Parents' HPV Stories

Not Applicable

Not yet recruiting

• Conditions: HPV Vaccination

• Registration Number: NCT06704308
• Lead Sponsor: Anne E Ray

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2025-11
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in HPV Vaccine Hesitancy Scale score	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	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	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	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	from screening to posttest (up to two weeks)	4 items adapted from the NIS-TEEN survey.
Change in Reasons Not to Vaccinate score	Pretest only	16 items adapted from NIS-TEEN survey; higher score indicates more obstacles to vaccination

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States