Learning Objectives 12/9/2015. HPV Vaccine and Provider Parent Communication REFRAMING THE HPV VACCINE JUST ANOTHER SHOT:

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1 From the MINNESOTA Department of Health Y JUST ANOTHER SHOT: REFRAMING THE HPV VACCINE HPV Vaccine and Provider Parent Communication Sharon Humiston, MD, MPH, FAAP Professor of Pediatrics Children s Mercy Kansas City, MO This work was funded by a grant from the CDC. Learning Objectives 1. List the recommendations for HPV vaccination for girls and for boys. 2. Identify and implement the same way, same day approach to HPV vaccination for all 11 & 12 year olds in the pediatric health care setting. 3. Model evidence based communication approaches when talking with 11 and 12 year olds and their parents about the importance of HPV vaccine. 4. Introduce >2 new practice tools to help support HPV vaccination in the pediatric health care setting. 1

2 The Primary Care Perspective Objective #1 CDC S RECOMMENDATIONS & THEIR RATIONALE Genital Warts Initial visits to physicians office, US, The OB GYN Perspective 2

3 HPV is the most common STI (Note, this is not to scale!) Persistent HPV infection is associated with malignancy HPV genome encodes proteins that regulate viral replication, transcription, and alter growth. These proteins can introduce instability in the genome of infected cells. HPV Associated Cervical Cancer Incidence Rates by State, United States, Complications related to current methods of cervical cancer 2ndary prevention Infertility due to treatment of cervical cancer by hysterectomy Cervical conization and loop electrosurgical excision procedure (LEEP) are associated with adverse obstetric morbidity Subsequent pregnancies are at risk of Perinatal mortality Preterm delivery severe, extreme Low birth weight severe, extreme These outcomes have a large effect on the mothers & infants concerned and on the cost of NICU care With vaccination, many relevant HPV infections become preventable The ENT Perspective Attribution of HPV types in common HPV related cancers, US Data Overall improvement in cancer prevention for 9 valent vaccine over quadrivalent and bivalent: 14% for females, 5% for males What is the oropharynx? 3

4 Oropharyngeal Cancer If recent incidence trends continue, the annual # of HPV positive oropharyngeal cancers is expected to surpass the annual # of cervical cancers by the year J Clin Oncol 29: by American Society of Clinical Oncology SIGN: Raising money for oral cancer research Oral vs Oropharyngeal (OP) Cancer Incidence OP cancers increasing Risks Compared to oral cancer patients, OP cancer patients are more likely to be Younger Non smoker European American In a higher socioeconomic status And to have an HPV associated cancer HPV 60 80% of OP cancers are HPV positive, most commonly types HPV 16 and HPV 18 How is OP cancer discovered? No PAP like test; inspection for spread to nodes Typically, present with sore throat or neck mass (e.g., swelling they noticed while shaving) Occasionally, present with a cystic neck mass easily confused with unimportant benign cyst Refer any adult with a sore throat or neck mass that does not resolve w/in 2 weeks Oral, Head & Neck Cancer Awareness Week in April, get a free OP cancer exam at hundreds of US sites (OHANCAW.com) OP Cancer Treatment: Good News, Bad News Treatment depends on cancer stage Early stage cancers, either radiation alone or surgery alone Advanced staged cancers require combinations of either surgery followed by radiation or concomitant chemotherapy + radiation therapy Side effects of treatment can be extensive and disruptive (e.g., loss of saliva, loss of teeth, speech pathology, damage to carotids or vital support of shoulder) Attribution of HPV types in common HPV related cancers, US Data HPV prophylactic vaccines A large proportion of the HPV types that cause OP cancer are covered by HPV vaccines Recombinant L1 capsid proteins that form virus like particles (VLP) Non infectious and non oncogenic Produce higher levels of neutralizing antibody than natural infection HPV Virus Like Particle 4

