Tag Archives: HPV vaccine

Influence of education strategies on young women’s knowledge and attitudes about the HPV vaccine

Lack of knowledge about human papilloma virus (HPV) has been cited as a barrier vaccination uptake. This study examines the effectiveness of two types of education on women’s intentions to become vaccinated against HPV.

The incidence of cervical cancer, a preventable disease, in the United States was 6.7 per 100,000 women in 2011, with a mortality rate of 2.3 per 100,000.1 Nearly all cervical cancers (99.7%) are caused by the human papillomavirus (HPV).Vaccination against HPV can prevent 90% of cervical cancers, but only 20% of U.S. women aged 19-26 years have received at least one dose of the vaccine.3 The author conducted a study to assess the usefulness of two educational interventions in increasing women’s knowledge about HPV and the Pap test, with the ultimate hope that this greater knowledge would translate into increased HPV vaccine uptake.

A systematic search of the health science databases Academic Search Premier, Women’s Health International, CINAHL, Medline, and PubMed was performed using the key words HPV, knowledge, beliefs, behaviors, education, prevention, and intervention to identify current research on educational intervention studies to promote HPV vaccination. Almost 5,000 articles were found. The search was then narrowed to English-language, scholarly, peer-reviewed studies with interventions aimed at females aged 13-64 years and published since 1999. After the limits were applied, 74 studies met inclusion criteria and were synthesized to draw conclusions about HPV knowledge and beliefs, women’s educational needs, and the types of educational interventions found effective at increasing HPV vaccine uptake among women.

A review of educational intervention studies suggested that lack of knowledge about HPV is a common barrier to HPV vaccine uptake.4-7 HPV knowledge tended to increase post-intervention. However, the studies all used only one educational approach to increase HPV knowledge. Most used written information alone; a few used oral presentations or videos. Some authors suggested that written material alone might not be as effective as verbal or video messages.8,9 To ascertain the usefulness of adding video messaging, the author compared the effectiveness of video plus written information with written information alone at increasing women’s HPV knowledge, Pap test knowledge, and vaccine intentions. Implications are drawn for future patient education strategies and healthcare provider (HCP) practice.

Method

Following acquisition of Internal Review Board approval, a quasi-experimental pre-test/post-test design was used. Participants were recruited from rural women’s healthcare clinics and via university email and Facebook. The prospective sample included 194 women aged 18-26 years who had not yet had the HPV vaccine. Women were excluded if they did not meet age criteria, were non-English speaking, were pregnant, or had received any HPV vaccinations. Participants were assigned to one of two educational interventions: (1) a written HPV factsheet created by the CDC (Group 1) or (2) a video containing HPV information and a cervical cancer survivor story plus the written HPV factsheet (Group 2).*

All participants gave written informed consent prior to completing the pre-test. Post-tests were administered 2 months after enrollment. A 2-month follow-up was chosen to allow time for participants to access the HPV vaccine series post-intervention, and to assess long-term HPV knowledge retention as a result of the educational intervention. Vaccine status was verified for all but 12 participants (6%) using a 3-step approach: chart audit, 42%; state immunization database, 39%; and self-report, 13%. Four participants in Group 1 and four in Group 2 received the HPV vaccine during the study period. Therefore, vaccine intention, rather than vaccine uptake, was evaluated as the study outcome variable. Intention to accept the HPV vaccine was determined based on a yes/no response to the question, “If cost were not an issue, would you accept the HPV vaccine for yourself?”

The instrument chosen for this study was used with permission from its designer, who confirmed its validity and reliability.10 The instrument is based on health belief model (HBM) constructs. Modifications of specific HBM constructs were made for this study; additional psychometrics are displayed in Table 1 and Table 2. Items assessing health beliefs were scored on a 4-point Likert scale, wherein 1 = strongly disagree and 4 = strongly agree. Other items on the instrument included history and demographic information to assess each participant’s sexual history, race, age, relationship status, and education level. In addition, 5 items assessed vaccine acceptability (e.g., Would you get a vaccine to prevent HPV infection?), 12 items assessed HPV knowledge, and 6 items assessed Pap test knowledge.

Results

Mean age of the 194 participants was 22 years. Most were white (n = 174); the remainder were black (n = 5), Hispanic/Latina (n = 4), Asian (n = 6), Native American (n = 1), or mixed (n = 4). Ninety-one participants were single, 84 were married and/or living with a partner, and 19 were in a relationship but not living with a partner. Ninety-one participants had attended some college, 45 had a high school diploma or GED, 36 had a bachelor’s degree, and 12 reported a graduate or professional degree.

Risk factors for HPV

Most participants had several risk factors for contracting HPV infection, including early age of sexual debut (mean age, 17 years), having >1 lifetime sexual partner (mean number of partners, 5), and not using condoms with their last act of sexual intercourse (proportion, 57%). In addition, 29 women older than 21 years reported never having had a Pap test. Among women who had undergone a Pap test, 38 had an abnormal result, with 19 knowing that the abnormality was a result of an HPV diagnosis, placing them at risk for developing cervical cancer.

HPV vaccine attitudes and perceived barriers

Reported barriers to getting the vaccine included cost, perceived risk, lack of availability, and lack of need for it. Figure 1 shows the percentage of participants who perceived these barriers before and after the educational intervention. The groups did not differ significantly in this regard, so the findings are reported as the total sample.

HPV vaccine intentions

Before and after receiving the HPV educational intervention, participants were asked about their willingness to accept the HPV vaccine for themselves and, if they became parents, for their adolescent children. This willingness increased significantly in both Group 1 and Group 2, with no difference between groups in terms of their willingness to accept the vaccine for themselves or their adolescent daughters. However, after the educational intervention, participants in Group 2 were significantly more likely than those in Group 1 to say they would accept the vaccine for their adolescent sons (Figure 2).

