HPV Vaccine, We Can Do Better!

HPV Vaccine, We Can do Better!

Paul M. Darden, MD Chief, General & Community Pediatrics Email: [email protected] Office Phone: 405 271-4407

South Carolina Chapter of the American Academy of Pediatrics Annual Meeting, Ashville, NC August 6, 2021 HPV Vaccine, Delivery and Communication

University of Kansas School of Medicine-Wichita Department of Pediatrics Grand Rounds April 10, 2019 revised 9/17/2020

Paul M. Darden, MD Chief, General and Community Pediatrics Disclosure Statement

Paul Darden, MD I have no relevant financial relationships or affiliations with commercial interests to disclose. Thanks to ◦ Peter Szilagyi ◦ Sharon Humiston ◦ CDC HPV speakers bureau

National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention. Grant No. H23IP000950. National Immunization Partnership with the APA (NIPA). You are the Key to HPV Cancer Prevention Pediatric Grand Rounds, July 16, 2014 Sponsored by the American Academy of Pediatrics Professional Practice Gap Healthy People 2020, IID-11.4 and 11D-11.5 ◦ % of male and female adolescents 13-15 years who receive 2 or 3 doses of HPV vaccine ◦ Goal 80% for both 2019 NIS Teen shows that 13-17 years HPV vaccine UTD ◦ US 54.2% ◦ Oklahoma 41.8%

Rhode Island 78.9% - Highest Mississippi 30.5% - Lowest

Elam-Evans LD, Yankey D, Singleton JA, et al. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years - United States, 2019. Mmwr. 2020;69(33):1109-1116. PMID 32817598 Learning objectives 1. Explain the importance of HPV vaccination and current vaccination rates. 2. Examine the current evidence for provider recommendation to increase HPV vaccination rates. 3. Evaluate and apply the current evidence to my HPV vaccination practices October 5, 2018 Approval by the FDA versus Recommendations by the ACIP ACIP shared decision making August 2019 https://www.cnn.com/2018/10/05/health/gardasil-hpv-vaccine-approved-older-ages-bn/index.html

Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices. Mmwr. 2019;68(32):698-702. ACIP recommended shared clinical decision-making regarding potential HPV vaccination for these persons.

MMWR August 16, 2019 https://www.researchamerica.org/polls-and-publications/polls/public-opinion-polls https://www.researchamerica.org/polls-and-publications/polls/public-opinion-polls • Tribeca Film Festival scheduled and then withdrawn • Shown across the nation • Witchita 6/2016, Kansas City 8/2017 • Currently available on Amazon, Vudu, iTunes and Google Play • “Vaxxed Bus” in Oklahoma 10/2017,

Vaccine hesitancy … A new problem?

“The Cow Pock – or – the Wonderful Effects of the New Inoculation!” J. Gillray, 1802 “The impact of vaccination on the health of the world’s people would be hard to exaggerate. With the exception of safe water, no other modality, not even antibiotics, has had such a major effect on mortality reduction and population growth.”

2013 Plotkin, Orenstein, Offit Vaccines And now a vaccine that prevents CANCER!

Human Papillomavirus (HPV) Vaccine

HPV Infection

Most females and males will be infected with at least one type of mucosal HPV at some point in their lives Estimated 79 million Americans currently infected 14 million new infections/year in the US HPV infection is most common in people in their teens and early 20s Most people will never know that they have been infected

Satterwhite et al. Sex Transm Dis. 2013 Number of New HPV-Associated Cancer Cases Each Year

Centers for Disease Control and Prevention. Cancers Associated with Human Papillomavirus, United States—2013–2017. USCS Data Brief No 18. 2020. https://www.cdc.gov/cancer/uscs/pdf/USCS-DataBrief-No18-September2020-h.pdf. Published September 2020. Accessed September 17, 2020. Good News HPV Vaccine Type Prevalence Among Females, NHANES Early vaccine era compared to pre-vaccine era

Markowitz et al. JID 2013;208:385-393 HPV Vaccine Type Prevalence Among Females, NHANES Later vaccine era compared to pre-vaccine era

Oliver et al. JID. 2017:216(5);594-603 2019 Immunization Schedule

www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

Age at 1st dose of HPV vaccine • Before 15th Bday: 2 doses • On or after 15th Bday: 3 doses 2020 Immunization Schedule

https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

Age at 1st dose of HPV vaccine • Before 15th Bday: 2 doses • On or after 15th Bday: 3 doses ACIP June 2019: HPV Vaccine Recommendations

Current Pending  Immunocompromising  Approved not published conditions – 3 doses  Males recommendation  Females – 11-26 routine same as females  Males – 11-21 routine, to  11-26 routine 26 clinical decision-making  Catch-up for all up to age  Can start as early as 9 years 26  Clinical decision – 27-45 HPV vaccine other issues 9-14 years – 2 doses 15 and over – 3 doses History of sexual abuse – 9 years, routine Insurance Vaccines for children covers eligible children through age 18 Affordable Care Act mandates first dollar coverage for vaccines 4 valent versus 9 valent vaccine (current) Either “count”, no recommendation for additional doses

How are we doing? Estimated vaccination coverage, 13-17 years, NIS-Teen, 2006-2019 2019 90% 87%

72%

54% Tdap, 3/2006

HPV vaccine

MenACWY, 5/2005

HPV female, 3/2007 HPV male, 5/2010 Elam-Evans LD, Yankey D, Singleton JA, et al. National, Regional, State, and Selected Local Area Vaccination Coverage Among 2019 - 57% 2019 - 52% Adolescents Aged 13-17 Years - United States, 2019. Mmwr. 2020;69(33):1109-1116. Santoli JM, Lindley MC, DeSilva MB, et al. Effects of the COVID-19 Pandemic on Routine Pediatric Vaccine Ordering and Administration — United States, 2020. MMWR - Morbidity & Mortality Weekly Report. 2020. Adolescent vaccination rates - Oklahoma & US, 2019 *P<.05 2018 to 2019

100% 89%* 90% 88% 90% 77% 80% 72%* 70% 66% 60% 54%* 50% 42% 40% 30% 20% 10% 0% MenACWY Tdap HPV vac ≥ 1 dose HPV vac UTD US Oklahoma

Non-MSA – MSA Central City** -5.1* -0.5 100% 90% 89% 89% 91% 90% -9.6* 90% 84% 80% 71% 74% -9.8* *P<.05 70% 64% 57% 60% 53% 50% 47% 40% 30% 20% 10% 0% MenACWY Tdap HPV vac ≥ 1 dose HPV vac UTD Non-MSA MSA nonprincipal MSA principal City **HPV vaccine, MenACWY diff remain after controlling for poverty

Exemptions: Personal, religious and medical

Oklahoma State Immunization Information System (OSIIS) - State-wide immunization registry (2018, 74.3% adolescent participation) - No direct communication with EMRs - New registry software Fall 2020

2019 HPV vaccine ≥ 1 Tdap ≥ 1 MenACWY ≥ 1 dose UTD Oklahoma 88.0% 77.3% 65.6% 41.8% US 90.2% 88.9% 71.5% 54.2%

The asterisk (*) indicates states demonstrating an upward trend of kindergarteners with NMEs. NME, nonmedical exemption. Olive JK, Hotez PJ, Damania A, Nolan MS. The state of the antivaccine movement in the United States: A focused examination of nonmedical exemptions in states and counties. PLoS medicine. 2018;15(6):e1002578. Oklahoma: Kindergarten School Immunization Rates 2019-2020

https://osdh.maps.arcgis.com/apps/View/index.html?appid=01fc983c1890461d9866fb8a7a75bcfb Shared decision-making for children

Definition: “both parties share information…take steps to build consensus about the preferred treatment, and [reach an agreement] on the treatment to implement”

Issues Examples • Parent making decisions for a child • Breast-feeding • Medically acceptable alternatives • Supine sleep position • For vaccines, public health issues • Car seat use

Opel DJ. A Push for Progress With Shared Decision-making in Pediatrics. Pediatrics. 2017;139(2). http://www.immunize.org/letter/recommend_hpv_vaccination.pdf Accessed 12/14/2016 What is a strong recommendation? ◦ Many studies with consistent results across age groups and vaccines ◦ Provider recommendation, strongest or one of the strongest, associations with vaccination ◦ Almost all studies are cross-sectional, parent or patient report of recommendation ◦ Brewer, et al, 2011 based on surveys 2007 and 2008 ◦ Parents who reported a provider recommendation at baseline were more likely to have received HPV vaccine at follow-up – 51% (46/94) versus 21% (103/473)

Darden PM, Jacobson RM. Impact of a physician recommendation. Human vaccines & immunotherapeutics. 2014;10(9). Parent-reported provider recommendation for adolescent vaccines by year (female) 80 69 70 65 59 60 57 55 57 52 54 49 51 51 50 48 42 39 40 40 37

Percent 40 32 30 20 10 0 2008 2009 2010 2011 2012 2013 MenACWY Tdap HPV vaccine

NIS Teen 2008-2013 UTD forUp those-to-dates with Rates and amongwithout females provider by vaccinerecommendation by vaccine with and without a recommendation

