Table of Contents
Title Page……………………………………………………………………………………… 1
Table of Content………………………………………………………………………………. 2
Thesis Overview………………………………………………………………………………. 4
Research Problem……………………………………………………………………… 6
Research Question…………………………………………………………………….. 6
Purpose of Research…………………………………………………………………… 7
Human papilloma Virus (HPV) is the most common sexually transmitted infection in the United States, affecting more than 80 million individuals, mostly young teens and adults. Each year more than 14 million individuals become newly infected. There are over 150 different strains of HPV ranging from genital warts to malignancy. In 2006, the FDA approved a vaccination to prevent certain HPV strains; Gardasil ®. Since then, the FDA has created two other HPV vaccinations, Cervarix ® in 2007 and Gardasil 9 ® in 2014. Due to the creation of the HPV vaccinations, the incidence rates of HPV infections have decreased significantly, but incompletion of the vaccination series, as it is needed in more than one dose, is a concerning health issue as a large number of adolescents and young adults are not following up with the subsequent doses. There is little research on the link between where the barriers are originating and the high rates of incompletion of the vaccination as it is a more innovative vaccine that has not been on the market for a long duration of time. The HPV vaccine stimulates the body to produce antibodies that will protect cells from getting infected before future exposure. Receiving only one dose of the series does not mount a full immune response and can lead to a vulnerable individual. Completing the series before exposure to the virus is important to get the best prevention of HPV infections or HPV- related cancer. The HPV vaccine is unique because it is a breakthrough prevention therapy for certain types of cancer.
HPV is a sexually transmitted infection that can be harmless, but strains of the virus can cause cellular changes that lead to genital warts or cancer of the cervix, vagina, vulva, penis, anus, and oropharynx. Low and high risk strains are classified by their likelihood of developing cancer after an infection. Low risk strains, 6 and 11, cause 90% of genital warts while high risk strains, 16 and 18, cause 70% of cervical cancers. Other high risk strains include 31,33,45,52, and 58. Gardasil ® protects against 4 strains of HPV while Cervarix ® protects against 2. In 2014, Gardasil 9 ® was approved by the FDA which protects against 9 strains.
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As of 2017, Gardasil 9 is the only HPV vaccine available for use in the United States. Gardasil 9 ® is 9- valent vaccine which protects the body against nine strains; 6, 11, 16, 18 ,31, 33, 45, 52, and 58. It does not eliminate the need for recommended screening for cervical cancer starting at age 21. Although this vaccine is not required, it is strongly recommended. The Centers for Disease Control and Prevention previously recommended a 3- dose vaccine series to all ages 9- 45 in 2015. As of October 2016, a 2- dose vaccine series is recommended to all children aged 9 to 15 on a 0 and 6- 12 month schedule and a 3- dose vaccine series to all children starting the series on or after their 15th birthday on a 0, 1 to 2, and 6 month schedule. 1 While the recommendation does not include individuals over the age of 45, some believe that it can be beneficial on a case by case basis.
The HPV vaccinations are recombinant in nature. The vaccines are composed of noninfectious virus – like particles (VLPs) that are on the HPV cell surface. VLPs closely imitate the natural HPV virus and are not infectious because they do not harbor the virus’s DNA. The VLPs then induce antibody production in the body stimulating an immune response. Once an appropriate immune response is mounted the body can be protected. With exposure to the HPV virus, antibodies can recognize the virus as foreign and are able to neutralize harm before an individual is infected. 2
As of 2016, from the pre- vaccination era before 2006 to the post- vaccination era, there has been a 64% decreased in the prevalence of HPV infections.3 Despite these outstanding results, based on data from 2011 to 2015, about 42,700 HPV- associated cancers occur in the United States each year with 24,400 cases affecting women.4 Cervical cancer mortality and incidence rates are consistently higher among underserved communities due to lack of continual access to primary care and follow up. Individuals may not be diagnosed or treated until an advanced stage leading to financial burdens or unfortunately, death. Increasing awareness of the vaccination and it’s benefits in these communities specifically and all individuals is essential before exposure is established through sexual contact.
