Clinical trial NCT06808776: Stories to Prevent (StoP) HPV Cancers
Official title: Stories to Prevent (StoP) HPV Cancers: A Communication Intervention to Increase HPV Vaccination Among Diverse Populations.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Human Papillomavirus Vaccination
Emotions
Keywords: Human papillomavirus vaccine
Narrative communication
Emotions
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HPV vaccine initiation, 9-12 year olds
timeFrame: One week after clinic visit
Secondary outcomes:
measure: HPV vaccine initiation stratified by age
timeFrame: One week after clinic visit
measure: HPV vaccine initiation stratified by sex
timeFrame: One week after clinic visit
measure: HPV vaccine initiation stratified by race/ethnicity
timeFrame: One week after clinic visit
measure: HPV vaccine communication in clinics
timeFrame: One week after clinic visit
measure: Believability
timeFrame: One week after the intervention
measure: Character identification
timeFrame: One week after the intervention
measure: Health beliefs
timeFrame: One week after the intervention
measure: Positive affect
timeFrame: One week after the intervention
measure: Negative affect
timeFrame: One week after the intervention
measure: Acceptability of digital health interventions
timeFrame: One week after the intervention
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
Study officials:
References: