The STOP-HPV Scale Up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with a participating provider during the intervention period.
研究概览
简要总结
Human papillomavirus (HPV) causes 35,900 US cancer cases per year, 4,000 deaths, and $4 billion in can In this study, the investigators will conduct a 3-arm clustered randomized controlled trial (RCT) in an estimated 72 practices from up to 8 health systems to evaluate the effectiveness and cost effectiveness of two potentially scalable implementation strategies (based on prior work) to increase the initiation of HPV vaccine against a usual care (control) arm. The intervention arms are 1) online provider communication training only ("STOP-HPV-Online" and 2) online provider communication training plus a Learning Collaborative, with performance feedback, attended by practice leads ("STOP-HPV-LC).
cer-related costs. It is recommended at ages 11-12 years routinely but can be given starting at ages 9-10 years. Despite having an effective vaccine, HPV vaccine initiation/completion rates in the U.S. were only at 76.8%/61.4% respectively in 2023 among 13-17 year olds; these rates are lower than the other recommended adolescent vaccines. Two key barriers are 1) suboptimal clinician communication to address parental concerns and 2) ineffective office systems causing missed vaccine opportunities.
详细描述
In prior work, the investigators have tested two implementation strategies/interventions that were effective, but which were deployed by the research team. The first is provider communication training ("STOP-HPV-Online"), delivered by the research team, in a cluster RCT in 48 pediatric practices from a research network (6.8% improvement in initiation). The other is a quality improvement, pre-post study, that included both provider communication training, as well as a Learning Collaborative (LC) for practice leads (8% increase in initiation).
A major challenge in implementation science and spreading practice-based strategies is to move from research teams deploying implementation strategies (intervention) to health systems deploying them. In this study, the investigators will compare the effectiveness and cost-effectiveness of the two implementation strategies (interventions) using a 3-arm clustered RCT: 1) STOP-HPV-Online vs 2) STOP-HPV-LC vs 3) usual care. The study team will randomize an estimated 72 practices (from up to 8 health systems) to the 1) STOP-HPV-Online arm, 2) the STOP-HPV-LC arm or 3) the control arm, assess fidelity to the intervention and conduct the evaluation. A collaborating organization, AMGA (the American Medical Group Association), will facilitate training of the health system personnel, as needed; however, the health systems will deploy each intervention. The primary outcome measure is the initiation rate among 9-<13 year olds with a well-child care visit during the 12 month intervention period (with inclusion starting at the time of a well child care visit during the intervention period). A secondary outcome measure will be the initiation rate among 13-17 year olds with a well child care visit during the intervention period (with inclusion starting at the time of a well child care visit during the intervention period. For both measures, inclusion criteria will be: 1) presenting to a participating practice, 2) age eligible at the visit and 3) no prior vaccine at the time of the visit.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 卫生服务研究
- 盲法
- 开放(无盲法)
入排标准
- 年龄范围
- 9 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Patient of participating practice
- Well child care visit during the 12-month intervention period
- No prior dose of HPV vaccine at the time of the well child care visit
- Age-eligible
排除标准
- Prior dose of HPV vaccine
研究组 & 干预措施
Usual Care
Standard of care control
STOP-HPV Online
Provider communication training
干预措施: STOP-HPV-Online (Behavioral)
STOP-HPV LC
Provider communication training plus Learning Collaborative sessions attended by practice leads and quarterly performance feedback to the practice.
干预措施: STOP-HPV-LC (Behavioral)
结局指标
主要结局
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with a participating provider during the intervention period.
时间窗: 12 months from start of intervention
The percent of children ages 9-\<13 years of age who received their first dose of HPV vaccine at or following a well child care visit with a participating provider during the intervention-period (denominator is children ages 9-\<13 with a well child visit during the study period at which they were due for their first dose).
次要结局
- Total implementation cost(12 months from start of intervention)
- Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with any provider during the intervention period.(12 months from start of intervention)
- Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with a participating provider during the intervention period.(12 months from start of intervention)
- Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with any provider during the intervention period.(12 months from start of intervention)
- Total implementation cost(12 months from start of intervention)
研究者
Peter G Szilagyi, MD MPH
Professor
University of California, Los Angeles
研究点 (1)
标识符
- NCT 编号
- NCT06831383
- 其他研究编号
- 23-000022, 1R01CA276151-01
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (6个月后)
- 研究完成日期
- (6个月后)
- 最近核实
- (8个月前)
- 最近更新
- (4个月前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否