5 Updated ACIP Recommendations Age Routine vaccination at age 11 or 12 years (as early as age 9 years) Vaccination recommended through age 26 for females and through age 21 for males not previously vaccinated Vaccination recommended for men through age 26 who have sex with men (MSM) or are immunocompromised (including persons HIV infected) Formulation by gender (assuming availability) 9vHPV 4vHPV 2vHPV Females Males 25 Adolescent (ages 13 17) Vaccination Coverage, U.S., * NIS-Teen MMWR 2014; 63(29); HPV girls means At least 1 dose of HPV vaccine among females years of age HPV Vaccine Series Initiation Girls Years, by State, 2013 Rationale for HPV vaccination at years of age Antibody responses are highest at ages 9 through 15 years. Optimal vaccine efficacy if the vaccine series is completed before onset of sexual activity The vaccine is inactive against previously acquired HPV types. Protection appears to be long lasting Rationale for vaccinating early: Protection prior to exposure to HPV About 50% of people are infected with HPV within 12 months of sexual debut HPV Vaccine Provides Safe, Effective, and Long Lasting Protection HPV Vaccine WORKS Prevalence of vaccine types declines by more than half in U.S. (33% of teens fully vaccinated) High grade cervical lesions decline in Australia (80% of school aged girls vaccinated) HPV Vaccine LASTS Studies suggest that vaccine protection is long lasting; no evidence of waning immunity HPV Vaccine is SAFE Safety studies findings for HPV vaccine similar to safety reviews of MCV4 and Tdap vaccines Garland et al, Prev Med 2011; Ali et al, BMJ 2013; Markowitz JID 2013; Nsouli-Maktabi MSMR

6 Prevalence of HPV 6, 11,16, 18* in Cervicovaginal Swabs, by Age Group, NHANES, and , U.S. Prevalence (%) % decline Impact of HPV vaccination in Australia Proportion of Australian born females & males diagnosed with genital warts at 1st visit, by age group, Females Males Age group (years) *weighted prevalence Markowitz, et al. Reduction in HPV prevalence among young women following HPV vaccine introduction in the United States, NHANES, J Infect Dis Ali, et al., Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. British Med J 2013;346:f Studies on Gardasil (vs unvaccinated) have shown that vaccinated females are not more likely to develop: 2011 allergic reactions, anaphylaxis, Guillain Barré Syndrome, stroke, blood clots, appendicitis, or seizures (than unvaccinated or who received other vaccines) 2013 (almost 1 million girls) blood clots or AEs related to the immune & CNS 2014 (>1 million women) venous thromboembolism or blood clots 2012 and 2014 (2 studies) autoimmune disorders 2015 MS or similar diseases 2012 vaccine may be associated with skin infections where the shot is given during the two weeks after vaccination and fainting on the day the shot is received Objective #2 SAME DAY, SAME WAY The Opener Announce the child needs 3 vaccines (4 if flu vaccine is available) Encourage convenient same day vaccination Today, Pat should have 3 vaccines. They re designed to protect him from the cancers caused by HPV and from meningitis, tetanus, diphtheria, & pertussis. Do you have any questions for me? If a parents hesitates, the MA/nurse should say Our team is so dedicated to cancer prevention. I m sure the doctor will want to respond to your concerns. Be sure everyone in the office understands the mission Human stories often influence people more than statistics To understand the human stories behind HPV, listen to survivors Shot By Shot Unprotected People on 6

7 How we recommend childhood vaccines As a package of protection With a full understanding of and conviction in each vaccine s importance Mening, HPV, and Tdap all on one day Objective #3 EVIDENCE BASED APPROACHES TO COMMUNICATION If a parent were hesitant Ask Acknowledge Advise Clarify & restate their concerns to make sure you understand. It s the parents decision and responsibility You are on the same side wanting to protect this child, not just public health Be willing to discuss parents ideas. Offer written resources for parents. Tailor your advice using this sheet or CDC s Tips & Time Savers. s/for-hcp-tipsheet-hpv.html 7

