Stories to Prevent (StoP) HPV Cancers

NCT06808776 | Recruiting

• 1 other identifier: STUDY00025798
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Human Papillomavirus Vaccination; Emotions

Keywords

Human papillomavirus vaccine; Narrative communication; Emotions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• HPV vaccine initiation stratified by age

  One week after clinic visit

• HPV vaccine initiation stratified by sex

  One week after clinic visit

• HPV vaccine initiation stratified by race/ethnicity

  One week after clinic visit

• HPV vaccine communication in clinics

  One week after clinic visit

• Believability

  One week after the intervention

Study Arms (2)

Cancer survivor narrative video

EXPERIMENTAL

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

Placebo video

PLACEBO COMPARATOR

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

Interventions

Healthy eating tips OTHER

A publicly available video about healthy eating tips for families with children.

Placebo video

Cancer survivor narrative OTHER

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.

Cancer survivor narrative video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health

Hershey, Pennsylvania, 17033, United States

RECRUITING

Central Study Contacts

William A Calo, PhD

CONTACT

717-531-3535; wcalo@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health Sciences

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)