NIS-Teen 2008-2012 State – OK and SC Practices – 9 Parents Parents – 281

Discussion, Recommendation and Receipt 100% 92% 90% 85% 85% 77% 80% 80% 72% 68% 70% 59% 62% 60% 50% 40% 30% 20% 10% 0% Discussion Recommendation Receipt MenACWY Tdap HPV vaccine State – OK and SC Practices – 9 Parents Parents – 281

Recommendation and receipt of vaccine 100% 92% 95% 90% 80% 69% 70% 60% 57% 50% 40% 26% 30% 21% 20% 10% 0% MenACWY Tdap HPV vaccine No Recommendation Recommendation Recommendation versus No recommendation P<.05 all vaccines What is a strong recommendation? ◦ Cross-section of participants in large US managed care plan ◦ 19-26 year old women in 2008 ◦ Case-Control design, HPV vaccine recipients (345) and non-recipients (185) ◦ Differential response rate (25% versus 13%)

Rosenthal SL, Weiss TW, Zimet GD, Ma L, Good MB, Vichnin MD. Predictors of HPV vaccine uptake among women aged 19-26: importance of a physician's recommendation. Vaccine. 2011;29(5):890-895. Summary of Strong Provider Recommendation ◦ Consistent evidence across multiple settings, age-groups and vaccines that patient/parent-reported provider/clinician/doctor recommendation for vaccines is effective in promoting receipt of that vaccine. ◦ There are a few studies that indicate that the patient-reported strength of the doctor’s recommendation is important in promoting receipt of HPV vaccine

Strong Provider Recommendation – What do I say? That’s why I’m recommending that your daughter/son receive the first dose of HPV vaccine today.

Document undated, accessed 2014 Your child is due for vaccinations today to help protect against meningitis, HPV cancers, and pertussis. We'll give those shots at the end of the visit.

April 2016 Now that your son is 11, he is due for vaccinations today to help protect him from meningitis, HPV cancers, and pertussis.

December 2016 – Tips and Timesavers https://www.cdc.gov/hpv/hcp/for-hcp-tipsheet-hpv.pdf State – OK and SC Practices – 11 Office staff – 71 Providers* Providers – 162 Parents – 281

How often do you use a strong recommendation … >90% 100% HPV vac vs Tdap, MenACWY 90% 89% 90% P<..05 80% 74% 70% 60% 50% 40% 30% 20% 10% 0% MenACWY Tdap HPV vaccine

*Nurses and clinicians Which of these is the strongest recommendation? 1. The AAP/CDC recommends HPV vaccine (passive) 2. I recommend that your child receive HPV vaccine (directive) 3. The nurse will be in to give you HPV Vaccine (expectant) 4. What do think about getting HPV vaccine? (collaborative) https://www.health.state.mn.us/people/immunize/hcp/hpvvideos.html https://www.youtube.com/watch?time_continue=8&v=vFHjK5L0t- Y&feature=emb_logo Accessed 9/18/2020 Two Silly Examples MMR vaccine and diseases: Randomized trial of communication Respondents: National random sample (Knowledge Networks) of parents with a child < 18 surveyed in 2 waves, N=1,759. 1. Health and vaccine attitudes 2. Randomly assigned to intervention

Interventions, first 3 used text from CDC material 1. “Autism correction”, lack of a link of MMR and Autism 2. “Disease risks”, text about symptoms and adverse events of MMR 3. “Disease narrative”, narrative about an infant hospitalized with measles 4. “Disease images”, images of diseases prevented by MMR 5. “Control”, text about costs and benefits of bird feeding Outcome: Vaccination knowledge (“vaccines cause autism”) and intent questions (“MMR for next child”). MMR vaccine and diseases: Randomized trial of communication

Results #1 correct knowledge but intent to vaccinate #3 and 4 correct knowledge Summary of communication trials Currently recommended education/communication ➢ Can improve knowledge particularly among those with no concerns about vaccination ➢ May decrease the intent to vaccinate among those with concerns about vaccination even while improving knowledge A randomized trial of communication training: The intervention

Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics. 2016. A randomized trial of communication training: HPV vaccine outcomes in 11-12 y/o

3 months 6 months Pre % Post % Difference Post % Difference ≥ 1 dose Control 30.0 37.3 6.4 41.2 9.5 Announce 25.5* 38.0 11.5* 42.0 14.9* Convers 21.3* 30.3 8.4 33.7 11.5 3 doses Control 8.8 11.5 1.9 13.5 3.6 Announce 6.4* 9.2 2.6 10.7 3.9 Convers 5.6* 7.2 1.5 9.2 3.3

* P<.05 comparison to control

Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics. 2016. MCHB Adolescent Decision Making Project Study Overview State – OK and SC Practices – 9 Office staff – 71 Importance of vaccine Providers – 162 Parents – 281 … how important does THE OFFICE feel these vaccines are to the health of preteens and teens? % Very Important 100% 94% 94% 90% 83% 83% 83% 86% 78% 78% 80% 76% 70% 60% 50% 40% 30% 20% 10% 0% Parents Office staff Providers* MenACWY Tdap HPV vaccine

*Nurses and clinicians State – OK and SC Practices – 11 Office staff – 71 Office staff Providers – 162 Parents – 281

Do parents express concerns to you regarding any of the following vaccines 70%

60% 58%

50%

40%

30% 27% 22% 20% 16%

10% 4% 6% 0% Prior to the visit After the visit MenACWY Tdap HPV vaccine What type of recommendation works?

