Over the last 20 years, there have been several meta-analyses and systematic reviews documenting that NPs provide equivalent primary care when compared with primary care physicians. Patients have also recognized NPs as providing better education and counseling regarding health-related issues.1-3 There are more than 248,000 NPs licensed in the United States with approximately 78% of all NPs working in primary care.4 This places a significant number of NPs at the forefront of recommending, counseling, and ordering vaccinations.
The human papilloma virus (HPV) vaccine has the potential to prevent a significant number of cancer cases. The CDC estimated that approximately 30,700 new cancers were attributable to HPV each year from 2008 to 2012, with over 19,000 occurring among females and over 11,000 among males.5 The rate of HPV-associated cancers increased from 10.8 per 100,000 persons from 2004 to 2008 to 11.7 from 2008 to 2012.5,6 HPV-associated cancers include invasive cancers of the cervix, vulva, vagina, penis, oropharynx, anus, and rectum.6 The HPV vaccine is now approved for prevention of anal cancer.7
Additionally, HPV has been found in squamous cell and nonsquamous cell skin cancers as well as in breast cancer tumors.8,9 A review of 20 studies from 19 different countries showed HPV in 0% to 68% of breast cancer tumors.10 It is not clear whether the presence of HPV is causative in skin or breast cancers, but it is interesting that the virus is found so often in these tumors.
Preventive health maintenance, including routine vaccinations, has historically been well supported by healthcare providers (HCPs) and well received by the general public. The recommendation for hepatitis B vaccine is a prime example of public acceptance of a vaccine as a preventive measure for cancer. The hepatitis B virus was the causative agent in 50% to 60% of hepatocellular carcinoma cases.11
Since this vaccine was introduced, the incidence of hepatitis B declined from 373,000 in 1990 to 17,000 in 2010.12 Unfortunately, there has been significant opposition to the HPV vaccine. Systematic reviews of the literature have identified multiple concerns of HCPs regarding HPV vaccination: negative parental attitudes toward the vaccine, costs, a lack of knowledge regarding effectiveness, inadequate insurance coverage, reimbursement, a preference for immunizing older versus younger adolescents, and a preference to vaccinate girls rather than boys.12-14
Some clinicians may believe that it will be difficult to have patients return for second and, if in a certain age group, third vaccine administrations. This concern can be alleviated, as a recent study showed that a single dose provides some protection, and two doses may be as effective as three doses.15,16
Reviews have also identified parental concerns, including wanting more information before vaccinating children, the vaccine's effect on sexual behavior, and a perception that there was a low risk of HPV infection, particularly among parents of boys. Irregular preventive care is another barrier discussed in the reviews.12-14
Young adults who have not been immunized against HPV have similar concerns as those detailed above.17 These individuals are also concerned about the vaccine's safety and whether it is necessary if they are not sexually active. Men were concerned that the HPV vaccine was not relevant for them.18 A study of young women from rural areas revealed that these women knew little about or were misinformed about cervical cancer, HPV, and the HPV vaccine. They also had environmental and personal barriers, such as transportation, childcare, work, and school.19
The HPV vaccine
The HPV vaccine has been licensed in the United States in three forms. A bivalent form protects against infection with HPV types 16 and 18, which are thought to cause 70% of cervical cancers as well as other genital cancers, anal cancer, and oropharyngeal cancer. The quadrivalent vaccine prevents types 16 and 18 as well as types 6 and 11 (which cause genital warts, a condition that resulted in 353,000 provider visits in 2012).20,21 In December 2014, the FDA approved the 9-valent vaccine that protects against HPV types 6 and 11 as well as oncogenic HPV types 16, 18, 31, 33, 45, 52, and 58.22 As of late 2016, only the 9-valent HPV vaccine is being distributed in the United States.23 The 9-valent vaccine is currently available in a 2-dose and 3-dose regimen.23
The Advisory Committee on Immunization Practices (ACIP) recommendation for the HPV vaccine is that it should be administered to both boys and girls at ages 11 or 12 to ensure protection prior to their sexual debut; it can be given as young as age 9 years.23 The 9-valent vaccine is FDA-approved for both females and males ages 9 through 26 years.22
ACIP also recommends vaccination for females through age 26 years and for males through age 21 years who were not adequately vaccinated in the past; males ages 22 through 26 years may also be vaccinated.23 For individuals initiating vaccination before their 15th birthday, the recommended immunization schedule is two doses of the HPV vaccine. The second dose should be administered 6 to 12 months after the first dose. Individuals over age 15 should receive three doses with a second dose 1 to 2 months after the initial dose and the final dose at 6 months after the first dose.23 The recommendation for the third injection is based on the fact that there are limited research findings on the effectiveness of two doses in those over age 15.
