines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Lives in United States
  • Mother or female legal guardian of at least one child aged 9-13
  • Able to understand English
  • For HPV condition: Target child must not have received any doses of HPV vaccine
  • For Flu condition: Target child must not have received the flu vaccine during the prior flu season

Exclusion Criteria:

  • Under 18 years of age
  • Not mother or female legal guardian of at least one child ages 9-13
  • Not living in United States
  • Not able to understand English and Spanish
  • For HPV condition: Target child had already received at least 1 dose of the HPV vaccine
  • For Flu condition: Target child received the influenza vaccine during the previous flu season

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    No Intervention

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Arm 1. HPV + Control + Control

    Arm 2. HPV + Control + Strong

    Arm 3. HPV + Control + Disclosure

    Arm 4. HPV + Safety + Control

    Arm 5. HPV + Safety + Strong

    Arm 6. HPV + Safety + Disclosure

    Arm 7. Flu + Control + Control

    Arm 8. Flu + Control + Strong

    Arm 9. Flu + Control + Disclosure

    Arm 10. Flu + Safety + Control

    Arm 11. Flu + Safety + Strong

    Arm 12. Flu + Safety + Disclosure

    Arm Description

    HPV is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination.

    HPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination.

    HPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.

    HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination.

    HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination.

    HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.

    Flu is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination.

    Flu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination.

    Flu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.

    Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination.

    Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination.

    Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.

    Outcomes

    Primary Outcome Measures

    Willingness to vaccinate child with target vaccine

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2015
    Last Updated
    February 5, 2015
    Sponsor
    Indiana University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02358083
    Brief Title
    Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents
    Official Title
    Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indiana University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (HPV) or Influenza.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Papillomavirus Vaccines, Influenza Vaccines, Attitude to Health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1165 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1. HPV + Control + Control
    Arm Type
    No Intervention
    Arm Description
    HPV is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination.
    Arm Title
    Arm 2. HPV + Control + Strong
    Arm Type
    Experimental
    Arm Description
    HPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination.
    Arm Title
    Arm 3. HPV + Control + Disclosure
    Arm Type
    Experimental
    Arm Description
    HPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.
    Arm Title
    Arm 4. HPV + Safety + Control
    Arm Type
    Experimental
    Arm Description
    HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination.
    Arm Title
    Arm 5. HPV + Safety + Strong
    Arm Type
    Experimental
    Arm Description
    HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination.
    Arm Title
    Arm 6. HPV + Safety + Disclosure
    Arm Type
    Experimental
    Arm Description
    HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.
    Arm Title
    Arm 7. Flu + Control + Control
    Arm Type
    No Intervention
    Arm Description
    Flu is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination.
    Arm Title
    Arm 8. Flu + Control + Strong
    Arm Type
    Experimental
    Arm Description
    Flu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination.
    Arm Title
    Arm 9. Flu + Control + Disclosure
    Arm Type
    Experimental
    Arm Description
    Flu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.
    Arm Title
    Arm 10. Flu + Safety + Control
    Arm Type
    Experimental
    Arm Description
    Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides brief routine recommendation for vaccination.
    Arm Title
    Arm 11. Flu + Safety + Strong
    Arm Type
    Experimental
    Arm Description
    Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination.
    Arm Title
    Arm 12. Flu + Safety + Disclosure
    Arm Type
    Experimental
    Arm Description
    Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination and personal disclosure regarding own child's vaccination history.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Provider Communication about Vaccination
    Intervention Description
    There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
    Primary Outcome Measure Information:
    Title
    Willingness to vaccinate child with target vaccine
    Time Frame
    During survey administration, at approximately 15 minutes into the survey.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Lives in United States Mother or female legal guardian of at least one child aged 9-13 Able to understand English For HPV condition: Target child must not have received any doses of HPV vaccine For Flu condition: Target child must not have received the flu vaccine during the prior flu season Exclusion Criteria: Under 18 years of age Not mother or female legal guardian of at least one child ages 9-13 Not living in United States Not able to understand English and Spanish For HPV condition: Target child had already received at least 1 dose of the HPV vaccine For Flu condition: Target child received the influenza vaccine during the previous flu season
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory D Zimet, PhD
    Organizational Affiliation
    Indiana University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents

    We'll reach out to this number within 24 hrs