Knowledge scores

Participants were assessed on HPV and Pap test knowledge at baseline and at study completion. The groups did not differ on knowledge scores at pre-test or posttest, and both showed significant knowledge gains as a result of receiving education. This latter finding suggests that the two educational approaches (i.e., the factsheet alone vs. the video plus factsheet) did not differ in their effectiveness (Table 3 and Table 4).

Discussion

Impact on knowledge

The author hypothesized that the combination of a factsheet and a video-based first-person account story of a woman diagnosed with cervical cancer, with clear messages about prevention and treatment, would be a more powerful educational tool for increasing participants’ HPV and Pap test knowledge than a written factsheet alone. It turned out that knowledge increased significantly in both groups, and that the difference in knowledge gains between groups was not significant. This finding was similar to that of Krawczyk et al,11 who compared the efficacy of two HPV educational interventions, a pamphlet versus a video, in increasing HPV knowledge and vaccination intentions in college students. The investigators found that both educational interventions were similarly effective in this regard.11 The current study used a video that incorporated music, images, and cultural brokerage through a first-person account of a cervical cancer survivor. Although the difference between groups was not significant, Group 2 did have slightly higher knowledge scores than Group 1. It is unclear whether this slight edge was a result of the video messaging itself or the receipt of two educational strategies that reinforced each other.

At enrollment, participants’ HPV and Pap test knowledge levels were low, even among those who had regular contact with HCPs for Pap testing. This finding is consistent with the literature.12-16 Persistence of knowledge deficits despite increasing access to HCPs through the Affordable Care Act (ACA) speaks to unmet educational needs. Reasons for any woman’s knowledge deficits with regard to HPV and Pap testing, despite regular contact with an HCP, are unclear but may reflect a lack of time in the office for face-to-face education or an HCP’s lack of skill in imparting such information to a patient.17 In this study, 29 participants aged 21 or older reported never having had a Pap test. Lack of knowledge has been cited as a barrier to disease prevention-seeking behaviors such as getting a Pap test.18,19 Studies have shown that many women do not understand the purpose of a Pap test.20-22

Impact on HPV vaccination intentions

In this study, after the intervention,  both groups were similarly and significantly more willing to accept the HPV vaccine for themselves and their adolescent children; Group 2 was significantly more willing than Group 1 to accept the vaccine for their adolescent sons. Evaluation of content in the two educational tools showed that the video may have been more gender neutral than the factsheet with regard to eligibility criteria for HPV vaccination. The video simply mentioned the ages for which the vaccine has FDA approval—“All males and females 9-26 years of age can receive the HPV vaccine”—whereas the factsheet was more specific about different age and risk groups who should be vaccinated.23 

Although vaccination intentions increased, vaccine uptake during the study was not significantly affected; only 8 participants, 4 in each group, became vaccinated. Several barriers to vaccination might have influenced this finding. A major barrier was cost. Even though 84% of the participants reported having insurance coverage, nearly 41% of respondents on the pre-test and 34% of respondents on the post-test cited cost as a barrier to getting vaccinated. Although more young people are being insured through the ACA, there may be gaps in insurance coverage or lack of knowledge regarding vaccine coverage among the newly insured. Another barrier was access; many private HCP offices did not stock the vaccine. A third barrier may have been respondents’ lack of perceived need for the HPV vaccine. Some felt monogamy with a male partner or having a lesbian orientation eliminated the need. Others were at the end of the age bracket for HPV vaccination and did not seek to begin the vaccine series. A few reported prior diagnosis with HPV as a reason for not getting vaccinated. Finally, some participants had an inherent fear of all vaccines.

Limitations

Most study participants were white—the sample had little ethnic or racial diversity—and resided in rural Appalachia. Inferences about women from other ethnicities, races, or geographic locations cannot be made. Self-selection may indicate some bias by participants toward the topic, which would make their responses less representative of the population as a whole. Strict inclusion criteria for non-vaccinated participants prevented some age-eligible women from participating. Less stringent inclusion criteria might have provided interesting comparisons between vaccine-naïve and experienced participants. Finally, few participants became vaccinated during the study; therefore, conclusions can be drawn only regarding the impact HPV education had on intentions toward HPV vaccination.

Clinical implications

Nurse practitioners (NPs) are many patients’ first point of contact for healthcare information. NPs need to recognize that knowledge deficits regarding HPV and Pap testing exist, even among patients who visit regularly for Pap testing. NPs can aim to fill these gaps during every patient encounter. A simple factsheet can help fill the gap, but if NPs can provide educational videos to supplement the factsheet, patients may be even more motivated to get the HPV vaccine. NPs also need to remember that even if a given patient is older than 26, if she learns about the ability of the HPV vaccine to prevent cervical cancer, she will likely know that she should get her own children—including sons as well as daughters—vaccinated when they reach their preteen years. HPV vaccination is recommended by the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American Academy of Pediatrics, the CDC, and the Immunization Action Coalition.24 In addition to using educational tools to increase women’s knowledge about HPV and Pap testing, NPs can aim to overcome barriers to patients receiving the HPV vaccine by:

• helping insured patients understand that vaccines are covered by most insurance plans;

• helping uninsured patients by locating low- or no-cost vaccine options through state Vaccines for Children programs and pharmaceutical discount programs;

and

• dispelling fears and vaccine myths by distributing factsheets in their offices or clinics.

