Stories to Prevent (StoP) HPV Cancers

Penn State Health

Status: Enrolling

Conditions: Human Papillomavirus Vaccination; Emotions

Treatments: Other: Healthy eating tips; Other: Cancer survivor narrative

Study type: Interventional

Funder types: Other

Identifiers

NCT06808776

STUDY00025798

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 9 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Cancer survivor narrative video

Experimental group

Description:

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.

Treatment:

Other: Cancer survivor narrative

Placebo video

Placebo Comparator group

Description:

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.

Treatment:

Other: Healthy eating tips