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临床试验/NCT02370459
NCT02370459已完成不适用

Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
223
试验地点
4
主要终点
HPV vaccination (≥1 dose), 11-12 year olds

研究概览

简要总结

The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics overall. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.

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
是

入选标准

  • •Pediatric or family medicine clinics or practices in WA, IL, or MI with
  • •at least 500 active records for patients, ages 11-17, in their states' immunization information systems.

排除标准

  • 未提供

研究组 & 干预措施

control

No Intervention

This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive no AFIX consultation.

AFIX in-person consultation

Experimental

This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive an in-person AFIX consultation. Consultations will be delivered by state health department staff.

干预措施: AFIX in-person consultation (Other)

AFIX webinar consultation

Experimental

This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90. Clinics randomly assigned to this arm will receive an AFIX consultation via interactive webinar. Consultations will be delivered by state health department staff.

干预措施: AFIX webinar consultation (Other)

结局指标

主要结局

HPV vaccination (≥1 dose), 11-12 year olds

时间窗: Six months

Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by electronic immunization information system (IIS) records, controlling for child's sex

次要结局

  • HPV vaccination (≥1 dose), 13-17 year olds(Twelve months)
  • HPV vaccination (3 doses), 13-17 year olds(Twelve months)
  • Tdap vaccination, 13-17 year olds(Twelve months)
  • Meningococcal vaccination (≥1 dose), 13-17 year olds(Twelve months)
  • Tdap vaccination, 11-12 year olds(Twelve months)
  • HPV vaccination (≥1 dose), 11-12 year olds(Twelve months)
  • HPV vaccination (3 doses), 11-12 year olds(Twelve months)
  • Meningococcal vaccination (≥1 dose), 11-12 year olds(Twelve months)
  • Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds(Six months)
  • HPV vaccination (≥1 dose), 11-12 year olds(Six months)
  • HPV vaccination (3 doses), 11-12 year olds(Six months)
  • Meningococcal vaccination (≥1 dose), 11-12 year olds(Six months)
  • HPV vaccination (≥1 dose), 13-17 year olds(Six months)
  • HPV vaccination (3 doses), 13-17 year olds(Six months)
  • Tdap vaccination, 13-17 year olds(Six months)
  • Meningococcal vaccination (≥1 dose), 13-17 year olds(Six months)
  • Tdap vaccination, 11-12 year olds(Six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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