NPs can also try to disseminate information in places commonly viewed by the general public. This approach is important for women who do not undergo regular checkups. NPs need to try to reach these women where they live, work, shop, or travel to provide health information on the necessity of Pap testing and HPV vaccination.

More research on theoretically grounded educational interventions among differing populations at risk for HPV is needed. In particular, more research is needed to determine why women who have regular contact with HCPs lack knowledge about HPV and the HPV vaccine. In addition, more research is needed regarding gender bias in HPV vaccine recommendations. This study indicates a significant increase in women’s willingness to vaccinate adolescent sons following the video-based educational program. It is unclear whether the more gender-neutral video messaging was the cause of the discrepancy. Replication of this study among parents of adolescent children would help enhance NPs’ knowledge about adaptations that might be needed with regard to future HPV educational literature.

Crystal G. Sheaves is a Senior Lecturer at West Virginia University School of Nursing in Charleston. Financial support for this article was provided by West Virginia Immunization Network, a program of The Center for Rural Health Development, Inc.; and Sigma Theta Tau, Alpha Rho Chapter. The author states that she became a speaker for Merck & Co. after the study was conducted, and that Merck played no role in the funding of this study.

Acknowledgments

The author thanks Shalanda Bynum, PhD; Ilana Chertok, PhD; Stacey Culp, PhD; Marilyn Smith, PhD; Barbara Nunely, PhD; and Janie Leary, PhD, for their scientific guidance on the study.

References

1. Cervical Cancer Screening and Prevention. Practice Bulletin No. 157. Obstet Gynecol. 2016;127(1):e1-e20.

2. Ault KA. Epidemiology and natural history of human papillomavirus infections in the female genital tract. Infect Dis Obstet Gynecol. 2006;2006 suppl:40470.

3. CDC. Adult vaccination coverage – United States, 2010. MMWR Morbid Mortal Wkly Rep. 2012;61(4):66-72.

4. Mills LA, Vanderpool RC, Crosby RA. Sexually related behaviors as predictors of HPV vaccination among young rural women. J Womens Health (Larchmt). 2011;20(12):1909-1915.

5. Juraskova I, Bari RA, Obrien MT, McCaffery KJ. HPV vaccine promotion: does referring to both cervical cancer and genital warts affect intended and actual vaccination behavior? Womens Health Issues2011;21(1):71-79.

6. Mock J, McPhee SJ, Nguyen T, et al. Effective lay health worker outreach and media-based education for promoting cervical cancer screening among Vietnamese American women. Am J Public Health. 2007;97(9):1693-1700.

7. Patel DA, Zochowski M, Peterman S, et al. Human papillomavirus vaccine intent and uptake among female college students. J Am Coll Health. 2012;60(2):151-161.

8. Rosen NO, Knäuper B, Dio P, et al. The impact of intolerance of uncertainty on anxiety after receiving an informational intervention about HPV: a randomized controlled study. Psychol Health. 2010;25(6):651-668.

9. Waller J, Marlow LA, Wardle J. The association between knowledge of HPV and feelings of stigma, shame, and anxiety. Sex Transm Infect. 2007;83(2):155-159.

10. Bynum SA, Brandt HM, Friedman DB, et al. Knowledge, beliefs, and behaviors: examining human papilloma-virus-related gender differences among African American college students. Am Coll Health. 2011;59(4):296-302.

11. Krawczyk A, Lau E, Perez S, et al. How to inform: comparing written and video education interventions to increase humanpapilloma virus knowledge and vaccination intentions in young adults. J Am Coll Health. 2012;60(4):316-322.

12. Cermak M, Cottrell R, Murnan J. Women’s knowledge of HPV and their perceptions of physician educational efforts regarding HPV and cervical cancer. Community Health. 2010; 35(3):229-234.

13. Fry AM, Ferries-Rowe EA, Learman LA, Haas DM. Pap smear versus speculum examination: can we teach providers to educate patients? J Womens Health (Larchmt). 2010;19(9): 1715-1719.

14. Kahn JA, Slap GB, Bern stein DI, et al. Psychological, behavioral, and interpersonal impact of human papillomavirus and Pap test results. J Womens Health (Larchmt). 2005;14(7):650- 659.

15. Waller J, Marlow LA, Wardle J. Anticipated shame and worry following an abnormal Pap test result: the impact of information about HPV. Prev Med. 2009;43(5): 415-419.

16. Warren K. HPV knowledge among female college students and the short-term effectiveness of HPV education. Internet J Acad Phys Assist. 2010;7(2).

17. Bayer AM, Nussbaum L, Cabrera L, Paz-Soldan VA. Missed opportunities for health education on Pap smears in Peru. Health Educ Behav. 2011;38(2): 198-209.

18. Bynum S, Brandt HM, Friedman DB, et al. Knowledge, beliefs, and behaviors: Examining human papillomavirus-related gender differences among African American college students. J Am Coll Health. 2011; 59(4):296-302.

19. Juraskova I, O’brien M, Mullan B, et al. HPV vaccination and the effect of information framing on intentions and behavior: an application of the theory of planned behavior and moral norms. Int J Behav Med2012;19(4):518-525.

20. Hawkins NA, Cooper CP, Saraiya M, et al. Why the Pap test? Awareness and use of the Pap test among wom en in the United States. J Womens Health (Larchmt)2011;20(4):511-515.

21. Panagopoulou E, Giata O, Montgomery A, et al. Human papillomavirus and cervical screening misconceptions undermine adherence. Am J Health Promot. 2011;26(1):6-9.