A disparity exists with the vaccine; as many individuals are completing their first dose of the vaccination series, depending on their age, one or two more doses are required for completion and these subsequent doses are not being completed. In 2017, the CDC stated that only five out of ten adolescents are up to date on their HPV vaccine.1 Implications of not receiving the full series of the HPV vaccination are daunting as the body will become a vulnerable host. The first dose of the 2 or 3 dose series does not provide as much immunity as possible. Therefore, more than one dose is needed for adequate protection. Blomberg et al found that with each additional dose of the vaccine there was a significantly lower incidence of genital warts observed.5 Additionally, Mishra et al performed a clinical trial measuring titers of the vaccination and found that the highest immune responses detected were in girls aged 9 to 15 after the recommended age- related doses of the vaccine.6 It is imperative for Physician Assistants to understand the consequences of incompletion and help patients become more aware of the benefits of the HPV vaccination. Targeting special populations that are identified as significant barriers including underserved geographic areas, ethnic disparities, cost, parental decision making, and health care providers influence can help to increase uptake rates.
Healthy People 2020 has named one of its goals to this particular subject, stating that their goal is to have 80% of adolescents completing the vaccination by age 15.7 Since the vaccine is relatively new to society, little quantitative research has been done on barriers that exist with HPV vaccination uptake but qualitative research has been on the rise to help determine this existing health concern.
Human papillomavirus virus infection is the most common sexually transmitted infection in the United States and since the discovery of the vaccination, there has been a breakthrough in preventative therapy for genital warts and HPV- related cancers. It is important for young adolescents to be vaccinated before they become sexually active and are exposed to the virus. The field of medicine has a chance to protect future generations from a common infection and more importantly, malignancy. There has been a need for further knowledge on the barriers that are affecting the completion of the vaccination series as more than half of adolescents in the United States have not completed the required doses.
The questions specific to this research reflect the need for awareness of the implications regarding the effects of incompletion of the HPV vaccination and the obstacles that are directly affecting its uptake. What are the most common barriers leading to decreased uptake of the HPV vaccine? What is the barrier that is most concerning to the decreased uptake of the vaccination? Why isn’t the HPV vaccination treated like the others recommended vaccinations (Tdap, Meningococcal) that are due at the age when HPV is recommended? What barriers can be easily changed? How can we change the outlook of this particular vaccine in order to help decrease the incidence of HPV associated infections and cancer in young adults?
This research is organized around the hypothesis that the HPV vaccine has certain barriers impinging on its series completion which will be further discussed in this literature review. HPV- related infections and cancers are a public health concern nationwide and factors affecting its uptake need to be further analyzed. Although many barriers will be presented, it will be evident at the conclusion of this paper that more research will need to be conducted in order to ameliorate the obstacles that stand in the way of the HPV vaccination uptake.
Purpose of Research
The purpose of this research is to elaborate on the obstacles facing HPV vaccination uptake. This research will review existing literature to determine detrimental factors affecting the uptake of the HPV vaccination series. Understanding the target barriers and where they originate will allow for better patient education on the vaccine to protect young adolescents and adults from acquiring the HPV infection before potential exposure to the virus and how to effectively target certain populations that require more education and follow up communication. It will also discuss implementations and future guidelines to improve the vaccination uptake.
Data for this research was obtained through peer reviewed journals such as JAMA and Cancer Epidemiology, Biomarkers & Prevention. Most articles were obtained from article database search engines such as Science Direct and NCBI. The medical guidelines used, and vaccine recommendations are following the Centers for Disease Control and Prevention and The American Cancer Society guidelines.
Geographic Location and the HPV Vaccination
Rural and urban communities play a critical role in access of healthcare. Underserved communities have constantly faced obstacles with receiving adequate health care. The percent of uptake of the HPV vaccination in 2017 was 11 points lower in rural areas compared to urban areas. ^6^ The Geographic Health Equity Alliance addresses many obstacles rural communities stating that they tend to be older, poorer, less educated, less likely to have health insurance, and more likely to experience transportation difficulties.8 These obstacles have created a vicious cycle within generations of the rural communities.
