Stories to Prevent (StoP) HPV Cancers

Not Applicable

Not yet recruiting

• Conditions: Human Papillomavirus Vaccination; Emotions

• Registration Number: NCT06808776
• Lead Sponsor: Milton S. Hershey Medical Center

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).

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 Timeline

• Study First Submitted: 2025-01-29
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Study Start: 2025-08-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
HPV vaccine initiation stratified by age	One week after clinic visit	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)
HPV vaccine initiation stratified by sex	One week after clinic visit	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)
HPV vaccine initiation stratified by race/ethnicity	One week after clinic visit	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)
HPV vaccine communication in clinics	One week after clinic visit	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.
Believability	One week after the intervention	Measure adapted from 12 items focusing on coverage, plausibility, completeness, and consistency with a 5-point scale (5=strongly agree to 1=strongly disagree)
Character identification	One week after the intervention	Measure adapted from 6 items that use a 5-point scale focusing on similarity (5=strongly agree to 1=strongly disagree)
Health beliefs	One week after the intervention	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)
Positive affect	One week after the intervention	Measure adapted from 3 items on hope using a 5-point scale (5=strongly agree to 1=strongly disagree)
Negative affect	One week after the intervention	Measure adapted from 9 items on negative affect using a 5-point scale (5=strongly agree to 1=strongly disagree)
Acceptability of digital health interventions	One week after the intervention	Measure adapted from 10 items to assess acceptability of digital health interventions using 5-point scale (5=strongly agree to 1=strongly disagree).

Trial Locations

Locations (1)

Penn State Health; 🇺🇸 Hershey, Pennsylvania, United States