22. Vasconcelos CT, Pinheiro AK, Castelo AR, et al. Knowledge, attitudes, and practice related to the Pap smear test among users of a primary health unit. Rev Lat Am Enfermagem. 2011; 19(1):97-105.

23. CDC. Genital HPV Infection – Fact Sheet. Last updated May 19, 2016.

24. Give a strong recommendation for HPV vaccine to increase uptake!

*Note: This video was prepared, and the study was conducted, before the HPV 9-valent vaccine became available.

Boosting HPV vaccination rates: A call to action

Faculty

Nancy R. Berman, MSN, ANP-BC, NCMP, FAANP, is a nurse practitioner at Michigan Healthcare Professionals in Farmington Hills and a Clinical Instructor in the Department of Obstetrics and Gynecology at Wayne State University School of Medicine in Detroit, both in Michigan.

Intended audience

This continuing education (CE) activity has been designed to meet the educational needs of nurse practitioners, certified nurse-midwives, and other advanced practice clinicians who care for women.

CE approval period

Now through May 31, 2017

Estimated time to complete this activity

1 hour

CE approval hours

1.0 contact hour of CE credit, including 1.0 contact hour of pharmacology content

Needs assessment

Most cervical cancers are preventable. The incidence of cancer related to HPV infection has declined significantly since the inauguration of screening programs in the U.S. more than 50 years ago. However, too many women are still developing cervical cancer, and 4,400 are dying of it each year. More cases of cervical cancer could be prevented with increased uptake of HPV vaccination, increased addition of HPV testing in screening, and improved access to cervical cancer screening in under-screened and unscreened populations.

Goal statement

Nurse practitioners and other advanced practice clinicians who care for women will make a strong recommendation that children aged 11 or 12 get fully immunized against HPV so as to prevent HPV-related diseases in the future.

Educational objectives

At the conclusion of this educational activity, participants should be able to:

1. Understand the efficacy, safety, and immunogenicity of the HPV vaccine, including the new 9-valent vaccine.

2. Be familiar with all of the ACIP guidelines for the HPV vaccine.

3. Boost HPV vaccine uptake in their patient population.

Accreditation statement

This activity has been evaluated and approved by the Continuing Education Approval Program of the National Association of Nurse Practitioners in Women’s Health (NPWH), and has been approved for 1.0 contact hour of CE credit, including 1.0 contact hour of pharmacology content.

Faculty disclosures

NPWH policy requires all faculty to disclose any affiliation or relationship with a commercial interest that may cause a potential, real, or apparent conflict of interest with the content of a CE program. NPWH does not imply that the affiliation or relationship will affect the content of the CE program. Disclosure provides participants with information that may be important to their evaluation of an activity. Faculty are also asked to identify any unlabeled/unapproved uses of drugs or devices made in their presentation.

Nancy R. Berman, MSN, ANP-BC, NCMP, FAANP, has disclosed that she has financial relationships with Hologic and Shionogi.

Disclosure of unlabeled use

NPWH policy requires authors to disclose to participants when they are presenting information about unlabeled use of a commercial product or device or an investigational use of a drug or device not yet approved for any use.

Disclaimer

Participating faculty members determine the editorial content of the CE activity; this content does not necessarily represent the views of NPWH or Merck & Co., Inc. This content has undergone a blinded peer review process for validation of clinical content. Although every effort has been made to ensure that the information is accurate, clinicians are responsible for evaluating this information in relation to generally accepted standards in their own communities and integrating the information in this activity with that of established recommendations of other authorities, national guidelines, FDA-approved package inserts, and individual patient characteristics.

Successful completion of this activity

Successful completion of this activity, J-16-02, requires participants to:

1. “Sign In” at the top right-hand corner of the website if you have an NPWH account. You must be signed in to receive credit for this course. If you do not remember your username or password, please follow the “Forgot Password” link and instructions on the sign-in page. If you do not have an account, please click on “Create an Account.”

2.Read the learning objectives, disclosures, and disclaimers on the next page.

3.Check “Agree to Terms” on the next page and then click the “Continue” button.

4. Study the material in the learning activity during the approval period (now through May 31, 2017).

5.Complete the posttest and evaluation. You must earn a score of 70% or better on the posttest to receive CE credit.

6.Print out the CE certificate if successfully completed.

Commercial support

This activity is supported by educational grants from Merck & Co., Inc.

Before reading the article, click here to take the pretest.

Cervical cancer, caused in nearly all cases by human papillomavirus (HPV), is considered a vaccinepreventable disease. Anogenital warts and other forms of cancer can also be caused by HPV, and can be reduced in frequency with HPV vaccination. Despite the proven efficacy and safety of the three available HPV vaccines—one of which targets up to nine different HPV genotypes—only about one-third of girls in the United States have received the three recommended doses. The author reviews information about the HPV vaccines and the guidelines for their use, and offers strategies for healthcare providers to implement in order to improve HPV vaccine uptake in their age-appropriate patients.

Human papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States.Almost all sexually active adults are or will be infected by HPV at some point in their lives, even if they have had sex with only one other person. Although the vast majority of HPV infections are asymptomatic and resolve spontaneously, a few persist and can lead to cancer.2 Persistent infections with oncogenic HPV types can cause cancers of the cervix, vulva, vagina, anus, and penis, as well as the oropharynx. Infection with non-oncogenic HPV types can cause anogenital warts.

About 79 million persons in the U.S. are already infected with HPV, and 14 million persons acquire HPV infection each year.3 An estimated 17,600 women and 9,300 men receive a diagnosis of an HPVrelated cancer each year. For U.S. women, cervical cancer is the most common HPV-related cancer; approximately 11,000 women are diagnosed with it annually and 4,400 women die of it. For U.S. men, oropharyngeal cancer is the most common HPV-related cancer; about 7,200 U.S. men are diagnosed with it each year.

