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Clinical Trials/NCT06704308
NCT06704308
Not Yet Recruiting
N/A

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

Anne E Ray1 site in 1 country58 target enrollmentMay 1, 2026

Overview

Phase
N/A
Intervention
Web Application
Conditions
HPV Vaccination
Sponsor
Anne E Ray
Enrollment
58
Locations
1
Primary Endpoint
Change in HPV Vaccine Hesitancy Scale score
Status
Not Yet Recruiting
Last Updated
26 days ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2026
End Date
November 1, 2026
Last Updated
26 days ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Anne E Ray
Responsible Party
Sponsor Investigator
Principal Investigator

Anne E Ray

Associate Professor

University of Kentucky

Eligibility Criteria

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

  • Not provided

Arms & Interventions

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.

Intervention: Web Application

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.

Intervention: Provider Elaborated Prompts

Outcomes

Primary Outcomes

Change in HPV Vaccine Hesitancy Scale score

Time Frame: From pretest to posttest (up to two weeks)

9-item scale from Strongly Disagree (1) to Strongly Agree (5); scores range from 1-5, with higher scores indicating greater hesitancy

Change Human Papillomavirus Knowledge Questionnaire score

Time Frame: From pretest to posttest (up to two weeks)

13-item scale with True / False / I don't know response options; scores range from 0-13 with higher scores indicating greater vaccine knowledge

Change in intent to discuss HPV vaccine with provider

Time Frame: From pretest to posttest (up to two weeks)

Answers include Very likely; Somewhat likely; Not too likely; Not likely at all; Not sure / do not know

Change in HPV vaccine intent

Time Frame: From pretest to posttest (up to two weeks)

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

Change in self-reported HPV vaccination and related provider recommendations

Time Frame: from screening to posttest (up to two weeks)

4 items adapted from the NIS-TEEN survey.

Change in Reasons Not to Vaccinate score

Time Frame: Pretest only

16 items adapted from NIS-TEEN survey; higher score indicates more obstacles to vaccination

Study Sites (1)

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