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Not yet recruiting NCT06704308

Parents' HPV Stories

No phase Interventional HPV Vaccination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Web Application, Provider Elaborated Prompts.
Who it may be relevant to
Registry conditions: HPV Vaccination. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Change in HPV Vaccine Hesitancy Scale score [Time frame: From pretest to posttest (up to two weeks)]
  • Change Human Papillomavirus Knowledge Questionnaire score [Time frame: From pretest to posttest (up to two weeks)]
  • Change in intent to discuss HPV vaccine with provider [Time frame: From pretest to posttest (up to two weeks)]
  • Change in HPV vaccine intent [Time frame: From pretest to posttest (up to two weeks)]
  • Change in self-reported HPV vaccination and related provider recommendations [Time frame: from screening to posttest (up to two weeks)]
  • Change in Reasons Not to Vaccinate score [Time frame: Pretest only]

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT06704308 · 95632

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