In an Annual Report to the Nation on the Status of Cancer, Jemal et alreported that many types of HPV-related cancers were on the rise, some disproportionately affecting certain racial and ethnic minorities. For example, from 2000 to 2009, oral cancer rates increased 4.9% for Native American men, 3.9% for white men, 1.7% for white women, and 1% for Asian men. Anal cancer rates doubled from 1975 to 2009. Vulvar cancer rates rose for white women and African-American women and penile cancer rates increased among Asian men.

Most cervical cancers are preventable. The incidence of this disease has declined significantly since the inauguration of screening programs in the U.S more than 50 years ago.5 However, too many women are still developing cervical cancer, and 4,400 are dying of it each year. More cases of cervical cancer could be prevented with increased uptake of HPV vaccination, increased addition of HPV testing in screening, and improved access to cervical cancer screening in under-screened and unscreened populations.

HPV vaccines

For decades, the best that healthcare providers (HCPs) could offer patients in terms of lowering their risk for developing HPV-related cancers were screenings for cervical cancer precursors and for anal pre-cancers and cancers (in highrisk populations) and inspection for vulvar pre-cancers and cancers. But in June 2006, the FDA approved the first vaccine to prevent disease caused by any of four HPV genotypes: 6 and 11, which cause anogenital warts; and 16 and 18, which are the most common causes of cervical cancer.6

Three HPV vaccines are on the market in the U.S. (Table).The bivalent HPV (2vHPV), quadrivalent HPV (4vHPV) and 9-valent HPV (9vHPV) vaccines each target HPV 16 and 18, the types that cause about 70% of cervical cancers and most other HPV-linked cancers in women and men.3,7 The 9vHPV vaccine targets five additional cancer-causing types (HPV 31, 33, 45, 52, 58), which account for about 15% of cervical cancers. The 4vHPV and 9vHPV vaccines also protect against HPV 6 and 11, the types that cause 90% of anogenital warts.

Efficacy

Clinical trials have suggested that HPV vaccines, if used optimally, could likely prevent most cervical cancers.2 Of 10,000 young women vaccinated as part of clinical trials before they could have been exposed to oncogenic forms of HPV, none developed HPV 16- or 18-associated cervical lesions, which are precursors to invasive cancer.8,9 HPV vaccines have been shown to prevent other HPV 16- or 18-associated anogenital pre-cancers and HPV 6- or 11-associated genital warts with similar efficacy.9,10 Women who received the 2vHPV vaccine as part of a clinical trial had a much lower prevalence of oral HPV infection than did participants who had not received the HPV vaccine.11

In a study reported in March 2016, Markowitz et al12 analyzed 4vHPV type prevalence (i.e., types 6, 11, 16, and 18) in cervicovaginal specimens from females aged 14- 34 years in NHANES (National Health and Nutrition Education Survey) in the pre-vaccine era (2003-2006) and during 4 years of the vaccine era (2009-2012). Within 6 years of HPV vaccine introduction, there was a 64% decrease in 4vHPV type prevalence among females aged 14-19 and a 34% decrease in 4vHPV type prevalence among those aged 20-24 years. There was no decrease in 4vHPV type prevalence in older age groups.

Because the HPV vaccine has been available for only 10 years, it will take a while to assess its efficacy in preventing invasive cancers that take years or decades to develop following persistent infection.

Safety

Three population-based safety studies of the HPV vaccine have been conducted in the U.S.13-15 These studies have identified no serious safety concerns, although one study showed an increased risk of syncope on the day of vaccination and skin infections in the 2 weeks following vaccination.15 Gee et al12 evaluated the risk for venous thromboembolism (VTE) in persons aged 9-26 years, and found no increased risk of VTE following vaccination with the 4vHPV vaccine. Chao et al14 found no association between 4vHPV vaccine use and 16 autoimmune conditions.

According to ongoing safety monitoring by the CDC, most reports of adverse reactions to the vaccine are non-serious.16 Among the 7.6% of reports classified as serious, the most common side effects are headache, nausea, vomiting, and fever. Syncope is a common non-serious problem in both female and male adolescents who receive the HPV vaccine. Of note, syncope is not specific to the HPV vaccine. It is recommended that after receiving the injection, patients remain seated for 15 minutes before leaving the clinical setting.

Impact

Drolet et al17 conducted a systematic review and meta-analysis of 20 studies in 9 high-income countries to assess population-level consequences and herd effects after female HPV vaccination programs  and to verify whether the high efficacy reported in randomized controlled trials was materializing in real-world situations. The investigators found that in countries with female vaccination coverage >50%, HPV type 16/18 infections decreased significantly, by 68%, and anogenital warts decreased significantly, by 61%, between pre- and post-vaccination periods in girls aged 13-19 years. In addition, significant reductions were recorded in HPV types 31, 33, and 45 in this age group of girls, suggesting cross-protection. Furthermore, the incidence of anogenital warts declined significantly in boys younger than 20 years and in women aged 20-39 years, suggesting herd effects. In countries with female vaccination coverage <50%, significant reductions in HPV types 16/18 infection and in anogenital warts occurred in girls younger than 20, with no indication of cross-protection or herd effects.

Duration of immunity

According to a 2011 review, the HPV vaccine was found to provide protection against persistent cervical HPV 16/18 infections for up to 8 years—the maximum time of research follow-up at that point.18 More will be known about the total duration of protection as research continues. To date, no evidence suggests waning immunity such as that seen with the menin go coccal conjugate vaccine, which now requires a second dose. Multiple cohort studies are in progress to monitor the duration of immunity.

