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临床试验/NCT02377843
NCT02377843已完成不适用

Making Effective HPV Vaccine Recommendations

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds

研究概览

简要总结

Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A central reason for low coverage is infrequent and inadequate healthcare provider recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide effective recommendations for the vaccine using participatory or efficient communication strategies.

This study will evaluate the effectiveness of two communication trainings to increase HPV vaccination coverage among adolescent patients. We will compare HPV vaccination for pediatric and family medicine clinics receiving a participatory communication training, efficient communication training, or no training. Ten clinics will be randomly assigned to each study arm for a total of 30 clinics. The primary outcome of this study is to compare the change in clinics' levels of HPV vaccination initiation coverage among 11-12 year old adolescent patients from baseline to 6 month follow-up. Secondarily, we will compare the change in HPV vaccination initiation coverage in 13-17 year old adolescents.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible clinics are pediatric and family medicine practice clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics must have at least one pediatric or family medicine physician who provides HPV vaccine to adolescents ages 11-12.

排除标准

  • Ineligible clinics include those that have participated in a quality improvement study to increase HPV vaccination rates in the last 6 months or plan to participate in such a study in the next 6 months.

结局指标

主要结局

6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds

时间窗: Baseline, month 6

Analysis controlling for sex. Vaccination as measured by North Carolina Immunization Registry (NCIR).

次要结局

  • 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds(Baseline, month 6)
  • 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds(Baseline, month 3)
  • 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds(Baseline, month 3)
  • Change in clinician self-efficacy, efficient arm vs. participatory arm(Pre-training, Post-training, week 2)
  • 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females(Baseline, month 3)
  • 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males(Baseline, month 3)
  • 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds(Baseline, month 3)
  • 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds(Baseline, month 6)
  • 3 month % change in tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, control arm vs. each intervention arm, 11-12 year olds(Baseline, month 3)
  • 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds(Baseline, month 6)
  • 3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds(Baseline, month 3)
  • 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds(Baseline, month 3)
  • Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory(Pre-training, Post-training, week 2)
  • 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females(Baseline, month 6)
  • 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males(Baseline, month 6)
  • 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males(Baseline, month 6)
  • 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females(Baseline, month 3)
  • 6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds(Baseline, month 6)
  • 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds(Baseline, month 6)
  • 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds(Baseline, month 3)
  • 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds(Baseline, month 3)
  • 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds(Baseline, month 6)
  • 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females(Baseline, month 6)
  • 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds(Baseline, month 6)
  • 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds(Baseline, month 6)
  • Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm(Pre-training, Post-training)
  • 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males(Baseline, month 6)
  • 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males(Baseline, month 3)
  • 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females(Baseline, month 6)
  • 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males(Baseline, month 3)
  • Change in clinician recommendation quality, efficient arm vs. participatory arm(Pre-training, week 2)
  • Change in clinician communication of routine use, efficient arm vs. participatory arm(Pre-training, Post-training, week 2)
  • 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females(Baseline, month 3)
  • 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males(Baseline, month 3)
  • 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females(Baseline, month 3)
  • 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females(Baseline, month 6)
  • 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males(Baseline, month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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