The HPV9-10 Trial: Early Initiation of HPV Vaccination

项目摘要 在美国，人类乳头瘤病毒(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10年了，但目前HPV系列疫苗的完成率仅为49% 美国13-17岁的青少年。免疫实践咨询委员会(ACIP)建议常规HPV 在11-12岁(岁)接种疫苗，但声明疫苗“可以从9岁开始接种”。 目前，大多数儿科医生在11-12岁时开始推荐接种疫苗，然而，最近的一项调查显示 回顾研究表明，当接种HPV疫苗时，按时完成率要高得多 该系列在9-10岁开始，而11-12岁(调整后的优势比为12.8)。 HPV疫苗应该在性行为之前接种，对于许多青少年来说，性行为发生在13岁之前。 有令人信服的理由认为，在9-10岁早期开始接种疫苗可能会导致更高的 疫苗接受率和更早的系列完成率。首先，许多父母拒绝接种HPV疫苗 因为他们担心接种疫苗可能会导致早期青少年更高的滥交，如果 疫苗是在性行为的背景下讨论的。在9-10岁，很少有提供者讨论性的时候开始， 可以将重点直接放在癌症预防上，减少疫苗拒绝接种。第二，三种疫苗 建议在11-12岁就诊时使用，但许多家长/青少年不愿在 一次拜访。当其中一种疫苗被推迟时，几乎总是HPV疫苗。入会时间为9-10年 如果不接种其他疫苗，可能会导致较少的疫苗接种推迟到青春期中期和 在早期性活动前接种疫苗的比率较高。最后，9-10岁的印心是 显示是可行的，并在观察性研究中，导致更高的按时序列完成率。 因此，我们计划在随机试验中测试将hpv疫苗接种时间改为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(科罗拉多州和加利福尼亚州)招募实践， 以均衡的方式随机推荐9-10岁或11-12岁的HPV疫苗，并提供 对双臂进行标准化训练。SA 2：进行试验以评估早期启动1⁰的效果 HPV系列完成时的年龄结果；二次结果将检查HPV系列完成情况 13岁和HPV系列入门年龄。SA 3：检查提早入门对时间长度的影响 HPV疫苗讨论和家长/提供者通过录音就HPV疫苗进行的沟通 探访，与父母进行音频启发访谈，以及与提供者和诊所工作人员进行有组织的访谈。如果 更早启动HPV成功地将HPV系列的完成率提高了13年，这一干预措施 可以迅速传播，并有可能防止数千例与HPV相关的病例 癌症及其伴随的发病率和死亡率以及筛查、诊断和治疗的费用 这些癌症每年都有。

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.