More about the 9-valent vaccine

To gain the recent endorsement of the CDC’s Advisory Committee on Immunization Practices (ACIP), the 9vHPV vaccine had to demonstrate efficacy, immunogenicity, and safety.19 In particular, the newest vaccine had to show efficacy in terms of preventing infection and disease related to HPV 31, 33, 45, 52, and 58 in a susceptible population and of generating an antibody response to HPV 6, 11, 16, and 18 that was non-inferior to that generated by the 4vHPV vaccine. Studies conducted by Joura et al20 and Luxembourg et al21 showed precisely that.

In 7 pre-licensure studies, the 9vHPV vaccine was evaluated in more than 15,000 females and males.22 In some studies, the 9vHPV vaccine was compared with the 4vHPV vaccine. The 9vHPV vaccine caused slightly more reactions— primarily swelling and redness—at the injection site. As with the 4vHPV vaccine, side effects associated with the 9vHPV vaccine were generally mild. A video summarizing information about the 9vHPV vaccine is available here.

ACIP guidelines

Routine immunizations for 11- and 12-year-olds include HPV vaccination. HCPs should recommend the HPV vaccine on the same day and in the same way as the other vaccines for preteens.

Age, gender, and vaccine type

ACIP recommends that routine HPV vaccination be initiated at age 11 or 12, although the vaccination series can be started as early as age 9.19 Vaccination is also recommended for females aged 13-26 and for males aged 13-21 who have not been vaccinated previously or who have not completed the 3-dose series. HPV vaccination is recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) who have not been vaccinated previously or have not completed the 3-dose series. Females should receive the 2vHPV, 4vHPV, or 9vHPV vaccine and males should receive the 4vHPV or 9vHPV vaccine. The dosing schedule for each vaccine type is shown in the Table. If the vaccine schedule is interrupted, the vaccination series need not be restarted.

Interchangeability

ACIP recommends that, whenever possible, the HPV vaccination series for females be completed with the same HPV vaccine product.16 If vaccination providers do not know or do not have available the HPV vaccine product previously administered to a given patient, or are in settings transitioning to the 9vHPV vaccine, any available HPV vaccine product may be used to continue or complete the series for females for protection against HPV 16/18, and the 4vHPV or 9vHPV vaccine may be used to continue or complete the series for males.19 There are no data on the efficacy of fewer than 3 doses of 9vHPV.

Concomitant administration with other vaccines

HPV vaccine can be administered at the same visit as other ageappropriate vaccines, such as the tetanus/diphtheria/acellular pertussis (Tdap) and quadrivalent meningococcal conjugate vaccines.16 Giving all indicated vaccines togethe at a single visit increases the likelihood that adolescents will receive each vaccine on schedule. Each vaccine should be administered using a separate syringe at a different anatomic site.

History of sexual abuse or assault

The newest vaccination schedule issued by ACIP recommends that the HPV vaccine be given as early as age 9 or 10 if a child has a history of sexual abuse.23 Studies estimate that 1 in 4 girls and 1 in 20 boys will experience sexual abuse before age 18.

HPV vaccine coverage rates

The HPV vaccine has been available for almost 10 years. Despite its proven efficacy and safety, HPV vaccine coverage rates have been low. In 2012, only 53.8% of 13- to 17- year-old girls had received the first HPV vaccine dose and only 33.4% had completed all 3 recommended doses.24 These rates were substantially lower than HPV vaccine coverage rates in other high-income countries such as Australia and the United Kingdom (71.2% and 60.4%, respectively; Figure).2 More recent reports have indicated some improvement in HPV vaccine coverage rates. For example, in 2014, among girls aged 13-17, 60.0% received at least one dose and 39.7% received the 3 recommended doses.25 The improvement was laudable but insufficient: 6 of every 10 girls in this country are not fully vaccinated against HPV.

Strategies to boost vaccination rates

And, thus, a call to action: Concerted efforts are needed to increase HPV vaccine uptake and achieve its potential to prevent cancers.2 These efforts should promote both initiation of the first dose and completion of all 3 doses for age-eligible adolescents, as well as eligible young adults. What can HCPs do to improve vaccination rates?

1. Keep up to date on what you can do to prevent HPV-related cancers

The CDC launched a new website, HPV: You are the key to cancer prevention, for HCPs so that everything about HPV vaccination is found in one place. The website is easy to navigate; it has only 1 page and 3 tabs: Know the Facts, Commit to the Cause, and Lead the Conversation.26 The recommendations described in items 2, 3, 4, and 6 were also derived from this new CDC website.26

2. Make a strong recommendation

The high coverage rates for the Tdap and meningococcal conjugate vaccines suggest that most preteens and teens are not only going to see their HCP, but they are also getting at least one of the recommended adolescent vaccines.25 However, according to the 2013 National Immunization Survey-Teen, one-third of the parents of girls and more than half of the parents of boys said their child’s HCP had not recommended HPV vaccination—the No. 1 reason for failure to vaccinate their children.27,28 Had the HPV vaccine been administered during visits when another vaccine was given, vaccination coverage for ≥1 dose could have reached 91% by age 13 for adolescent girls born in 2000.25 Evidence shows that an HCP recommendation to get vaccinated is the single most influential factor in determining whether parents gets an immunization for their child!24 HCPs should provide clear and strong recommendations that the HPV vaccine series be given to preteens.

