Stories to Prevent (StoP) HPV Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Cancer survivor narrative
Other interventionThe 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.
Healthy eating tips
Other interventionA publicly available video about healthy eating tips for families with children.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Cancer survivor narrative videoExperimental treatment 1 intervention
Group B: Placebo videoPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
One week after clinic visitSecondary outcomes
1
HPV vaccine initiation stratified by age
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)
Time frame
One week after clinic visit2
HPV vaccine initiation stratified by sex
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)
Time frame
One week after clinic visit3
HPV vaccine initiation stratified by race/ethnicity
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)
Time frame
One week after clinic visit4
HPV vaccine communication in clinics
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.
Time frame
One week after clinic visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov