Parents' HPV Stories

NCT06704308 | Not Yet Recruiting

• 1 other identifier: 95632
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Vaccination

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Parents' Stories Web Application + Provider Elaborated Prompts

EXPERIMENTAL

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; Behavioral: Provider Elaborated Prompts

Interventions

Provider Elaborated Prompts BEHAVIORAL

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

Parents' Stories Web Application + Provider Elaborated Prompts

Web Application BEHAVIORAL

A web application for vaccine-hesitant parents and their teens with brief, 90-second narrative videos and tailored, motivational content

Parents' Stories Web Application + Provider Elaborated Prompts

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Merck Institute for Therapeutic Research: collaborator
• Anne E Ray: lead
• Real Prevention, LLC: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Study Officials

• Anne E Ray, PhD.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Aaron Kruse-Diehr, PhD

  University of Kentucky

  STUDY CHAIR

• Michael Hecht, PhD

  Real Prevention, LLC

  STUDY CHAIR

Central Study Contacts

Anne E Ray, PhD

CONTACT

859-218-4944; anne.ray@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)