Making a Strong Recommendation About HPV Vaccine to Parents in Primary Care Based on the slides created by Jill B. Roark, MPH for the CDC’s HPV Speaker’s Bureau APA’s National Partnership for Adolescent Immunization (NPAI) Learning Collaborative 2014 Funded by a grant from CDC NCIRD National Partnership for Adolescent Immunization (NPAI) PI: Peter Szilagyi Coordinators: Christina Albertin, Nui Dhepyasuwan FACULTY & CONSULTANTS Donna D'Alessandro Ed Marcuse (communication expert) William Atkinson Cindy Rand Paul Darden Stanley Schaffer Sharon Humiston (moderator) Janet Serwint Keith Mann William Stratbucker Will Findlay, Instructional Design Introduction HPV vaccine is an important routinely recommended vaccine that is underutilized. If it were given with the other routine vaccines with the same strength of provider recommendation – it is likely that more people would be protected. This talk is designed to give you: 1. A practical immunization communication strategy 2. Accurate and succinct answers to FAQs about HPV vaccination 3. Tips on having your whole office team feel comfortable communicating about HPV vaccine Recommend Objective #1 A PRACTICAL IMMUNIZATION COMMUNICATION STRATEGY Recommend-Ask-Acknowledge-Advise approach: Is a framework for the immunization conversation Was developed by Vax Northwest – a Seattlebased collaborative Is stepwise, based on reactions specific to the family Has focused on and been tested in preschool (not adolescent) immunizations. We recognize that adolescent immunization is different (e.g., need for assent). Because we are emphasizing the 11-12 year old visit, we highlight interactions with the parent, but the adolescent should be an integral part of the conversation! Recommend Introduce the topic by clearly stating your recommendations for the immunizations that are due today. Treat HPV just like the other routinely recommended adolescent immunizations. I think Quinn should get 3 shots today: HPV vaccine, meningococcal vaccine and Tdap vaccine. I think Michelle should have 3 shots today that will protect her from the cancers caused by HPV, and infections causing meningitis, whooping cough, tetanus, & diphtheria. 7 Ask (Use open-ended questions) Ask what questions they have about the vaccines or the schedule. What questions do you have for me about these vaccines? Clarify and re-state their concerns to make sure you understand. It sounds like you’re concerned that the HPV vaccine isn’t necessary because Emily is a virgin. Am I understanding this? 8 Acknowledge – Strategy for “Accepting Parent” Support the parent’s decisions to follow the recommended schedule. I think staying up to date with the adolescent vaccines is a great step to take. Keeping Sophie up to date on vaccines is the single most important way our office can work with your family to keep her protected from serious diseases. 9 Acknowledge – Strategy for “Hesitant Parent” Acknowledge the parent's concerns There are a lot of different opinion about vaccines and a lot of conflicting information… Make clear your goal is the same as the parents I know you want to do everything you can to keep Sophie safe, and so do I Name the emotions you observe Be clear that you are concerned for the health of the adolescent, not just public health safety 10 Advise • Address the parent's specific concerns • Offer to assist them to get information relevant to their concerns • Allow them time to reflect, consult with their spouse/partner • Provide them with an opportunity to revisit their concerns with you • Develop a plan that is acceptable to the parent, noting you understand that the decision and burden of responsibility is theirs • Schedule a follow-up appointment 11 1. Why is this vaccine needed? 2. Is HPV important? • If a woman gets regular PAP smears she won’t get cervical cancer. • My son won’t get cervical cancer so why bother with this? 3. Isn’t the HPV vaccine too new to know if it works? 