The HPV9-10 Trial: Early Initiation of HPV Vaccination

项目摘要 在美国，人乳头瘤病毒（HPV）相关疾病的负担是巨大的。一种安全有效的 疫苗已经上市超过10年，但目前HPV系列的完成率仅为49%， 美国13 -17奥尔兹。免疫实践咨询委员会（ACIP）建议常规HPV 在11-12岁接种疫苗，但指出疫苗“可以从9岁开始接种”。 目前，大多数儿科医生开始建议在11-12岁时接种疫苗，然而，最近 一项回顾性研究表明，当疫苗接种时，HPV疫苗的按时完成率要高得多， 与11-12岁相比，该系列在9-10岁开始（调整后的比值比为12.8）。 HPV疫苗应该在性活动之前接种，对于许多青少年来说，性活动发生在13岁之前。 有令人信服的理由认为，在9-10岁时更早开始接种疫苗可能会导致更高的 疫苗的接受率和较早的系列完成率。一、很多家长拒绝HPV疫苗 因为他们担心，如果接种疫苗， 疫苗是在性的背景下讨论的。在9-10岁开始，当很少有提供者讨论性， 可以把重点放在癌症预防上，减少疫苗拒绝。二、三种疫苗 建议在11-12岁的访问，但许多父母/青少年不愿意接受所有三个在 一次拜访。当其中一种疫苗被推迟接种时，几乎总是HPV疫苗。9-10岁时开始 当没有其他疫苗接种时，可能会导致疫苗接种推迟到青春期中期， 早期性活动前的疫苗接种率较高。最后，在9-10岁开始， 在一项观察性研究中，这一方法被证明是可行的，并导致按时完成序列的比率更高。 因此，我们计划在一项随机研究中测试将HPV疫苗接种开始时间改为9-10年的有效性。 务实的审判我们的具体目标是：SA 1：在两个州（科罗拉多和加州）的招聘实践， 以平衡的方式随机推荐9-10岁或11-12岁的HPV疫苗，并提供 两种武器的标准化训练。SA 2：进行一项试验，以评估在1周内早期启动的有效性 HPV系列完成时的年龄结局;次要结局将检查HPV系列完成情况， 13岁和HPV系列开始时的年龄。SA 3：检查较早开始对时间长度的影响 HPV疫苗讨论和父母/提供者通过录音关于HPV疫苗的沟通 访问，与父母的音频诱导访谈以及与提供者和诊所工作人员的结构化访谈。如果 较早的HPV启动成功地促进了13年的HPV系列完成，这种干预措施 可以迅速传播，并有可能预防数千例HPV相关病例。 癌症及其伴随的发病率和死亡率以及筛查、诊断和治疗费用 这些癌症的发病率

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.