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.

项目概要 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 疫苗问世已超过 10 年，但目前 HPV 系列的完成率仅为 49% 美国13-17岁。免疫实践咨询委员会 (ACIP) 建议常规接种 HPV 疫苗接种年龄为 11-12 岁 (yrs)，但声明疫苗“可以从 9 岁开始接种”。 目前，大多数儿科医生开始推荐 11 至 12 岁儿童接种疫苗，然而，最近的一项研究 回顾性研究表明，当接种疫苗时，HPV 疫苗的按时完成率要高得多。 系列在 9-10 岁开始，与 11-12 岁相比（调整后的比值比为 12.8）。 HPV 疫苗应在性行为之前接种，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 至 10 岁时尽早开始接种疫苗可能会导致更高的死亡率 疫苗的接受率和早期系列完成情况。一、很多家长拒绝接种HPV疫苗 因为他们担心如果疫苗接种可能会导致青少年早期的乱交情况增加 疫苗是在性的背景下讨论的。 9-10 岁开始，此时很少有提供者讨论性， 可以将重点放在癌症预防上，减少拒绝接种疫苗的情况。二、三联疫苗 建议在 11-12 岁就诊时进行，但许多家长/青少年不愿意在 一次访问。当其中一种疫苗延迟接种时，几乎总是 HPV 疫苗。 9-10岁开始 当不接种其他疫苗时，可能会减少将疫苗接种推迟到青春期中期的情况，并且 早期性行为前的疫苗接种率较高。最后，9-10岁开始 在一项观察性研究中，这被证明是可行的，并且可以提高系列按时完成率。 因此，我们计划在一项随机试验中测试将 HPV 疫苗接种时间推迟到 9-10 岁的有效性。 务实审判。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）进行招聘实践， 以平衡的方式随机推荐 9-10 岁或 11-12 岁的 HPV 疫苗，并提供 双臂标准化训练。 SA 2：进行试验以评估早期启动的有效性 1⁰ HPV 系列完成时的年龄结果；次要结果将检查 HPV 系列的完成情况 13 岁和 HPV 系列启动时的年龄。 SA 3：检查早期启动对时间长度的影响 HPV 疫苗讨论以及家长/提供者通过录音进行有关 HPV 疫苗的沟通 访问、对家长的音频启发式访谈以及对提供者和诊所工作人员的结构化访谈。如果 早期 HPV 启动成功地促进了 13 岁时更高的 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、随之而来的发病率和死亡率以及筛查、诊断和治疗的费用 每年针对这些癌症。