In the United States, incidence rates of each HPV- associated cancer were highest among women living in census tracts with poverty greater than 20% compared to those living in poverty levels of less than 5%.9 Lack of annual primary care and screening are correlated with those results. Screening for cervical cancer starts at age 21 and needs to be repeated every 3 years until the age of 65 and screening alone cannot prevent an individual from getting infected with HPV. As the recommended age of vaccination is from 9 to 11, it is important to make parents aware of the fact that once their child is potentially infected through sexual contact, the vaccine loses its value, so it is imperative to receive the completed series before any exposure.
Although there is a wide disparity among rural and urban health care, studies show that there is resilience among these individuals. Rural communities have strong multigenerational families and linked community networks that serve as informational support services.8 This has created an increase in concentration of individuals with the same health related concerns leading to participating in positive interventions. Vaccination for Children (VFC), a federally funded program has helped these families that have no health insurance or cannot afford the vaccination. A focused effort has been made because of the known increased rates of infection and cancer in these areas.
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Measures continue to be taken to provide access to health care and vaccinations to the rural communities and a change in our nation’s health care system could potentially stop the generational vicious cycle, positively impacting these individuals. But, as of today, this particular barrier to the HPV vaccination is part of a nationwide health access disparity issue and will be difficult to overcome.
Ethnicity, Race and the HPV Vaccination
Cervical cancer disproportionately affects ethnic minorities, African Americans, immigrants, and those with lower income. ^12^ These individuals would benefit most from initiating and completing the HPV vaccination.
There is conflicting research about specific ethnicities and races and their correlation to HPV vaccination uptake. Bastani et al found that in a sample of 490 girls aged 9 to 15 consisting of ethnic minority and immigrant women, 29% of daughters from ethnic minorities initiated the vaccine with only 11% completed the series. 10 Among all the girls, only 12% had completed the vaccination series. During their study in 2011, they found that there were notable differences in the awareness of the vaccine, not knowing there was a vaccination available. 10 Although this study was relatively small, it showed the vast majority of girls not completing the vaccine.
In a study conducted by the American Academy of Pediatrics, 3,297 females aged 9 to 26 who had initiated the vaccine were retrospectively studied as a cohort. They found that white race compared with black race was independently associated with higher odds of vaccination completion within 7 months and 12 months.11 Adherence and completion rates were found to be low, exacerbating the rates of HPV related cervical cancer.
On the contrary, Kevin Henry et al found that Hispanics with a percent of 69 and non- Hispanic Blacks with a percent of 54 initiated the vaccination compared with 49.9 percent of non- Hispanic whites.9 This study was on 20, 565 girls aged 13 to 17.9 Conflicitng evidence arises between the studies but due to the larger cohort, Henry et al has a superior study. This could be due to the age group as most of the girls in this study were eligible for the Vaccination for Children foundation.
Despite the conflicting research between the years, evidence shows that awareness and education should still be the highest priority among all races and ethnicities to initiate and complete the HPV vaccination due low uptake levels in all aspects of race and ethnicity. With evidence showing that increased rates of HPV- related cervical cancer are higher among ethnic minorities and African Americans, these individuals remain target population and will present as a significant barrier due to lack of access to care and lack of insurance. Due to their limitations in health care, one visit may be the only time a healthcare provider can initiate a conversation about the HPV vaccination and its benefits. Every chance for education and awareness should be sought after in a clinical setting especially with the known higher incidence rates of cervical cancer within the minority races and ethnicities.
The HPV Vaccination as an “Advanced” Innovation
This vaccine poses a new problem in society, as it is relatively new with the latest vaccine, Gardasil 9 ® being approved in 2014. As society is shifting to a fear of vaccination safety and efficacy in general, newer vaccines are being disregarded. It is unfortunate because the health care field now has a tool to prevent serious infections and invasive cancers potentially eradicating the most common sexually transmitted infection for the next generation of young adolescents.