3. Seize the day

Timing is everything.26 Making a strong pitch for preteens to be vaccinated is necessary, but not sufficient. HCPs should take advantage of appropriate opportunities to vaccinate their preteen patients against HPV—for example, during school or camp physical exams—when these patients are still coming in for regular office visits. Once these patients go to college or to work, they are less likely to see their HCP for yearly checkups. To make a timely recommendation, HCPs should do it the same way and the same day that they recommend the Tdap and meningococcal vaccines.

4. Use a reminder system

Reminder systems shown to increase HPV vaccination rates include a reminder letter and direct messaging via automated text, prerecorded voice, and/or postcard.29,30

5. Educate mothers during their routine visits

Another useful strategy is to educate mothers when they are being screened for cervical cancer about the role of HPV infection in cervical cancer. HCPs should explain to mothers that they are undergoing an HPV test to determine whether the virus is present on their cervix, and that their preteen daughters or sons can be vaccinated to be protected from being infected by the HPV types in the vaccine. HCPs can simply say: “HPV is the cause of cervical cancer. We are screening you with the HPV test and the Pap test to detect any existing HPV infection or cervical pre-cancers, which we can then treat to keep them from progressing to cancer. But we can vaccinate your daughters and sons to prevent HPV infection and therefore prevent cervical pre-cancer and cervical cancer.”

6. Address parents’ specific concerns

If a parent’s main concern is side effects, HCPs can say: “Vaccines, like any medication, can have side effects. With the HPV vaccine, the most common side effect is pain and redness at the site of the injection. These symptoms should go away quickly. In addition, the HPV vaccine has not been linked to any serious or long-term side effects.”26 If a parent’s main concern is effect on fertility, HCPs can say, “No scientific data suggest that getting the HPV vaccine has any effect on future fertility. In fact, not getting the HPV vaccine can put a woman’s fertility in jeopardy. Persistent HPV infection can cause cervical cancer, and the treatment of cervical cancer can leave a woman unable to have children. Even treatment for cervical pre-cancer can put a woman at risk for problems with her cervix during pregnancy, causing preterm delivery or other problems.”

7. Hand out written materials

Written materials are helpful in supporting patient education. Patients can refer to them later, after they have spoken to you. Many written materials are available in languages other than English. Spanish-language materials are particularly easy to find. Patient factsheets regarding the HPV vaccine are available on the CDC website.

Conclusion

Considering how effective the HPV vaccine will be in preventing cervical cancer, as well as other HPV-related cancers in both females and males, virtually all preteen girls and boys and all eligible young women and men should be immunized. Vaccination uptake rates, although increasing slowly, are still much too low. These rates will rise dramatically only when HCPs across the country heed the call to action and educate parents about the efficacy and safety of this vaccine and take advantage of opportunities to initiate and complete administration of the 3-dose series.

References

1. Centers for Disease Control and Prevention (CDC). Genital HPV Infection – Fact Sheet. Last updated February 3, 2016.

2. President’s Cancer Panel Annual Report 2012-2013. Accelerating HPV Vaccine Uptake: Urgency for Action to Prevent Cancer.

3. CDC. Clinician Factsheets. HPV Vaccination Information for Clinicians. Page last updated December 29, 2015.

4. Jemal A, Simard EP, Dorell C, et al. Annual Report to the Nation on the Status of Cancer, 1975-2009, featuring the burden and trends in human papillomavirus (HPV)-associated cancers and HPV vaccination coverage levels. J Natl Cancer Inst. 2013; 105(3):175-201.

5. National Cancer Institute. A Snapshot of Cervical Cancer: Incidence and Mortality. November 5, 2014.

6. FDA. June 8, 2006 Approval Letter — Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant.

7. CDC. Clinician Factsheets. Supplemental Information and Guidance for Vaccination Providers Regarding Use of 9- Valent HPV Vaccine. Page last updated December 29, 2015.

8. Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-ofstudy analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012;13(1):89-99.

9. Muñoz N, Kjaer SK, Sigurdsson K, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPVassociated genital diseases in young women. J Natl Cancer Inst. 2010;102(5):325-339.

10. Palefsky JM, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011; 365(17):1576-1585.

11. Herrero R, Quint W, Hildesheim A, et al. Reduced prevalence of oral human papillomavirus (HPV) 4 years after bivalent HPV vaccination in a randomized clinical trial in Costa Rica. PLoS One. 2013;8(7):e68329.

12. Markowitz LE, Liu G, Hariri S, et al. Prevalence of HPV after introduction of the vaccination program in the United States. Pediatrics. 2016;137(3):1-9.

13. Gee J, Naleway A, Shui I, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine. 2011;29(46):8279-8284.

14. Chao C, Klein NP, Velicer CM, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271(2):193-203.

15. Klein NP, Hansen J, Chao C, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012;166(12):1140-1148.

16. Markowitz LE, Dunne EF, Saraiya M, et al; CDC. Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP)MMWR. 2014;63(RR-05):1-30.

17. Drolet M, Bénard É, Boily MC, et al. Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and metaanalysis. Lancet Infect Dis. 2015;15(5):565-580.

18. Romanowski B. Long term protection against cervical infection with the human papillomavirus: review of currently available vaccines. Hum Vaccine. 2011;7(2):161-169.

19. Petrosky E, Bocchini JA Jr, Hariri S, et al; CDC. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the Advisory Committee on Immunization Practices. MMWR. 2015;64(11):300-304.

20. Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711-723.

21. Luxembourg A, Bautista O, Moell er E, et al. Design of a large outcome trial for a multivalent human papillomavirus L1 virus-like particle vaccine. Contemp Clin Trials. 2015;42:18-25.

22. Markowitz L. CDC Expert Commentary. Common Questions About 9-Valent HPV Vaccine. Medscape Pharmacists. June 22, 2015.

