Parents' HPV Stories

NCT ID: NCT06704308

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HPV Vaccination

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Web Application

Intervention Type BEHAVIORAL

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

Provider Elaborated Prompts

Intervention Type 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

Interventions

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Web Application

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anne E Ray

OTHER

Sponsor Role lead

Real Prevention, LLC

INDUSTRY

Sponsor Role collaborator

Merck Institute for Therapeutic Research

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Anne E Ray

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anne E Ray, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Aaron Kruse-Diehr, PhD

Role: STUDY_CHAIR

University of Kentucky

Michael Hecht, PhD

Role: STUDY_CHAIR

Real Prevention, LLC

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Central Contacts

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Anne E Ray, PhD

Role: CONTACT

859-218-4944

Facility Contacts

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Anne E Ray, PhD

Role: primary

859-218-4944

Other Identifiers

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95632

Identifier Type: -

Identifier Source: org_study_id

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