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临床试验/NCT02535845
NCT02535845终止不适用

Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
2
主要终点
HPV Vaccination Behavior Documented in Electronic Health Record, Initiation

研究概览

简要总结

HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Self-persuasion, generating one's own arguments for engaging in a behavior, may be an effective means to influence parents' motivation to vaccinate their children. In a three-phase study, investigators are using quantitative and qualitative research methods to develop and refine a tablet-based self-persuasion intervention for parents who are undecided about the HPV vaccine. This clinical trial submission focuses on the third phase of the study (the second stage is also registered in clinical trials).

详细描述

Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine coverage among adolescents age 13-17 is poor (60% for girls, 41.7% for boys). HPV-related cancers are a significant burden on the US healthcare system and could be prevented through adolescent vaccination. Rates of vaccination are suboptimal among underserved populations (uninsured, low-income, racial and ethnic minorities) often seen in safety-net clinics. Few interventions have been designed that target decision-making among parents of unvaccinated adolescents. Self-persuasion, generating of one's own arguments for a health behavior, may be an effective means of influencing HPV vaccination behaviors among undecided or ambivalent parents. Through three stages, investigators will identify and develop a self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. In Stage 3, reported here, investigators will conduct a two-arm pilot randomized control trial in the safety-net clinics to assess feasibility of testing the self-persuasion intervention condition against standard of care (control group). Parent-adolescent child dyads will be enrolled. Parents will be exposed to the intervention and the primary outcome (HPV vaccination) will be assessed on the adolescent child via the electronic health record. Investigators will also examine the impact of the intervention on parent-provider discussions about HPV vaccination.

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 (Care Provider)

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

  • 未提供

排除标准

  • Parents: Having impairing hearing or speech
  • Adolescents: pregnant at the time of the clinic visit
  • Dyad: participated in Phase 1 and 2 of the study

结局指标

主要结局

HPV Vaccination Behavior Documented in Electronic Health Record, Initiation

时间窗: 30 days

Number of parents who decided to start the HPV vaccine three dose series and got their child vaccinated within 30 days of the study appointment as evidenced by documentation in the child's electronic medical record.

次要结局

  • HPV Vaccination Behavior Documented in Electronic Medical Record, Completion(15 months)
  • Active Parent Participation During Clinical Encounter(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jasmin A. Tiro

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (2)

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