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

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.

Study Overview

• Status: Completed
• Conditions: Influenza Vaccines; Human Papillomavirus Vaccines; Attitude to Health
• Intervention / Treatment: Behavioral: Provider Communication about Vaccination

• Study Type: Interventional
• Enrollment (Actual): 1165
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1. HPV + Control + Control; HPV is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination.
Experimental: Arm 2. HPV + Control + Strong; HPV is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 3. HPV + Control + Disclosure; 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.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 4. HPV + Safety + Control; 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.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 5. HPV + Safety + Strong; HPV is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 6. HPV + Safety + Disclosure; 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.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
No Intervention: Arm 7. Flu + Control + Control; Flu is target vaccine. No message regarding relative safety of vaccine; Provider provides brief routine recommendation for vaccination.
Experimental: Arm 8. Flu + Control + Strong; Flu is target vaccine; No message regarding relative safety of vaccine; Provider provides strong recommendation for vaccination.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 9. Flu + Control + Disclosure; 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.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 10. Flu + Safety + Control; 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.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 11. Flu + Safety + Strong; Flu is target vaccine; Provider provides message about relative safety of vaccination compared to other common daily activities; Provider provides strong recommendation for vaccination.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
Experimental: Arm 12. Flu + Safety + Disclosure; 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.	Behavioral: Provider Communication about Vaccination; There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Willingness to vaccinate child with target vaccine	During survey administration, at approximately 15 minutes into the survey.

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Gregory D Zimet, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimated): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 8645194