4. Is HPV vaccine safe? 5. Why give this at 11 or 12 years of age? 6. Will my child see this as “permission” to have sex? 7. Would you give HPV vaccine to your child? Objective #2 ACCURATE AND SUCCINCT ANSWERS TO FAQS ABOUT HPV VACCINATION For each question we will give you a detailed answer with references and some sample “scripts” for use with parents. FAQ 1: Why is this vaccine needed? In focus groups, some moms: Stated that they didn’t think HPV infection was very common because They had never heard that it was or They didn’t know anyone who had an HPV infection or HPV disease Some moms couldn’t understand how their child could become infected even if they waited until marriage to have sex U.S. HPV Prevalence & Incidence US statistics Currently infected ~79 million New infections/year ~14 million HPV infection is most common in people in their teens and early 20s HPV is the most common STI …but most people never know that they have been infected -- unless a woman has an abnormal pap test with a positive HPV test Jemal A et al. J Natl Cancer Inst 2013;105:175-201 HPV Transmission HPV exposure can occur with any type of intimate sexual contact. Among a cohort of adolescent women without prior vaginal intercourse (followed longitudinally): HPV was detected in 46% of females prior to 1st vaginal sex 70% of these women reported non-coital behaviors that may in part explain genital transmission Vaginal intercourse is not necessary to become infected Condoms do not completely stop HPV transmission Jemal A et al. J Natl Cancer Inst 2013;105:175-201 Transmission During Intercourse Nearly 50% of high school students have already engaged in sexual (vaginal-penile) intercourse 1/3 of 9th graders and 2/3 of 12th graders have engaged in sexual intercourse 24% of high school seniors have had sexual intercourse with 4 or more partners About 50% of people are infected with HPV within 12 months of sexual debut Jemal A et al. J Natl Cancer Inst 2013;105:175-201 Winer RL, Lee SK, Hugh JP, et al. Am J Epidemiolog 2003. 157:218-226. Try saying: The virus can spread without intercourse. Even virgins can be infected with HPV. HPV is so common that almost everyone will be infected at some point. Yet most people never know that they have had an HPV infection. Even if your child waits until marriage to have sex, he/she could still be exposed if his/her future partner engaged in any type of sexual activity before marriage. About 79 million Americans are infected with HPV and there are 14 million new infections each year. FAQ 2: Is HPV important? In focus groups and online panels, mothers wanted more information on the types of HPV cancers In focus groups mothers stated they were influenced to vaccinate their child because HPV vaccine prevents cancer They had a family history of gynecological cancers (cervical, ovarian), and/or They had a personal experience with cervical cancer FAQ 2 (female): Is HPV important? If a woman gets regular PAP smears she won’t get cervical cancer. Cervical Cancer Cervical cancer is the most common HPV-associated cancer among women In the U.S. (in the year 2011) 12,000+ new cases 4,000 attributable deaths There are complications related to current methods of cervical cancer prevention – so it’s better to prevent the infection! 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 considerable impact on the mothers and infants concerned and on the cost of neonatal intensive care FAQ 2 (male): Is HPV important? My son won’t get cervical cancer so why bother with this? # of new HPV–associated cancers by sex, in U.S, 2009 Jemal A et al. J Natl Cancer Inst 2013;105:175-201 # of new HPV–associated cancers by sex, in U.S, 2009 Chaturvedi, 2011, J Clin Oncol- data from SEER Jemal A et al. J Natl Cancer Inst 2013;105:175-201 # of new HPV–associated cancers by sex, in U.S, 2009 http://oralcancerfoundation.org/hpv/pdf/JNC-J-Natl-Cancer-Inst-2013-Jemal-175-201.pdf Rates of HPV-associated cancers are rising. Oral cancer rates increased from 2000 to 2009 4.9% 3.9% 1% for Native American men for white men for Asian men If trends continue, the annual number of HPV-positive oropharyngeal cancers is expected to surpass the annual number of cervical cancers by the year 2020. Anal cancer rates doubled from 1975 to 2009 Penile cancer rates increased among Asian men Try saying: HPV vaccine is very important because it prevents cancer. I want your child to be protected from cancer. That’s why I’m recommending that your daughter/son receive the first dose of the HPV vaccine series today. Or try