The HPV9-10 Trial: Early Initiation of HPV Vaccination

HPV9-10 试验：尽早开始 HPV 疫苗接种

• 批准号: 10612746
• 负责人: ALLISON KEMPE
• 金额: $ 63.45万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10612746
• 关键词: 10 year old; 12 year old; 17 year old; 9 year old; Academy; Adolescence; Adolescent; Adoption; Advisory Committees; Age; American; Audiotape; California; Centers for Disease Control and Prevention (U.S.); Cessation of life; Child; Clinic; Colorado; Communication; Country; Data; Diagnosis; Disease; Goals; Healthy People 2020; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papillomavirus 11; Immune response; Immunity; Immunization; Intervention; Interview; Length; Maintenance; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Morbidity - disease rate; Observational Study; Odds Ratio; Outcome; Parents; Patients; Pediatrics; Perception; Policies; Primary Care; Provider; Public Health; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Reporting; Research Personnel; Retrospective Studies; Safety; Schedule; Series; Sex Behavior; Sexuality; Standardization; Structure; Surveys; Teenagers; Time; Training; Vaccinated; Vaccination; Vaccines; Visit; arm; cancer prevention; cancer therapy; cost; effectiveness evaluation; effectiveness outcome; effectiveness testing; experience; implementation outcomes; interest; member; mortality; novel strategies; pediatrician; practice setting; pragmatic randomized trial; pragmatic trial; prevent; primary outcome; provider communication; randomized trial; recruit; screening; secondary outcome; sex; trial comparing; vaccine acceptance; vaccine refusal; working group

Project Summary The burden of Human Papillomavirus (HPV)-related disease in the US is substantial. A safe and effective vaccine has been available for >10 years, yet the current rate of completion for the HPV series is only 49% for U.S.13-17 year olds. The Advisory Committee on Immunization Practices (ACIP) recommends routine HPV vaccination at age 11-12 years (yrs), but states that the vaccine “can be given starting at age 9 years.” Currently, the majority of pediatricians begin recommending the vaccine at ages 11-12 yrs, however, a recent retrospective study showed that on-time completion rates for HPV vaccine were much higher when the vaccine series was initiated at ages 9-10 compared to ages 11-12 (adjusted odds ratio, 12.8). HPV vaccine should be given prior to sexual activity which occurs earlier than 13 yrs for many teens. There are compelling reasons to think that earlier initiation of vaccination at ages 9-10 might result in higher rates of acceptance of the vaccine and earlier series completion. First, many parents refuse HPV vaccine because they have concerns that vaccination could result in higher promiscuity in early adolescents if the vaccine is discussed in the context of sexuality. Initiation at 9-10 yrs, when few providers discuss sex, could put the focus squarely on cancer prevention, decreasing vaccine refusal. Second, three vaccines are recommended at the 11-12 yr visit, but many parents/adolescents are unwilling to receive all three at one visit. When one of the vaccines is delayed, it is almost always HPV vaccine. Initiation at 9-10 yrs when no other vaccines are given could result in less deferral of vaccination to mid-adolescence and higher rates of vaccination prior to early sexual activity. Finally, initiation at age 9-10 years has been shown to be feasible and, in an observational study, to result in higher rates of on-time series completion. Therefore, we plan to test the effectiveness of shifting initiation of HPV vaccine to 9-10 yrs in a randomized pragmatic trial. Our Specific Aims are to: SA 1: Recruit practices in two states (Colorado and California), randomize in a balanced fashion to recommending HPV vaccine at ages 9-10 yrs or 11-12 yrs and provide standardized training to both arms. SA 2: Conduct a trial to assess effectiveness of early initiation on the 1⁰ outcome of age at HPV series completion; secondary outcomes will examine HPV series completion by age 13 and age at HPV series initiation. SA 3: Examine the effect of earlier initiation on length of time for HPV vaccine discussions and on parent/provider communication about HPV vaccine via audio-taping of visits, audio-elicitation interviews with parents and structured interviews with providers and clinic staff. If earlier HPV initiation is successful in promoting higher HPV series completion by 13 yrs, this intervention could be rapidly disseminated and would have the potential to prevent thousands of cases of HPV-related cancers, their attendant morbidity and mortality as well as the costs of screening, diagnosis and treatment for these cancers yearly.

项目摘要 在美国，人类乳头瘤病毒（HPV）相关的疾病的伯宁很重要。安全有效的 疫苗已经> 10年了，但是HPV系列的目前完成率仅为49％ 美国13-17岁。免疫实践咨询委员会（ACIP）建议常规HPV 11-12岁的疫苗（YRS），但指出该疫苗“可以从9岁开始开始。” 目前，大多数儿科医生开始推荐11-12岁的疫苗 回顾性研究表明，当疫苗时，HPV疫苗的按时完成率要高得多 与11-12岁的年龄相比，序列是在9-10岁时开始的（调整后的优势比，12.8）。 在性活动之前，应给予HPV疫苗，这是许多青少年早于13年前发生的。 有令人信服的理由认为，较早的9-10岁疫苗接种倡议可能会导致更高 接种疫苗的接受率和早期的系列完成。首先，许多父母拒绝HPV疫苗 因为他们担心疫苗接种可能会导致早期青少年的滥交 在性行为中讨论疫苗。在9-10岁时的启动，当几乎没有提供者讨论性行为时， 可以将重点直接放在预防癌症上，减少疫苗拒绝。第二，三疫苗 建议在11-12年的访问中进行 一次访问。当一种疫苗延迟时，几乎总是HPV疫苗。 9-10岁的启动 如果没有其他疫苗，则可能导致疫苗递延至青春期中期，并且 早期性活动之前的疫苗接种率更高。最后，9-10岁的倡议已经 证明是可行的，并且在一项观察性研究中，可以提高按时序列完成率。 因此，我们计划测试HPV疫苗在随机中转移到9-10年的有效性 务实的试验。我们的具体目的是：SA 1：在两个州（科罗拉多州和加利福尼亚州）的招募实践， 以平衡的方式随机进行随机推荐9-10岁或11-12岁的HPV疫苗并提供 两臂的标准化训练。 SA 2：进行试验以评估早期开始对1⁰的有效性 HPV系列完成年龄的结果；次要结果将通过 年龄13岁和HPV系列启动年龄。 SA 3：检查早期倡议对时间长度的影响 HPV疫苗的讨论以及父母/提供者关于HPV疫苗的沟通。 访问，与父母的音频启示访谈以及提供者和诊所工作人员的结构化访谈。如果 较早的HPV启动成功地将更高的HPV系列完成13年，此干预 可能会迅速传播，并有可能预防数千例HPV相关案例 癌症，随之而来的发病率和死亡率以及筛查，诊断和治疗的成本 每年这些癌症。