Parents' HPV Stories

Development and Preliminary Evaluation of a Multilevel Intervention to Increase HPV Vaccine Confidence Among Parents of Youth in Rural KY

The goal of this clinical trial is to evaluate the feasibility of intervention implementation in two clinics in rural KY, and its preliminary efficacy with regards to increasing vaccine confidence in a sample of vaccine hesitant parents.

Hypothesis: Parents will report increased vaccine confidence scores post-intervention.

Data from this study will provide preliminary data for a larger scale evaluation of the intervention.

Participants will be asked to complete surveys, view a web-based intervention and then visit with their child's healthcare provider.

Study Overview

• Status: Not yet recruiting
• Conditions: HPV Vaccination
• Intervention / Treatment: Behavioral: Web Application; Behavioral: Provider Elaborated Prompts

Detailed Description

Participants will be asked to complete a brief screening assessment to establish their eligibility for participation. Eligible participants will be asked to complete a consent form and be directed to the pre-test survey. Upon completion of the survey, the participants will be directed to the tailored intervention content, including the Parents' Stories videos. This step will be completed prior to interaction with the provider. During the provider-patient visit, the provider will deliver the elaborated prompt portion of the intervention to participating mothers. Mothers will receive a link to the post-test survey two weeks following their appointment.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne E Ray, PhD; Phone Number: 859-218-4944; Email: anne.ray@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University Of Kentucky
      • Contact: Anne E Ray, PhD; Phone Number: 859-218-4944; Email: anne.ray@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• status as a mother or female guardian of an 11-17-year-old adolescent
• status as a U.S. resident
• self-reported ability to read English
• self-reported HPV vaccine hesitant using established methodology

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Parents' Stories Web Application + Provider Elaborated Prompts; Participating parents will be asked to navigate a web application that consists of (a) brief, 90-second narrative videos that encourage parent-provider communication about the vaccine and (b) personalized feedback to parents that is tailored to provide educational content in response to their concerns and be motivational in nature. Providers will provide elaborated prompts related to the vaccine when meeting with parents tailored to their concerns.

Behavioral: Web Application; A web application for vaccine-hesitant parents and their teens with brief, 90-second narrative videos and tailored, motivational content; Behavioral: Provider Elaborated Prompts; A component for providers that suggests elaborated prompts to be used with parents that align with the content of the web application, are tailored to parent concerns, and are motivational in nature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HPV Vaccine Hesitancy Scale score	9-item scale from Strongly Disagree (1) to Strongly Agree (5); scores range from 1-5, with higher scores indicating greater hesitancy	From pretest to posttest (up to two weeks)
Change Human Papillomavirus Knowledge Questionnaire score	13-item scale with True / False / I don't know response options; scores range from 0-13 with higher scores indicating greater vaccine knowledge	From pretest to posttest (up to two weeks)
Change in intent to discuss HPV vaccine with provider	Answers include Very likely; Somewhat likely; Not too likely; Not likely at all; Not sure / do not know	From pretest to posttest (up to two weeks)
Change in HPV vaccine intent	1 item adapted from NIS-TEEN survey. Answers include very likely; somewhat likely; not too likely; not likely at all; not sure / do not know	From pretest to posttest (up to two weeks)
Change in self-reported HPV vaccination and related provider recommendations	4 items adapted from the NIS-TEEN survey.	from screening to posttest (up to two weeks)
Change in Reasons Not to Vaccinate score	16 items adapted from NIS-TEEN survey; higher score indicates more obstacles to vaccination	Pretest only

Collaborators and Investigators

• Sponsor: Anne E Ray
• Collaborators: Real Prevention, LLC; Merck Institute for Therapeutic Research
• Investigators: Principal Investigator: Anne E Ray, PhD., University Of Kentucky; Study Chair: Aaron Kruse-Diehr, PhD, University Of Kentucky; Study Chair: Michael Hecht, PhD, Real Prevention, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 95632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No