NCT04945655已完成不适用
Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability Among French Adolescents: a Cluster Randomized Controlled Trial
Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 30,739 人开始时间: 2021年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30,739
- 试验地点
- 1
- 主要终点
- HPV vaccine coverage (≥ 1 dose)
研究概览
简要总结
This study aims at evaluating the effectiveness, efficiency and implementation of a multicomponent intervention (components being applied in combination or alone) on the acceptability of HPV vaccine among French adolescents (11-14 years old) through a cluster randomized controlled trial. The primary outcome to measure acceptability is vaccine coverage. The three components are: adolescents and parents' education and motivation at school (component 1); general practitioners' training (component 2); and access to vaccination at school (component 3). Ninety municipalities are included and randomized into six groups of 15 municipalities, according an incomplete factorial plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents and parents' education and motivation at school (component 1 -- arms 1-4) and "KABP-6C" survey among adolescents and parents (arms 1-6)
- •Inclusion Criteria:
- •Adolescents (school years 9-10), and parents of adolescents (school years 7-10) attending secondary schools in the participating municipalities.
排除标准
- •General practitioners' training (component 2) and "KABP-6C" survey among general practitioners (arms 1, 2 and 5)
- •Inclusion Criteria:
- •General practitioners' practicing in the participating municipalities.
- •Exclusion Criteria:
- •Exclusive particular type of practice.
- •Planning to retire or move their practice within the study period.
- •No internet access.
- •Access to vaccination at school (component 3 -- arms 1 and 3)
- •Inclusion Criteria:
- •Adolescents (school years 7-10) attending secondary schools in the participating municipalities, aged 11-14 years (with a possible catch-up for those aged 15-19 years according to the French recommendations).
- •Exclusion Criteria:
- •Having initiated HPV vaccination.
- •No written consent from parents/caregivers for vaccination.
- •Contraindication to HPV vaccination.
结局指标
主要结局
HPV vaccine coverage (≥ 1 dose)
时间窗: 2 months after intervention
Percentage of adolescents aged 11-14 years, living in the municipality, who have received at least one dose of HPV vaccine
次要结局
- HPV vaccine coverage (≥ 1 dose)(6 months and 12 months after intervention)
- HPV vaccine coverage (2 doses)(2 months, 6 months and 12 months after intervention)
- HPV vaccination intention(Before intervention and 2 months after intervention)
- Intervention components' adaptation(Intervention components' implementation period)
- Satisfaction of target populations about the activities / tools, assessed by a 4-point Likert scale(End of the intervention components' implementation period)
- Knowledge, attitude, beliefs and practices towards HPV vaccination and psychological determinants of vaccination intention ("KABP-6C")(Before intervention and 2 months after intervention)
- Incremental Cost-Effectiveness Ratio(2 months after intervention)
- Reached populations(Intervention components' implementation period)
- Intervention components' dose and fidelity(Intervention components' implementation period)
研究者
研究点 (1)
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