Compared to meningococcal (MCV4) and Tdap (tetanus, diphtheria, acellular pertussis) vaccinations, the HPV vaccination is not required for school purposes, but it is still recommended as a routine vaccination. At 11 and 12 year old, the CDC recommends a child to receive all 3 vaccinations. Tdap and MCV4 vaccines were developed early in the 20th century, making them well known to our society with proven efficacy and safety. Since Tdap and MCV4 vaccinations are not associated with direct sexual contact, parents are weary of the impact the HPV vaccine would have on their child. Since children at this age are minors, parents will make the ultimate decision about vaccinations until age 18. Vaccination at ages 11 and 12 years targets adolescents at an age when most are not sexually active yet and also when immune response to the vaccination is greatest.12 A key educational point to relay to parents and caregivers is that the CDC wants children to receive all doses before any sexual contact begins in an adolescents life, inhibiting the virus all together.
With the fear rising in our society of all vaccinations, a study done by BMC Public Health found that adolescents and their caregivers expressed concerns about HPV being an untested, “newer” vaccine and needed more information before they would receive the vaccination.13 Among populations where their access to care was limited, many found that coming back for multiple visits was a burden especially if they could not cover the cost. In 2013, a study in New York indicated that for every study year from the introduction of the HPV vaccination, the proportion of Tdap vaccination visit that included co- administration of MCV4 was greater than co- administration of the first dose of HPV (P < 0.001) in 11 year old children.14 By age 17, Tdap and MCV4 vaccination coverage continued to increase whereas the uptake of the HPV vaccination in this same cohort differed by 20 percentage points below those values.14 This could be due to many contributions as cost, multiple visits, and loss of follow up from the healthcare offices.
With an open conversation, a provider should address the concerns of the parent or caregiver by providing adequate education, ways to reduce the cost with federally funded programs especially when their child is still young and implementing more follow up phone calls provided to patients for reminders and to those that have already received one dose of the HPV vaccination.
Physicians Influence on the HPV Vaccination
Physicians are responsible for initiating the correct and recommended care for all patients without discrimination or personal perception. Research suggests that a physician’s recommendation is a strong influencer in whether or not the adolescent or young adult females should receive the HPV vaccination and parents rely on their healthcare provider to provide them with the most up to date information. According to a research on provider influence there was unsupportive recommendations for the HPV vaccination in all aspects of communication including method, content, style, timeframe, and context.15 Despite parents and caregivers reporting that they would like to receive unambiguous and unbiased recommendations for the vaccine, physicians continued to provide families with mixed messages by failing to endorse the HPV vaccine differentiating it from other vaccine and saying it was “optional”.15 Autonomy is the right for patients to make decisions about their own medical decisions and with unambiguous information and the trust they put in the physician, the result has been negative on the initiation and uptake of the HPV vaccine at the physicians fault.
Physicians also failed to be the source of the information on vaccine putting the nurses and front desk employees in charge of informing patients about the HPV vaccine. Many patients reported that they did not take the advice because they put more trust in their physician that knows their personal medical history. Also, physicians who “perceived” parents as unsupportive of the vaccination or could not effectively communicate due to language barriers, were less likely to recommend it.15 It is a physician’s duty to be unbiased in all aspects of care, giving equal opportunity to every patient.
The audience and time frame that physicians were taking was also aimed in the wrong direction. Providers recommendations for the vaccine increased with patient age which was older than what the CDC recommended for the vaccination. This is unfortunate because the science of the vaccine, as stated before, works only before exposure to sexual contact. Also, recommending the dose at earlier age, particularly before age 15, eliminates the need for three doses which cuts back on cost and visits to the health providers office. This could lead to increase in uptake of the vaccination.
Lastly, the style of context of physician’s communication was heavily researched. Strong endorsement of the vaccination increased rates of the vaccine initiation and uptake of the vaccine but many physicians failed to endorse or even recommend the vaccine. Parents reported that if the physician distinguished the HPV vaccine from others at that age (Tdap and MCV4) as “optional” there was increased hesitancy and decreased initiation but if they recommended the vaccine as “routine” as with the other vaccinations, there was low levels of hesitancy that led to increased initiation and continued uptake.15
Based on the findings of this research, physicians themselves may need more information on the HPV vaccination and how to effectively communicate with their patients by being unbiased and recommending all vaccines equally. Physicians recommendations are where the original message of the HPV vaccination is set into place and should be communicated in a collaborative approach. As parents are requesting clear, unambiguous messages about the HPV vaccine, physicians have the duty to provide the information regardless of their beliefs.
