Stories to Prevent (StoP) HPV Cancers

Stories to Prevent (StoP) HPV Cancers: A Communication Intervention to Increase HPV Vaccination Among Diverse Populations.

This randomized controlled trial (RCT) evaluates the association of a narrative communication intervention on human papillomavirus (HPV) vaccination rates among 9- to 12-year-olds. The intervention is a brief video from local cancer survivors narrating their stories with an HPV-related cancer diagnosis and recommending the HPV vaccine for cancer prevention. RCT participants will be the parents (n=200) of children ages 9-12 who have not initiated HPV vaccination. Participants will be randomized (1:1) to our intervention or control (placebo video) one week before their child's next primary care visit. Our primary outcome is HPV vaccine initiation (first dose of the HPV vaccine series) among children ages 9-12 at the time of the wellness visit. The study also explores the effect of narratives on theory-based mediators of HPV vaccination, including parents' cognitive (e.g., risk perception) and emotional reactions (e.g., hope, anticipated regret).

Study Overview

• Status: Recruiting
• Conditions: Emotions; Human Papillomavirus Vaccination
• Intervention / Treatment: Other: Cancer survivor narrative; Other: Healthy eating tips

Detailed Description

Despite the availability of the human papillomavirus (HPV) vaccine that can prevent over 37,300 HPV-related cancers in the US every year, only 62.6% of girls and boys were up-to-date in 2022. Low-quality provider recommendations and time constraints during clinic visits limit parents' opportunities to discuss and make HPV vaccination decisions. Pre-visit education to parents could complement provider communication to promote HPV vaccination. There is a critical need to identify better communication strategies to increase HPV vaccine uptake, including the use of narrative messaging and existing digital technologies in clinics and at home (electronic health records, patient portal, mobile devices). The Stories to Prevent (StoP) HPV Cancers Study is a randomized controlled trial (RCT) to evaluate the association of a narrative communication intervention delivered through digital and mobile technology before clinic visits on HPV vaccine initiation rates. A sample of 200 parents of unvaccinated children ages 9-12 will be randomized to receive our intervention or control (placebo video). Participants will be recruited from general pediatric and family medicine clinics affiliated with Penn State Health. We will also examine the effect of narrative communication on theory-based psychological mediators of HPV vaccine initiation and narrative communication processes, specifically parents' cognitive and emotional reactions.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William A Calo, PhD; Phone Number: 717-531-3535; Email: wcalo@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Health
      • Contact: Ben Fogel, MD; Phone Number: 717-531-7300; Email: bfogel@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parent/guardian of a 9-12 year old receiving primary care at a Penn State Health clinic
• Their child has not previously received or initiated the HPV vaccine
• Is able to read and understand spoken English or Spanish
• Has a valid email address and access to a mobile phone, table, desktop or laptop computer to engage in the intervention

Exclusion Criteria:

• Parent of guardian is less than 18 years of age
• Unable to read and understand spoken English or Spanish
• Does not have access to a mobile phone, table, desktop or laptop computer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cancer survivor narrative video; Parents randomly assigned to this arm will receive the video intervention using their personal devices around two weeks before their child's wellness visit. The video will be approximately 4 minutes in length with three parts: (1) Cancer experience, (2) Vaccine recommendation, and (3) Closing message.	Other: Cancer survivor narrative; The narrative video intervention has three parts: (1) Cancer experience - the cancer survivor narrates his/her experience with an HPV-related cancer, including diagnosis, treatment, and how cancer affected their personal life or family; (2) Vaccine recommendation - the cancer survivor provides brief information about the safety and effectiveness of the HPV vaccine and recommend that parents get the HPV vaccine for their child to prevent cancers; and (3) Closing message - The sentence "HPV vaccine is cancer prevention. Talk to your child's healthcare provider about getting the HPV vaccine during the next clinic visit" will appear on the screen.
Placebo Comparator: Placebo video; Parents randomly assigned to this arm will receive the placebo video using their personal devices around two weeks before their child's wellness visit. The placebo video is about healthy eating tips for families with children. The video will be approximately 4 minutes in length.	Other: Healthy eating tips; A publicly available video about healthy eating tips for families with children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccine initiation, 9-12 year olds	The proportion of children ages 9-12 who have initiated HPV vaccination (first dose) during their scheduled clinic visit.	One week after clinic visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccine initiation stratified by age	The proportion of children ages 9-12 who have initiated HPV vaccination (first dose) by during their scheduled clinic visit stratified by age group (9-10 vs 11-12)	One week after clinic visit
HPV vaccine initiation stratified by sex	The proportion of children ages 9-12 who have initiated HPV vaccination (first dose) during their scheduled clinic visit stratified by sex (male vs female)	One week after clinic visit
HPV vaccine initiation stratified by race/ethnicity	The proportion of children ages 9-12 who have initiated HPV vaccination (first dose) during their scheduled clinic visit stratified by race/ethnicity (White, Black, Hispanic, Others)	One week after clinic visit
HPV vaccine communication in clinics	Measure quality indicators of HPV vaccine recommendation, including the use of a presumptive announcement (i.e., noting the child's age, saying the child should get the vaccine today, using language that assumes the parent will accept the vaccine, focusing on disease prevention) and opportunities for the parent to voice concerns or questions and receive answers from the provider.	One week after clinic visit
Believability	Measure adapted from 12 items focusing on coverage, plausibility, completeness, and consistency with a 5-point scale (5=strongly agree to 1=strongly disagree)	One week after the intervention
Character identification	Measure adapted from 6 items that use a 5-point scale focusing on similarity (5=strongly agree to 1=strongly disagree)	One week after the intervention
Health beliefs	Measure adapted from 31 items focusing on risk susceptibility, severity, barriers, benefits, and self-efficacy rated on a 5-point scale (5=strongly agree to 1=strongly disagree)	One week after the intervention
Positive affect	Measure adapted from 3 items on hope using a 5-point scale (5=strongly agree to 1=strongly disagree)	One week after the intervention
Negative affect	Measure adapted from 9 items on negative affect using a 5-point scale (5=strongly agree to 1=strongly disagree)	One week after the intervention
Acceptability of digital health interventions	Measure adapted from 10 items to assess acceptability of digital health interventions using 5-point scale (5=strongly agree to 1=strongly disagree).	One week after the intervention

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Emotions; Human papillomavirus vaccine; Narrative communication
• Other Study ID Numbers: STUDY00025798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No