saying: HPV can cause many kinds of cancers – cancer of the mouth, throat, and anus in both women and men as well as the genitals [cervix, vagina, and vulva in women, penis in men]. Each year, about 26,000 people in the U.S. face a diagnosis of one of these cancers—and most could be prevented with HPV vaccine. There are also many more precancerous conditions requiring treatment that can have lasting effects. FAQ 3: Isn’t the HPV vaccine too new to know if it works? HPV Vaccine Impact a. NHANES - HPV Prevalence Studies National Health and Nutrition Examination Survey (NHANES) Compares HPV prevalence before the start of the HPV vaccination program with first 4 years after vaccine introduction Results: In 14-19 yr olds, vaccine-type HPV prevalence decreased 56% (11.5% in 2003-2006 to 5.1% in 2007-2010) Other age groups did not show a statistically significant difference over time Vaccine effectiveness for prevention of infection was an estimated 82% Cummings T, Zimet GD, Brown D, et al. Reduction of HPV infections through vaccination among at-risk urban adolescents. Vaccine. 2012; 30:5496-5499. HPV Vaccine Impact b. Clinic-based Study Women aged 13-26 years who had sexual contact were recruited from 2 primary care clinics in 2006–2007 (0% vaccinated) & 2009–2010 (59% vaccinated) Prevalence for vaccine-type HPV decreased among vaccinated (31.8%–9.9%) & unvaccinated (30.2%–15.4%) subjects, Nonvaccine-type HPV increased (60.7%–75.9%, P < .0001) for vaccinated postsurveillance subjects Kahn JA, Brown DR, Ding L, et al. Vaccine-Type Human Papillomavirus and Evidence of Herd Protection After Vaccine Introduction. Pediatrics. 2012; 130:249-56. HPV Vaccine Impact c. Genital Warts (GW) Studies DENMARK: Population-based registries were used to identify all girls in the birth cohorts 1989-1999 in Denmark, and info about HPV vaccination was obtained for the period 2006-2012. The cohort was linked to incident cases of genital warts. Results: A total of 248,403 girls were vaccinated. There was a highly significant reduction in the occurrence of GW among vaccinated girls. Implications: This study indicates an early and marked population effect of the national HPV vaccination program in Denmark. AUSTRALIA: High HPV coverage; decreases in incidence of GW among young females & heterosexual males Blomberg M, Dehlendorff C, Munk C, Kjaer SK. Clin Infect Dis. 2013 Oct;57(7):929-34. Donovan B, Franklin N, Guy R, Grulich AE, et al. Lancet Infect Dis. 2011 Jan;11(1):39-44. FAQ 4: Is HPV vaccine safe? Moms in focus groups stated concerns about both short- and long-term vaccine safety as a reason they would not vaccinate their child Respondents were not aware that HPV vaccine was tested in adolescents and adults and were concerned that their child’s fertility could be affected by the vaccine HPV Vaccine Safety 57 million doses of HPV vaccine distributed in US from 2006 – 2013 (many more abroad) The most common adverse events reported were considered mild (e.g., sore arm) For serious adverse events reported, no unusual pattern or clustering that would suggest that the events were caused by the HPV vaccine These findings are similar to the safety reviews of MCV4 and Tdap vaccines 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 http://www.cdc.gov/vaccinesafety/concerns/syncope.html Try saying: This is not a new vaccine and for years HPV vaccine has been shown to be very effective and very safe. HPV vaccine has a similar safety profile to the meningococcal and Tdap vaccines. HPV vaccine has been very carefully studied by scientific experts and it’s safety is continually monitored. Like other shots, side effects can happen, but most are mild and go away quickly, primarily arm pain or redness. HPV vaccine has not been associated with any long-term side effects. FAQ 5: Why give this at 11 or 12 years of age? In audience research with moms: Almost all respondents were unaware of the correct age range the vaccine was recommended Respondents also missed the concept of vaccinating before sexual activity Rationale for HPV vaccination at 1112 years of age Optimal vaccine efficacy is derived if the vaccine series is received before onset of sexual activity. (The vaccine is inactive against previously acquired HPV types.) Antibody responses are highest at ages 9 through 15 years. http://pediatrics.aappublications.org/content/129/3/602.full Rationale for vaccinating early: Protection prior to exposure to HPV 82% 18 to 24 Markowitz MMWR 2007; Holl Henry J Kaiser Found 2003; Mosher Adv Data 2006 Will protection last? Efficacy against infection and cervical lesions from HPV strains 16 & 18 -- shown up to 8.4 years with the bivalent vaccine 5 years with the quadrivalent vaccine Ongoing monitoring is essential so we will know if a booster is needed Romanowski B. Hum Vaccin. 