A disproportionate cervical cancer burden persists for women living in Appalachia. The reason for this continuing public health problem is multifaceted and includes many of the social determinants of health that have been described by Marmot and Wilkinson [26
]. The development and distribution of the HPV vaccine is important to women living in Appalachia because it protects against infection with high-risk HPV types 16 and 18, which cause more than 70% of cervical cancers [5
]. Since HPV is a sexually transmitted infection (STI), various concerns about the HPV vaccine have emerged including sexual politics (young women’s bodies and behaviors), parental rights, costs, efficacy and safety, and cultural attitudes [27
]. These concerns have been raised and brought to the general public’s attention by advocates who have suggested mandating HPV vaccination in the U.S. [27
To our knowledge, this is the first study to provide information regarding the HPV vaccine availability in public health departments across multiple Appalachian states where the cervical cancer burden is disproportionately high. This is important because health departments provide medical care to many of the residents living in Appalachia [32
]. Overall, there was variation within and among state health departments for most of the information documented in this study. Differences occurred relative to the level at which HPV vaccine policy decisions were made (state, district/region, county, city), vaccine availability, providers’ recommendations for the vaccine, patient costs, the availability of financial assistance, and the educational materials used by the different public health departments. Although some variation among states was expected, the variation within states was not predicted, especially the HPV cost differences among health departments within one state for females who do not qualify for the VFC program.
Results of this study also raise policy issues regarding provision of the HPV vaccine by public health departments. For example, in Pennsylvania, females who do not qualify for the VFC program because of age are referred to other providers and the cost of the vaccine is covered by public assistance or on a sliding scale. In other states, some public health departments limit the HPV vaccine solely to patients who are eligible for the VFC program. The vaccine cost ranged from being free of charge to $160 per dose at public health departments within one state (if the patient does not qualify for the VFC program). Some health departments provided financial assistance for the vaccine while others provided no assistance. These data suggest that health departments located in Appalachia do not provide the vaccine to all women who are eligible to receive it. Thus, access to the HPV vaccine is limited to many women who would benefit most from being vaccinated.
Other interesting findings in this study are that some health departments reported that they provided the vaccine to women under the age of 18 years without parental permission and other departments reported providing the vaccine to women over the age of 26 years. Both practices are contrary to the current FDA approved guidelines for the HPV vaccine [17
]. Although these practices are probably occurring elsewhere, there are no reports to document this in the scientific literature. In one survey study, pediatricians were more likely to support vaccination without parental permission than the general public (77% vs. 47%; p<0.001), but this study did not report actual practice patterns of the pediatricians [33
]. The clinical benefit of vaccinating women older than 26 years of age is less clear based on cost-effectiveness data [34
]. Although women may receive the vaccine “off label,” it is important to note that insurance companies are unlikely to cover the cost of the vaccine among women in this age group [35
The findings of this study highlight the potential complexity of developing policies about the HPV vaccine in a geographic region where the cervical cancer burden is high. Currently, there is legislative activity in many states focused on many issues including but not limited to mandating the HPV vaccine for school enrollment (with parental right to opt out provision), mandating insurance coverage, state funding to support vaccination and to develop public awareness campaigns and educational programs. If the HPV vaccine is required by law, it is predicted that the vaccination rates would probably increase substantially similar to the increased vaccination rate for the hepatitis B vaccine after requiring it by law [37
]. Failure of previous legislative attempts to require the HPV vaccine have been influenced by lack of knowledge about the vaccine, lack of long-term results, negative feelings toward the pharmaceutical industry including the cost of the vaccine, and cultural and value differences [28
This study has several limitations including that the method of obtaining the information in one state (Pennsylvania statewide database and interview with the Director of the state’s Immunization Program) was different than how the information was obtained from the other six states (telephone interviews with health department personnel). Although the method in one state was different, the information obtained from this state was complete and there were no outliers. Another limitation was that the person identified as the most knowledgeable about the HPV vaccine at each health department provided estimations of the numbers of HPV vaccine requests, provider recommendation patterns, monthly doses provided, the number of females who have received the vaccine and all three doses of the HPV vaccine. While the numbers are estimations, and are higher than a recent nationwide report of HPV vaccination among adolescents [39
], the key personnel who participated in this study were chosen as respondents because they knew what was happening in their department. In addition, the nationwide report only included adolescents age 13 to 17 for the year 2007 [39
]. Another limitation was the cross-sectional study design which did not allow us to capture changing HPV vaccine policy or availability, although we believe that this would be limited because the study was completed in a relatively short time frame. Some variation among states may be due to differences in the organization of the public health departments in those states and may not be specific to the HPV vaccine. Thus, the findings may not be generalizable to public health departments located in non-Appalachian states, the non-Appalachian regions of the states included in this study, or other Appalachian states.
The strength of this study included the use of a questionnaire designed to obtain HPV vaccine data from the public health departments providing health services to women living in the Appalachian counties of seven states. This allowed us to document important variations about the provision of the HPV vaccine within and among states, which is important because of the significant burden from cervical cancer among women living in this region of the United States.
Findings from this study suggest that there is variation within and among public health departments located within Appalachian states regarding HPV vaccine policy, availability, recommendations, costs, financial assistance, and educational materials. This study highlights the many challenges to deliver new scientific advancements in the prevention of cancer in a user-friendly format to underserved populations, especially rural populations. The differences within and among states found in this study also highlight the need for more consistent policies that maximize accessibility of the HPV vaccine to women, especially those living in underserved areas.