Patient/parent vaccine education
Most patients and parents trust their NPs and follow their recommendations. How the NP approaches the HPV vaccine's administration will likely affect its acceptance.24 Simply saying “your son is due for vaccinations today” is a different message than stating the specific vaccinations that are due and including the HPV vaccine in the list. Parents will pick up on the NP's hesitancy if this vaccine is treated in a different manner than other immunizations.
When dealing with adult patients (ages 18 to 26), a similar approach can be used. Making the HPV vaccine part of a routine vaccine history will desensitize the issue and make it separate from sexual history taking. However, the vaccine should be strongly recommended in the event that there is evidence of sexual activity (for example, a sexually transmitted infection [STI]). If parents or patients want more information, the NP can provide the following evidence-based information that can be used when parents or patients raise concerns.
HPV and sexual activity. A systematic review of literature identified multiple studies, indicating parental concerns that their children, particularly daughters, will be more likely to become sexually active if they receive the vaccine.25 The best evidence against this concern is a study conducted at a managed-care organization that followed 493 HPV-immunized females and 905 unimmunized females for up to 3 years to see if the immunized females had higher rates of pregnancies or STIs; the researchers found no significant differences between the two groups.26
Many adolescents have sexual intercourse, but most are not developmentally prepared to think in a future-oriented fashion to forego sexual activity on the basis that they may get cancer years later. Because research findings suggest that the vaccine does not promote sexual activity, it is important to immunize and protect both those teens who already are sexually active and those who may become sexually active.
Vaccine effectiveness. It takes a while to appreciate the impact of a vaccine that prevents cancer 30 or 40 years after receiving it. However, there is current information that strongly suggests the possibility of the preventive effect of the HPV vaccine. Australia has aggressively advocated that girls and young women receive the vaccine and provides vaccination through its schools. As a result, over 75% of females ages 14 to 17 years and 63% of those ages 18 to 26 years have received the vaccine.27
A study at the Melbourne Sexual Health Centre showed that there was a 92.6% decline in genital warts of patients under age 21 years and a 72.6% decline in those between 21 and 30 years of age within 4 years of the vaccine's introduction in 2007. There was no decline in genital wart rates in women over 30 years of age.
Interestingly, there was also an 81.8% decline in genital warts diagnosed in heterosexual men younger than 21 years of age seen at the clinic, and a decline of 51.1% among 21- to 30-year-old heterosexual males. This happened even though males were not targeted for the vaccine until 2014.28 Clearly, the vaccine is effective against HPV 6 and 11.
Additional data regarding the vaccine's efficacy against the oncogenic types also come from Australia. The rate of Pap tests with high-grade abnormalities declined by more than 50% in women under age 20 years and by about 25% in women between ages 20 and 24 years between the introduction of the vaccine in 2007 and 2012. There was no decrease in abnormalities for women over age 30 years, the age group that was not targeted by the vaccine program.29 A similar reduction in abnormal Pap tests in young women was found in Denmark where the HPV vaccine has been widely used.30
A study of immunized, high-risk young women in the United States showed a 78% reduction in HPV types 6, 11, 16, and 18 when compared with historical controls.31 The National Health and Nutrition Examination Survey (NHANES) collected self-administered cervico-vaginal specimens from a random sample of households from 2003 to 2006 and again in 2009 to 2012. The presence of vaccine-preventable HPV among females ages 14 to 19 years decreased from 11.5% (2003 to 2006) to 4.3% (2009 to 2012) and from 18.5% to 12.1% among females ages 20 to 24 years; there were no significant declines in other age groups.32 Therefore, it seems clear that the vaccine is effective in reducing the likelihood of acquiring genital warts as well as the two oncogenic viruses that cause 70% of cervical cancers.