2011 Feb;7(2):161-9. Epub 2011 Feb 1. Long term protection against cervical infection with the human papillomavirus: review of currently available vaccines. Try saying: We're vaccinating today so your child will have the best protection possible long before the start of any kind of sexual activity. We vaccinate people well before they are exposed to an infection, as is the case with measles and the other routinely recommended childhood vaccines. Similarly, we want to vaccinate children long before they are exposed to HPV. FAQ 6: Will my child see this as “permission” to have sex? In focus groups, some parents expressed concern that in getting HPV vaccine for their child, they would be giving their child permission to have sex This was one of the top 4 reasons respondents gave when asked why they would not vaccinate their daughter A few parents expressed that while they wanted their child to “wait to have sex,” they understood that might not be the case Receipt of HPV vaccine does not increase sexual activity or decrease age of sexual debut Kaiser Permanente Center for Health Research 1,398 girls who were 11 or 12 in 2006, 30% of whom were vaccinated, followed through 2010 No difference in markers of sexual activity, including Pregnancies Counseling on contraceptives Testing for, or diagnoses of, sexually transmitted infections Bednarczyk Pediatrics Oct 2012 Try saying: Several research studies have shown that getting the HPV vaccine does not make kids more likely to be sexually active. These studies have also shown that getting the HPV vaccine does not make kids more likely to start having sex a younger age. FAQ 7: Would you give HPV vaccine to your child? Emphasizing your personal belief in the importance of HPV vaccine helps parents feel secure in their decision Some respondents in focus groups stated that they would feel more comfortable knowing that the doctor had vaccinated their own child or was planning to (if the child was <11) Respondents in an online survey stated that knowing that oncologists supported the recommendation made them more likely to get their child vaccinated Try saying: I have given HPV vaccine to my son/daughter (or grandchild/niece/nephew/friend's children). I strongly believe in the importance of this cancer-preventing vaccine. Experts, such as the American Academy of Pediatrics, cancer doctors, and the CDC, also agree that getting the HPV vaccine is very important for your child. Learning Objective #3 TIPS ON HAVING YOUR WHOLE OFFICE TEAM FEEL COMFORTABLE COMMUNICATING ABOUT HPV VACCINE 5 Communication Tips 1. Be sure that everyone who has patient 2. 3. 4. 5. contact gets educated on HPV vaccination. Be sure that each office staff group knows their role in immunization communication. Encourage questions; interpret them as natural caution, not refusal. Remember to arrange for the next dose. Remember to give the VIS with each dose. Wrap Up Summary and more resources Summary: Key Points Tell parents that almost everyone gets HPV and HPV can cause a variety of cancers in women and men Remind parents that HPV vaccine is for cancer prevention Provide a strong recommendation for HPV vaccine when patients are 11 or 12 years old Listen carefully to and welcome patient and parent questions especially about safety http://www.cdc.gov/vaccines/who/teens/for-hcp-tipsheet-hpv.html For more information visit: • cdc.gov/vaccines/teens • www2.aap.org/immunization/illnesses/hpv/hpv. html • www.immunize.org/hpv/ • www.chop.edu/service/vaccine-educationcenter/a-look-at-each-vaccine/hpv-vaccine.html Email questions or comments to CDC Vaccines for Preteens and Teens: [email protected] The End Thank you for watching!