NCT02358083

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

February 3, 2015

Last Update Submit

October 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Willingness to vaccinate child with target vaccine

    During survey administration, at approximately 15 minutes into the survey.

Study Arms (12)

Arm 1. HPV + Control + Control

NO INTERVENTION

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

Arm 2. HPV + Control + Strong

EXPERIMENTAL

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

Behavioral: Provider Communication about Vaccination

Arm 3. HPV + Control + Disclosure

EXPERIMENTAL

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

Arm 4. HPV + Safety + Control

EXPERIMENTAL

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

Arm 5. HPV + Safety + Strong

EXPERIMENTAL

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

Arm 6. HPV + Safety + Disclosure

EXPERIMENTAL

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

Arm 7. Flu + Control + Control

NO INTERVENTION

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

Arm 8. Flu + Control + Strong

EXPERIMENTAL

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

Behavioral: Provider Communication about Vaccination

Arm 9. Flu + Control + Disclosure

EXPERIMENTAL

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

Arm 10. Flu + Safety + Control

EXPERIMENTAL

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

Arm 11. Flu + Safety + Strong

EXPERIMENTAL

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

Arm 12. Flu + Safety + Disclosure

EXPERIMENTAL

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

Interventions

There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.

Arm 10. Flu + Safety + ControlArm 11. Flu + Safety + StrongArm 12. Flu + Safety + DisclosureArm 2. HPV + Control + StrongArm 3. HPV + Control + DisclosureArm 4. HPV + Safety + ControlArm 5. HPV + Safety + StrongArm 6. HPV + Safety + DisclosureArm 8. Flu + Control + StrongArm 9. Flu + Control + Disclosure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Gregory D Zimet, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 31, 2023

Record last verified: 2023-10