Age for immunization. Some parents do not wish to immunize their children prior to adolescence because they are not sexually active. In these cases, it is necessary to point out that the best time to immunize is before there is a likelihood of infection. Waiting until someone is sexually active before immunizing against HPV is similar to saying that one should not receive the measles, mumps, and rubella vaccine until after they have had measles.
Furthermore, HPV is an infection of skin and mucous membrane cells and is transmitted from skin to skin or from mucous membrane to mucous membrane. Therefore, transmission can occur during nonsexual events. Genital warts have been found in women who were found to have intact hymens.33 HPV has also been recovered from the fingertips of 30% of female college students in one study.34 As mentioned above, HPV-associated cancers are located at several sites other than the genitals.
Immunization of males. Both young men and parents of boys will raise the question, “Why should males be immunized when the vaccine prevents cervical cancer?” Parents and young men should be educated about the cancers that do not involve the cervix and the risk of males to acquire them. As described above, HPV can cause penile cancer, oral cancer, and anal cancer. For example, pointing out that a male's HPV infection status may put the mother of his future children at risk for these cancers, and for cervical cancer, promotes thought-provoking consideration.
Vaccine safety. Concern of potential adverse events has been raised by both parents and by 18- through 26-year-old women for whom the vaccine is recommended. One study of 244 women between 18 and 24 years old found that 22% were concerned about the vaccine's safety.35 There is an extraordinary amount of information that attests to the safety of the vaccine.
No pattern of serious adverse reactions or causes of death have been attributed to the vaccine; however, like any vaccine, there will be some individuals who will experience pain, redness, or swelling in the arm where the injection is given. Other possible adverse reactions may include fever, headache or feeling tired, nausea, and muscle or joint pain.14 The most common potentially harmful event is fainting. This was recorded in 3 out of 1,000 individuals receiving the HPV vaccine in clinical trials, which was equal to those who received placebo injections.36 Nonetheless, it is recommended that the injection be given while the recipient is seated and that they remain seated for 15 minutes afterward.
Vaccination of postadolescent women. Some 18- to 26-year-old women will question whether they should be immunized because they are not sexually active. As mentioned above, the ideal time to be vaccinated is before exposure. Women who are beginning to have sex are at significant risk of HPV infection. A study showed that 28.5% of women acquired HPV infection within 1 year of having sex with their first partner. If they were with that partner for 3 years, this risk approached 50%.37
However, it should also be pointed out that HPV has been recovered from the genitals of virgins and is regularly found in the oral cavity.38,39 The NHANES study collected oral swabs from a representative study of Americans and found that 5.6% of the individuals between the ages of 16 and 69 years were positive for HPV. Although the risk was higher for those who admitted to having oral sex, it was present in those who denied that behavior.40
Vaccine costs. Vaccination costs are a routine concern to both HCPs and those receiving the vaccine. The Patient Protection and Affordable Care Act requires that all insurers cover any vaccines that were recommended when the act was passed for individuals who are 0 through 18 years of age.41 At the time the act was passed, the HPV vaccine was only recommended for females; therefore, young males are not covered by this provision. However, some insurance companies will pay for male vaccines, and patients should contact these insurance companies to learn their coverage provisions.
In addition, the HPV vaccine is covered for both males and females by the Vaccines for Children Program, which provides vaccines at no cost to children up to age 18 years who are uninsured, underinsured, or have Medicaid or Children's Health Insurance Plan.42 NPs should make certain that their practice participates in this program so that their patients are eligible. And, even if they cannot obtain funding for immunizing young males, the Australian data show that if young women are immunized, young heterosexual men will be far less likely to acquire HPV infections.
From a medical and public health perspective, it is surprising that a vaccine that prevents cancer is not as widely adopted in the United States as has been in other countries. A potential explanation for this is that clinicians have not been advocates for the vaccine. A nationwide survey of 776 family practitioners (47%) and pediatricians (53%) showed that 27% of the physicians reported they do not strongly endorse the HPV vaccine or routinely recommend it for 11- to 12-year-old girls (26%) or boys (39%).24 Most of these physicians (59%) use a risk-based approach to recommending the HPV vaccine. The quality of HPV immunization recommendations was lower among physicians who were uncomfortable talking about the HPV vaccine or who believed parents did not value it.