Implications for the PA Profession
The ability to inform patients of up to date medical advice and recommendations is a Physician Assistants responsibility especially as the profession is growing in the United States. On some visits into an office or medical center, a patient may only have an interaction with a PA and not a physician. The ability to communicate effectively with an unbiased opinion about vaccinations is imperative to increase the rates and uptake of the HPV vaccination. By understanding that there are barriers to the vaccine will help PAs target certain populations that may be unaware or uneducated on the HPV vaccine. Also, by knowing that patients are putting their trust in their provider to ensure quality care and relying on them to initiate conversation about the HPV vaccination and recommendations will help eliminate the communication barrier that exists between patient and provider.
Strengths of Research
Analysis of the articles used for this research exhibited many strengths. Large cohort studies were conducted within the last 5 years in published journals which ensures up to date information. Many of the articles discussed individuals that have completed the vaccine and those who did not which created an unbiased platform of research allowing for an accurate comparison.
Weaknesses of Research
There were also many weaknesses in the articles reviewed as the HPV vaccination was introduced in 2006. The vaccination that include the most protection was introduced in 2014, leaving only 5 years of research available. Small sample size and information that is 5 years or older could give misinformation of the subject as vaccination beliefs have wavered in our society. Another drawback to the research was due to phone calls or surveys that were conducted which may have skewed the data.
Recommendations for Future Research
Future research is dependent among health care providers and raising awareness of the HPV vaccination nationwide. To be compared to rates with other vaccinations, the HPV vaccine could be considered “required” for school enrollment like Tdap and MCV4 or another option would be to create a vaccine that requires only one dose. Initiation has declined due to providers influence and lack of awareness of the vaccine and its efficacy. Loss of follow up was mainly due to cost, lack of access to care to receive the next doses, and no health care provider office follow up phone calls.
Human Papilloma Virus is affecting many women worldwide today whether it be a mild infection or invasive cancer. Since the creation of Gardasil 9 ® the medical field has an opportunity to potentially eradicate HPV from future generations and decrease cancer rates. Health care providers need to be aware of the incidence rates of this sexually transmitted infection and effectively guide patients through the CDC’s current recommendations based on age, dosing, and cost. Clear communication and initiation of conversations about the HPV vaccination should be implicated at the appropriate times in a child’s care.
As the research suggests, there are many barriers to initiation of the vaccine and the uptake of subsequent doses. Reaching out to underserved communities and targeting minority races and ethnicities is important in preventing the increase of cervical cancer rates in women. Uptake rates can be influenced by calling patients for follow up doses and always checking records before patient departure. This can help inform the patient on dates of redosing or if the correct time has passed, a dose at that particular visit date. As the vaccine is an advanced science, benefits of the vaccine prevention and future studies that show the vaccine’s efficacy and safety will help providers show patients that they will be protected. All healthcare providers make an impact on every patient they interact with and words said about treatment and vaccinations could be the only time certain patients could be hearing the information to make the best decision about their care. It is imperative for clinicians to provide unbiased and clear information regrading the HPV vaccination by communicating effectively allowing questions to be answered and information to be correctly understood.
Future generations have a breakthrough in prevention therapy with the HPV vaccination. Incidence rates have declined significantly with the creation of the vaccination and will continue to do so with future research and optimization of clinician and nationwide awareness. Further research on the obstacles that are creating a disparity in initiation rates and uptake of the HPV vaccine will continued to be studied and hopefully be impacted in a positive way leading to increased rates.
- HPV Vaccination Coverage. CDC. August 2018. https://www.cdc.gov/hpv/hcp/vacc-coverage/. Accessed June 12, 2019.
- Zhao Q, Potter CS, Carragher B, et al. Characterization of virus-like particles in GARDASIL® by cryo transmission electron microscopy. Human Vaccines & Immunotherapeutics. 2013;10(3):734-739. doi:10.4161/hv.27316.
