Stories to Prevent (StoP) HPV Cancers: A Communication Intervention to Increase HPV Vaccination Among Diverse Populations.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HPV vaccine initiation, 9-12 year olds
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 12 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cancer survivor narrative video
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.
干预措施: Cancer survivor narrative (Other)
Placebo video
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.
干预措施: Healthy eating tips (Other)
结局指标
主要结局
HPV vaccine initiation, 9-12 year olds
时间窗: One week after clinic visit
The proportion of children ages 9-12 who have initiated HPV vaccination (first dose) during their scheduled clinic visit.
次要结局
- HPV vaccine initiation stratified by age(One week after clinic visit)
- HPV vaccine initiation stratified by sex(One week after clinic visit)
- HPV vaccine initiation stratified by race/ethnicity(One week after clinic visit)
- HPV vaccine communication in clinics(One week after clinic visit)
- Believability(One week after the intervention)
- Character identification(One week after the intervention)
- Health beliefs(One week after the intervention)
- Positive affect(One week after the intervention)
- Negative affect(One week after the intervention)
- Acceptability of digital health interventions(One week after the intervention)
研究者
William Calo
Associate Professor of Public Health Sciences
Milton S. Hershey Medical Center