8 If a parent declines Declination is not final. The conversation can be revisited. End the conversation with at least 1 action you both agree on. Because waiting to vaccinate is the risky choice, many physicians ask the parent to sign a Declination Form efusaltovaccinate.pdf Another Model: CASE Corroborate/ Acknowledge About me (what I ve done to study this) Science Explain/ Advise Model #3: Motivational Interviewing Being studied by Amanda Dempsey, MD, PhD A way of being with the client, not just a set of counseling techniques (Miller & Rollnick, 1991) Provider becomes a helper in the change process Works to strengthen a person s intrinsic motivation for a behavior More about the words you use than the underlying goal In response to a parent supportive of vaccination but with HPV safety concerns: Instead of: Actually, studies show that there are no serious side effects from the vaccine so I think you should let your daughter get it. It s really important. Coming to Yes : It sounds like you are generally in support of vaccines, but you have concerns about the safety of HPV. Is that right? So if you had information that convinced you the HPV vaccine was safe you might consider letting your daughter have it? Would it be OK if I shared what I know about the safety of the vaccine? Balancing Communication Styles Start with a presumptive bundled recommendation If not met with acceptance, use other tools MI type conversations Fact sheets Decision Aids And most importantly DON T GIVE UP! 8

9 Would we ever present a routinely recommended vaccine this way? Profiling does not work. Do I really want to bet someone s life on guessing right? Of course, not! Who Makes the HPV Decision? Cross sectional sample of women in SE Texas With >1 child age 9 17 yrs in Objective 4 31% 24% PRACTICE TOOLS Effect of the Decision-making Process in the Family on HPV Vaccination Rates among Adolescents 9-17 years of age. Human Vaccine Immunotherapy For more information, including free resources for yourself and your patients/clients, visit: cdc.gov/vaccines/youarethekey questions or comments to CDC Vaccines for Preteens and Teens: PreteenVaccines@cdc.gov For More Information Shot by Shot gallery AAP Info for parents (healthychildren.org) Info for clinicians ( immunization/illnesses/hpv/hpv.html) Immunization Action Coalition CHOP Vaccine Education Center EZ IZ 9

10 Which areas had large, significant increases in HPV immz rates (females) from ? At least 1 dose Chicago, IL DC Illinois Montana North Carolina Utah MMWR / July 31, 2015 / Vol. 64 / No. 29 Which areas had large, significant increases in HPV immz rates (females) from ? At least 1 dose Chicago, IL DC Illinois Montana North Carolina Utah At least 3 doses Chicago, IL DC Illinois Montana North Carolina Georgia MMWR / July 31, 2015 / Vol. 64 / No. 29 Range of 1 Year Percentage Point Increase At least 1 dose Chicago, IL 13.2 DC 22.8 Illinois Montana North Carolina Utah At least 3 doses Chicago, IL DC 28.6 Illinois Montana North Carolina Georgia 14.5 MMWR / July 31, 2015 / Vol. 64 / No. 29 Provider Prompts: QI Post Vaccination Syncope (PVS) Serious injuries have occurred from PVS ACIP recommends that vaccine providers should strongly consider observing patients for 15 minutes after they are vaccinated. If syncope develops, patients should be observed until the symptoms resolve. Among the 41 PVS reports with secondary injuries and info about the timing of syncope: 76% occurred in adolescents aged 11 to 18 years Time from vaccination to syncope onset was <5 minutes in 49%, <15 minutes in 80% of the reports 10 of the 41 (24%) sustained injuries that were serious 10

11 Postural Orthostatic & Tachycardia Syndrome (POTS) As of May 1, 2015, the Vaccine Adverse Event Reporting System (VAERS) received 59 US reports with diagnosis POTS 41 reports after HPV4 vaccine (alone or with other) 18 reports no HPV vaccine, only other vaccine (Some cases were inconsistent with POTS and some did not have enough information to definitely make a diagnosis of POTS from the report.) Since the # of VAERS reports for POTS was higher after HPV than other vaccines, government scientists did a detailed review of all cases of POTS reports did not find an indication of a possible causal association The End Thank you for watching! Questions? On Demand Evaluation 11