Video-assisted Counseling for Human Papillomavirus Vaccination: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- HPV vaccine initiation
研究概览
简要总结
Video-assisted counseling has been shown to improve consistency of counseling regarding a wide variety of health-care related issues. West Cancer Center has shown a significant increase in breast cancer susceptibility gene testing in ovarian cancer patients following video-assisted counseling compared to traditional provider-led counseling. This trial is designed to determine if video-assisted counseling can improve HPV vaccination rates by providing consistent counseling in a timely fashion.
详细描述
- Purpose
To increase human papillomavirus (HPV) vaccination series initiation and completion in an outpatient pediatric clinic as well as to assess attitudinal and logistic barriers to HPV vaccination. 2. Rationale
HPV is the most common sexually transmitted infection and is implicated in the development of oropharyngeal and anogenital cancers. Currently three vaccinations against HPV are available: a bivalent vaccine (HPV types 16 and 18), quadrivalent vaccine (HPV types 6, 11, 16, 18), and 9-valent vaccine (HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58). The 9-valent vaccine vaccinates against HPV types that cause approximately 90% of cervical cancers, anal cancers, anogenital warts and a significant proportion of oropharyngeal, vulvar, vaginal and penile cancers.
Although HPV vaccination has been proven to significantly decrease the incidence of anogenital dysplasia, widespread acceptance among patients and providers has been difficult to achieve. The 2015 National Immunization Survey-Teen data found for females and males ages 13-17, 63 and 50 percent received ≥1 dose and 42 and 28 percent received all three doses respectively. Multiple studies have identified barriers to HPV vaccination including attitudes toward HPV, lack of provider recommendation or appropriate counseling, lack of provider knowledge, paucity of preventative care visits and inadequate time for appropriate counseling. HPV vaccination is especially difficult in an urban practice setting given racial and socioeconomic discrepancies in patient understanding of HPV vaccination and unique barriers to vaccination series completion. Regardless of race or socioeconomic background, however, >95% of parents trust their doctor's advice on HPV vaccination, highlighting the need for consistent and clear counseling among all providers caring for patients ages 9-26.
The West Cancer Center in Memphis, TN recently published data on video-assisted genetic counseling in patients with ovarian, fallopian tube and primary peritoneal cancer. In eligible patients, a 7 minute counseling video increased the rate of breast cancer susceptibility gene testing by 25% compared to traditional, provider-led counseling. Given these results we sought to apply the concept of video-assisted counseling to HPV vaccination in the pediatric population. 3. Study/Project Population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ages 9-18 years who have not completed the HPV vaccination series
- •Parents or legal guardians of children ages 9-18 who have not completed the HPV vaccination series who are enrolled in the study
排除标准
- •Hypersensitivity to yeast
- •Hypersensitivity to prior HPV vaccination
结局指标
主要结局
HPV vaccine initiation
时间窗: 1 month
Percentage of adolescents enrolled initiating HPV vaccination
次要结局
- Visit time(1 day)
- HPV vaccine completion(9 months)
- Improvement HPV knowledge(1 day)
- Barriers to HPV vaccination(1 day)
研究者
Michael Ulm
Principal Investigator
Le Bonheur Children's Hospital