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临床试验/NCT03000998
NCT03000998已完成不适用

Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake

Klein Buendel, Inc.6 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2017年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
432
试验地点
6
主要终点
Vaccine Adherence

研究概览

简要总结

The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended levels, particularly for adolescent boys and especially among minority families. Proposed here is a mobile web application ("mobile web app") for personal computers, smart phones, and tablet computers that will accurately inform parents and adolescent boys about the HPV vaccination and address unique concerns about its safety and effectiveness for boys. The BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a randomized efficacy trial with parents and adolescent boys aged 11-13 years.

详细描述

The President's Cancer Advisory Board and the Centers for Disease Control have called for renewed efforts in promoting vaccination for Human Papillomavirus (HPV), including vaccination for adolescent boys, because the uptake of this new vaccine remains alarmingly low. Currently, less than 15% of adolescent boys have received the HPV vaccine; thus, most of this population remains at risk for oropharyngeal, anal, and penile cancers. Many parents remain unconvinced of the safety and effectiveness of HPV vaccines, so effective and accessible messaging to improve decision-making on this vaccine is needed. Parents of adolescent boys also have different concerns about HPV vaccination than for adolescent girls, creating a need for unique health communication interventions to promote vaccine uptake among boys. Interventions also need to address the unique challenges of minority populations and populations for whom English is not the first language. A novel digital intervention will be produced and evaluated for its ability to improve HPV vaccine outcomes. Specifically, a mobile responsive web application ("mobile web app") will be created that performs similar to a mobile app but runs on a variety of computing platforms from personal desktop and laptop computers to the latest smart phones and tablet computers. Mobile web app content will be targeted to parents and adolescent boys aged 11-13 years. The specific aims are to: 1) carefully and systematically develop a mobile web app (BoyVac) for smart phones, tablet computers, and personal computers that will utilize Diffusion of Innovations principles to provide targeted information concerning HPV vaccine adoption to adolescent males and their parents, particularly minority adolescents and parents; 2) implement a comprehensive and rigorous test of the impact of the BoyVac mobile web app intervention on HPV vaccine adoption outcomes via a randomized efficacy trial (BoyVac v. usual and customary care); and 3) examine the dose-response relationships between mobile web app usage and vaccine outcomes within a components analysis. A group-randomized pretest-posttest controlled design will be implemented, recruiting 1800 pairs of parents and adolescent boys from 30 pediatric clinics (n=60 parents and boys per clinic). Parents will be surveyed at baseline, a 3-month follow-up, and a 9-month follow-up and records HPV vaccination adoption for the boys will be obtained from the clinics' medical records at the 9-month follow-up. Analyses will test the hypotheses that 1) more 11-13 year old boys in the intervention group (BoyVac mobile web app) will adopt the HPV vaccine than boys in the usual and customary care comparison group and 2) adoption of HPV vaccine will be mediated by improvements in theoretical mediators among parents in the intervention compared to the usual and customary care comparison group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent boys:
  • being 11-13 years old
  • being a patient at a participating University of New Mexico (UNM) Hospital's Envision pediatric practice
  • parental consent for testing, and
  • child assent for testing
  • Parents/Guardians:
  • being a parent/guardian of an eligible and participating 11-13 year old boy
  • demonstrated ability to comprehend study requirements, and
  • providing informed consent for oneself and assent for their youth's participation

排除标准

  • Adolescent boys:
  • another immediate family member is participating in the project (i.e., a sibling)
  • the participant has already received any or all doses for the HPV vaccine, or
  • the participant refuses to assent.
  • Parents/Guardians:
  • under the age of 18, or
  • another immediate family member is participating in the project (i.e., another parent).

结局指标

主要结局

Vaccine Adherence

时间窗: 4 months

Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 3rd dose and date received. Number of participants who received the 3 doses.

Vaccine Initiation

时间窗: 1 Month

Vaccine initiation - whether or not each boy received the HPV vaccine and the date of administration. Number of participants who received at least 1 dose.

次要结局

  • Attitudes towards vaccination in general(Baseline, 3-month follow-up, and 9-month follow-up)
  • Attitudes towards the HPV vaccine(Baseline, 3-month follow-up, and 9-month follow-up)
  • Perception of risk due to HPV and not being vaccinated(Baseline, 3-month follow-up, and 9-month follow-up)
  • Spousal support and social normative and cultural perceptions of receiving the HPV vaccination(Baseline, 3-month follow-up, and 9-month follow-up)
  • Perception of negative and positive consequences associated with HPV vaccination(Baseline, 3-month follow-up, and 9-month follow-up)
  • HPV knowledge(Baseline, 3-month follow-up, and 9-month follow-up)
  • Self-efficacy to make informed decisions about HPV vaccination(Baseline, 3-month follow-up, and 9-month follow-up)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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