1-19 month old patients, oversampled vaccine hesitant

◼ “Well, we have to do some shots”

◼ Presumptive

◼ “What do you want to do about shots?”

◼ Participatory

Participatory v. presumptive aOR for resistance: Opel DJ, Heritage J, Taylor JA, et al. 17.5 (1.2–253.5) Pediatrics. Dec 2013;132(6):1037-1046. Summary ▪ Involve the whole office, including the front office and nursing personnel ▪ Initiate the vaccine discussion with a recommendation for receipt ▪ Discuss all of the vaccines due together, do not separate out any vaccine especially HPV vaccine ▪ Avoid using directive or passive language and use either expectant or invitational ▪ Today you will receive meningococcal, HPV and tetanus vaccine … ▪ Today would you like to receive … YOUR OFFICE SYSTEMS CAN BOLSTER SERIES COMPLETION Provider Prompts: QI

13 CORNET (Residency site) Practices

Monthly learning collaborative calls with QI experts

Monthly data collection (10 charts/month/practice)

Focus on integrating resident QI, strong recommendations, consistency in practice change Proportion of Eligible Teens

1 Receiving HPV Vaccinations 0.9

0.8 0.79 0.7 0.6 0.62

0.5 0.46 0.4 13 % 0.3 Point 0.2 increase!! 0.1 Start of Intervention 0 J F M A M J J A S O N D J F M A M J J A S 2013 2014 Get your whole team involved 1. Be sure that everyone who has patient contact gets educated on HPV vaccination.

2. Be sure that each office staff group knows their role in HPV immunization and what they should say.

3. Have everyone encourage questions; interpret as natural caution, not refusal.

4. Systematically arrange for the next dose (schedule before patient leaves) Standing Orders Standing orders can be effective We found impact in some (not all) practices as a QI program

Not always easy to implement in practices Require some sort of prompt (or nurse look-up) Require buy-in by BOTH physicians and nurses The benefits of being part of an Academic Pediatric Association HPV QI Learning Collaborative…

• Increase your HPV vaccination rates and decrease your office missed opportunity rates • Learn from experts and peers • Get MOC credit in a meaningful way!

Continuity Clinic sites contact Holly Tyrrell: [email protected] Community practices contact Jen Le: [email protected] The next QI Learning Collaborative is starting in Fall-Winter of 2018 HPV VACCINATION RESOURCES

For More Information • Shot by Shot http://shotbyshot.org/story-gallery • AAP Info for parents (healthychildren.org) Info for clinicians (http://www2.aap.org/ immunization/illnesses/hpv/hpv.html) • Immunization Action Coalition http://www.immunize.org/ • CHOP Vaccine Education Center http://vec.chop.edu/ • EZ IZ http://eziz.org/ • CDC HPV-9 Resource

http://www.cdc.gov/vaccines/who/teens/downloads/9vHPV-guidance.pdf

HPV Vaccine Resources in Spanish

Patients Resources for Resources cdc.gov/vaccines/who/teens/for-hcp/hpv-resources.html For more information, including free resources for yourself and your patients/clients, visit: cdc.gov/vaccines/YouAreTheKey

Email questions or comments to CDC Vaccines for Preteens and Teens: [email protected] Summary 1. HPV vaccination is important for cancer prevention but current vaccination rates are low 2. Start vaccinating at ages 11-12; including males 3. Recommend HPV vaccine strongly, normalize it, involve the whole office 4. Plan to increase your office HPV vaccination rates!

 Reduce missed opportunities by using:

 Nurse/EMR prompts, standing orders and QI

 Try to use reminder-recall 5. Use some great HPV vaccination resources Acknowledgement

National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC-RFA-IP14-1405PPHF14). Grant No. H23IP000950. National Immunization Partnership with the APA (NIPA). Academic Pediatric Association (recipient organization). PG Szilagyi (UCLA) and C Rand (University of Rochester), Co-Principal Investigators.

96 “The Cow Pock – or – the Wonderful Effects of the New Inoculation!” J. Gillray, 1802