Pediatricians (54%) were more likely to follow recommendations for HPV immunizations than family physicians (37%).23 While this means that pediatricians outperformed family physicians, it also means that nearly half of pediatricians surveyed were not advocates of the HPV vaccine. A more recent study showed some improvement in recommending the HPV vaccine. A survey of pediatricians (n = 364) and family practitioners (n = 218) showed that 60% of pediatricians and 59% of family practitioners strongly recommend the HPV vaccine for 11- to 12-year-old girls, whereas 52% of pediatricians and 41% of family practitioners strongly recommend the vaccine for 11- to 12-year-old boys.43
Again, it is useful to point out that 40% of pediatricians and family practitioners do not follow the vaccine recommendations for girls and half or more do not follow them for boys. NPs have also been found to not follow vaccine recommendations. A survey of 575 primary care providers whose practices included adolescents (47% family medicine physicians, 20% pediatricians, and 33% NPs) found that only 76% of these clinicians said that they recommend the vaccine more than 75% of the time to their 11- to 12-year-old female patients, and less than half were likely to recommend it for boys of that age.
Pediatricians were slightly more likely to recommend the vaccine for their female patients than family practitioners or NPs. However, there was a much larger difference in recommending the vaccine for boys between pediatricians (67% of the time), family practitioners (42%), and NPs. (41%).44 The importance of provider recommendations was illustrated in a study of 18- to 26-year-old women in which the women demonstrated they were three times more likely to take the HPV vaccine if their physician strongly recommended it as opposed to having a lukewarm recommendation.45
Given the effectiveness of the vaccine to prevent cancer and genital warts, providers should now be more proactive in using the vaccine. Providers should no longer let the fear of offending parents or patients hinder the vaccine from reaching its full potential. Although more research needs to be done to determine the most effective counseling messages, there are suggested topics to cover based on the clinical experiences of the authors (see Counseling patients and parents).
Knowing that patients see NPs as better educators and counselors as compared with their physician counterparts, NPs should take leadership in advocating for, counseling about, and administering the HPV vaccine. It is particularly important that this occur, as the number of NPs is now approaching the number of primary care physicians and will soon represent the majority of primary HCPs in the United States.4 Therefore, NPs will be a powerful force in reducing future cancers and to significantly reduce the 353,000 visits for genital warts that occur annually.
- HPV is transmitted by skin-to-skin or mucous membrane contact. Because HPV can be acquired without penetrating vaginal or anal sex, virginity or monogamy are not totally effective prevention strategies.
- Planning to be a virgin at the time of marriage does not guarantee a future partner is not infected or will not become infected.
- There are rumors that the vaccine is given with large needles and the injection site pain increases with subsequent doses. The needle size fear can be allayed by showing the actual needle that is being used. Emphasize that the same-sized needle is used each time in order to increase the potential that the patient will return for the second and third doses.
- Using a condom decreases the chance of contracting HPV; however, the HPV vaccine is much more effective, as condoms do not always cover skin infected with HPV (for example, the scrotum).
- Emphasize that the HPV vaccine protects against certain HPV types that cause some cancers (including a majority of cervical cancers) and against the HPV types that cause genital warts. It does not protect patients from any other STIs, including HIV infection. Encourage patients to use condoms.
- It may be useful to show pictures of HPV warts. There are many sites on the web that illustrate these lesions (www.dermnetnz.org/viral/genital-warts-imgs.html).
- Young women who are already sexually active and/or have had abnormal Pap tests or genital warts can still benefit from the 9-valent vaccine, as it may protect against HPV types that they have not yet been exposed to.
- Young women need to know that the vaccine is not a replacement for cervical screening but is an added tool for prevention of cervical cancer. They are complementary and not competitive.
- Young women also need to know that Pap tests are not a preferred alternative to the vaccine. Pap tests are time-consuming, expensive, may be worrisome, and have both false-positives and false-negatives.
- Young men need to know that not only are they protecting themselves from warts and cancer, they are also helping to protect their partners. This is true for women as well.
- Reassure parents that the vaccine does not increase sexual activity or make it more likely.
- Explain to parents that it is best to give the vaccine prior to their child being exposed, just like all vaccines.
- Reassure parents and patients that the vaccine is just as safe as other routine vaccines.
- Give a strong recommendation for the vaccine; do not separate it or offer it differently.
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