23. Advisory Committee on Immunization Practices (ACIP). Recommended Immunization Schedules for Persons Aged 0 Through 18 Years. United States. 2016.

24. CDC. Human papillomavirus vaccination coverage among adolescent girls, 2007-2012, and postlicensure vaccine safety monitoring, 2006-2013—United States. MMWR. 2013; 62(29):591-595.

25. CDC. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2014. MMWR. 2015;64(29):784- 792.26. CDC.

26. Human Papillomavirus (HPV). For Clinicians. HPV: You Are the Key to Cancer Prevention. Page last updated September 30, 2015.

27. CDC. Human Papillomavirus Vaccination Coverage Among Adolescents, 2007–2013, and Postlicensure Vaccine Safety Monitoring, 2006–2014 — United States. MMWR. 2014;63(29):620-624.

28. Newitt VN. HPV vaccination: Are you doing enough to make sure that your patients are protected? Nurse Pract Perspect. 2015;2(4):32-36.

29. Chao C, Preciado M, Slezak J, Xu L. A randomized intervention of reminder letter for human papillomavirus vaccine series completion. J Adolesc Health. 2015;56(1):85-90.

30. Bar-Shain DS, Stager MM, Runkie AP, et al. Direct messaging to parents/guardians to improve adolescent immunizations. J Adolesc Health. 2015;56(5 suppl):S21-S26.

Get your child vaccinated against HPV!

Why does my child need the HPV vaccine?

The HPV vaccine protects against cancers caused by human papillomavirus (HPV). HPV is a very common virus; nearly 80 million people in the United States—about 1 in 4—are infected by it. About 14 million people, including teens, are newly infected with HPV each year. HPV can cause cancer of the cervix, vagina, or vulva in women; cancer of the penis in men; and cancer of the anus or the back of the throat in both women and men.

When should my child be vaccinated?

Your daughter or son should get the HPV vaccine at age 11 or 12. The vaccine is given in three shots. The second shot is given 1 or 2 months after the first shot. The third shot is given 6 months after the first shot.

Why is the HPV vaccine recommended at such a young age?

For the vaccine to be effective, it should be given before a person is exposed to HPV. Exposure to this virus occurs with sexual activity with another person. Most people first engage in sex in their teenage or young adult years. Therefore, it is best to start the vaccination series early—before a person has sex and could potentially be exposed to HPV. Also, the HPV vaccine produces a stronger immune response in preteens than it does in older teens and young adults.

Who else should get the HPV vaccine?

Teen girls and boys who did not start or finish the HPV vaccine series when they were younger should get it now. Young women can get the HPV vaccine through age 26, and young men can get it through age 21. Men between the ages of 21 and 26 who have sex with men and/or who have poor immune systems (including those with HIV infection) can get the HPV vaccine if they did not get it when they were younger.

Is the vaccine still effective if a young person has had sex?

Yes. Even though HPV infection usually happens soon after someone has sex for the first time, a person might not be exposed to any or all of the HPV types that are in the vaccine. Females and males in the age groups recommended for vaccination are likely to get at least some protection from the vaccine.

How well does the HPV vaccine work?

Very well! Clinical trials have shown that the vaccines provide close to 100% protection against pre-cancers and genital warts caused by HPV.

How long will the HPV vaccine provide protection?

Studies show that the vaccine offers protection against HPV infection and HPV-related disease that lasts for at least 8-10 years. The vaccine has been available for only 10 years, so more will be known as time goes on. There is no evidence to suggest that the HPV vaccine loses the ability to provide protection over time.

Will the vaccine require a booster?

In the U.S., the HPV vaccine series requires three shots given over 6 months; booster doses are not recommended. Like all vaccines, HPV vaccine is monitored continually to make sure it remains safe and effective. If protection from HPV vaccine doesn’t last as long as it should, then the CDC will review the data and determine if a booster shot should be recommended.

Does someone need to restart the HPV vaccine series if too much time passes between the shots?

No. If someone waits longer than that the recommended interval between shots, she or he need not restart the series. Even if months or years have passed since the last shot, the series should still be completed.

What are some possible side effects of HPV vaccination?

Vaccines, like any medicine, can have side effects. Many people who get the HPV vaccine have no side effects at all. Some people report having very mild side effects such as pain, redness, or swelling in the arm where the shot was given; fever; headache or fatigue; nausea; muscle or joint pain; and brief fainting spells. Sitting or lying down for 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. On very rare occasions, severe allergic reactions may occur after vaccination.

Will the vaccine cause cancer?

The HPV vaccine cannot cause HPV infection or cancer. By contrast, not receiving the HPV vaccine at the recommended ages can leave a person vulnerable to cancers caused by HPV. Will the vaccine cause my daughter to have trouble getting pregnant later on? No data suggest that the HPV vaccine has an effect on a woman’s ability to get pregnant in the future. In fact, getting vaccinated and protecting against cervical cancer can help women have healthy pregnancies and healthy babies. Not getting the HPV vaccine leaves people vulnerable to HPV infection; for women, this could lead to cervical cancer. Treatment of cervical cancer could leave a woman unable to have children. Even the treatment of cervical pre-cancers caused by HPV can cause preterm labor or problems at the time of delivery.

Readers are invited to photocopy Patient Education pages in the journal and distribute them to their patients.

Resources

Centers for Disease Control and Prevention. HPV Vaccines: Vaccinating your Preteen or Teen. Page last updated January 26, 2015.

Centers for Disease Control and Prevention.Fact Sheet for Parents Questions and Answers. Page last updated December 28, 2015.