- NCI Staff. HPV Infections Decrease in the U.S. National Cancer Institute. https://www.cancer.gov/news-events/cancer-currents-blog/2016/hpv-infections-decreased. Published March 9, 2016. Accessed July 1, 2019.
- HPV-Associated Cancer Statistics | CDC. Centers for Disease Control and Prevention. https://www.cdc.gov/cancer/hpv/statistics/index.htm. Published August 29, 2018. Accessed July 1, 2019.
- Blomberg M, Dehlenorff C, Sand C, Kjaer SK. Dose-Related Differences in Effectiveness of Human Papillomavirus Vaccination Against Genital Warts: A Nationwide Study of 550,000 Young Girls. Clinical Infectious Diseases. 2015;61(5):676-682. https://www.ncbi.nlm.nih.gov/pubmed/25944340. Accessed June 14, 2019.
- Mishra GA, Pimple SA, Shastri SS. HPV vaccine: One, two, or three doses for cervical cancer prevention?. Indian Journal of Medical and Pediatric Oncology. 2015;36(4):201–206. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4711216/. Assessed June 13, 2019
- Immunization and Infectious Diseases. Immunization and Infectious Diseases | Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives. Published July 12, 2019. Accessed July 1, 2019.
- Weaver, K, Strom, C, et al. Call to Action: Addressing Rural Cancer Health Disparities, 2016. http://www.nohealthdisparities.org/. Accessed June 20, 2019.
- Henry KA, Stroup AM, Warner EL, Kepka D. Geographic Factors and Human Papillomavirus (HPV) Vaccination Initiation Among Adolescent Girls in the United States. Cancer Epidemiology, Biomarkers & Prevention. http://cebp.aacrjournals.org/content/early/2016/01/11/1055-9965.EPI-15-0658. Published January 14, 2016. Accessed June 13, 2019.
- Roshan Bastani, Beth A. Glenn, Jennifer Tsui, L. Cindy Chang, Erica J. Marchand, Victoria M. Taylor and Rita Singha. Understanding Suboptimal Human Papillomavirus Vaccine Uptake Among Ethnic Minority Girls. Cancer Epidemiol Biomarkers Prevention. July 1 2011 (20) (7) 1463-1472; http://cebp.aacrjournals.org/content/20/7/1463.full-text.pdf. Accessed June 11, 2019
- Widdice LE, Bernstein DI, Leonard AC, Marsolo KA, Kahn JA. Adherence to the HPV vaccine dosing intervals and factors associated with completion of 3 doses. Journal of the American Academy of Pediatrics. 2011;127(1):77–84. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3010090/. Assessed June 10, 2019.
- Holman DM, Benard V, Roland KB, Watson M, Liddon N, Stokley S. Barriers to Human Papillomavirus Vaccination Among US Adolescents: A Systematic Review of the Literature. JAMA Pediatrics. 2014;168(1):76–82. https://jamanetwork.com/journals/jamapediatrics/article-abstract/1779687. Assessed June 11, 2019.
- Ingrid T. Katz, Laura M. Bogart, Yingna Liu, et al. Barriers to HPV immunization among blacks and latinos: a qualitative analysis of caregivers, adolescents, and providers. BMC Public Health. https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3529-4. Published August 25, 2016. Accessed June 14, 2019.
- Sull M, Eavey J, Papadouka V, Mandell R, Hansen M, Zucker J. Adolescent Vaccine Co-administration and Coverage in New York City: 2007-2013. Pediatrics. 2014;134(6). doi:10.1542/peds.https://pediatrics.aappublications.org/content/134/6/e1576.abstract?sid=ac2f74df-0f78-4de5-9fa7-3acab9838974. Accessed June 15, 2019.
- Gilkey MB, Mcree A-L. Provider communication about HPV vaccination: A systematic review. Human Vaccines & Immunotherapeutics. 2016;12(6):1454-1468. doi:10.1080/21645515.2015.1129090. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4964733/. Accessed July 5, 2019.
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