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Stories to Prevent (StoP) HPV Cancers

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06808776
Enrollment
200
Registered
2025-02-05
Start date
2025-11-18
Completion date
2027-03-31
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotions, Human Papillomavirus Vaccination

Keywords

Human papillomavirus vaccine, Narrative communication, Emotions

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.

Interventions

OTHERCancer 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.

OTHERHealthy eating tips

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

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HPV vaccine initiation, 9-12 year oldsOne week after clinic visitThe proportion of children ages 9-12 who have initiated HPV vaccination (first dose) during their scheduled clinic visit.

Secondary

MeasureTime frameDescription
HPV vaccine initiation stratified by ageOne week after clinic visitThe 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 sexOne week after clinic visitThe 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 communication in clinicsOne week after clinic visitMeasure 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.
BelievabilityOne week after the interventionMeasure adapted from 12 items focusing on coverage, plausibility, completeness, and consistency with a 5-point scale (5=strongly agree to 1=strongly disagree)
Character identificationOne week after the interventionMeasure adapted from 6 items that use a 5-point scale focusing on similarity (5=strongly agree to 1=strongly disagree)
Health beliefsOne week after the interventionMeasure 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 affectOne week after the interventionMeasure adapted from 3 items on hope using a 5-point scale (5=strongly agree to 1=strongly disagree)
Negative affectOne week after the interventionMeasure adapted from 9 items on negative affect using a 5-point scale (5=strongly agree to 1=strongly disagree)
HPV vaccine initiation stratified by race/ethnicityOne week after clinic visitThe 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)
Acceptability of digital health interventionsOne week after the interventionMeasure adapted from 10 items to assess acceptability of digital health interventions using 5-point scale (5=strongly agree to 1=strongly disagree).

Countries

United States

Contacts

CONTACTWilliam A Calo, PhD
wcalo@pennstatehealth.psu.edu717-531-3535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026