The HPV9-10 Trial: Early Initiation of HPV Vaccination

HPV9-10 试验：尽早开始 HPV 疫苗接种

基本信息

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
项目类别：
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

项目摘要

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安全且有效。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 岁儿童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疫苗接种完成情况首先，许多家长拒绝接种 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 9-10 岁的时候开始讨论的，那时很少有提供者讨论性。可以将重点放在癌症预防上，减少拒绝接种第二、三种疫苗。建议在 11-12 岁就诊时进行，但许多家长/青少年不愿意在当其中一种疫苗延迟接种时，几乎总是在 9-10 岁开始接种。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，并且最后，在 9 至 10 岁时开始接种疫苗。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。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）招募实践人员，以平衡的方式随机推荐 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 的有效性。 HPV 系列完成时的年龄结果；次要结果将检查 HPV 系列完成情况 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。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。