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NCT Number: NCT06704308

Parents' HPV Stories

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.

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Key information

Conditions

HPV VACCINATION

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Web Application

Behavioral

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

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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 contacts

Contact information is provided by the study sponsor or research team.

Anne E Ray, PhD

CONTACT

[email protected]

859-218-4944

Sponsors and collaborators

Lead sponsor

Anne E Ray

Other

Collaborators

  • Merck Institute for Therapeutic Research
  • Real Prevention, LLC

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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