Penn State Health
Hershey, Pennsylvania, 17033, United States
Location status: Recruiting
NCT Number: NCT06808776
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
A publicly available video about healthy eating tips for families with children.
Time frame: One week after clinic visit
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 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: One week after the intervention
Measure adapted from 3 items on hope using a 5-point scale (5=strongly agree to 1=strongly disagree)
Time frame: 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)
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Milton S. Hershey Medical Center
Other
Stories to Prevent (StoP) HPV Cancers: A Communication Intervention to Increase HPV Vaccination Among Diverse Populations.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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