Designing and evaluating a health belief model (HBM) based intervention to increase intent of human papilloma virus (HPV) vaccination among male youth Purvi Mehta, Ph.D. Manoj Sharma, MBBS, MCHES, Ph.D., FAAHB Rebecca Lee, PhD, RN, PHCNS-BC, CTN-A Supported in part by a research grant from Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp.  The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp.

Introduction Human papilloma virus (HPV) is a common sexually transmitted disease/infection (STD/STI). There are several different strains of HPV, but only 40 are known to cause disease through sexual contact. Of these there are four strains: HPV 6, 11, 16 and 18, which can cause genital warts, intraepithelial neoplasia or lead to cervical cancer. Annually, 6.2 million people are newly diagnosed with HPV and 20 million are currently diagnosed. About 50% of men that are sexually active acquire HPV in their lifetime

HPV Vaccine Gardasil, the first vaccine, was initially approved for use in girls and women from the ages of nine to 25. It serves as prevention for HPV 6, 11, 16 and 18 only. Immunization consists of three shots given over a period of six months. The Food and Drug Administration (FDA) approved Gardasil for boys and men nine to 26 years old in 2009 Less than 1% of males have received this vaccine

Purpose & Design Purpose: The purpose of the study was to develop and evaluate a Health Belief Model (HBM) based intervention to increase vaccination in college men. Perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy were the constructs within the HBM that were utilized. Design: Randomized-controlled educational trial was set up to test the intent of vaccination and actual vaccination between two approaches: HBM based educational approach and knowledge-based educational approach.

Instrument A 37-item survey based on the health belief model (HBM) was developed by the researchers. Face and content validity were established by a panel of six experts (two HBM experts, two target population experts, and two HPV vaccine experts) Internal consistency of subscales was established by Cronbach’s alpha wherein values between 0.70 and 0.90 were obtained. Test retest reliability coefficients were computed in a sample of 30 participants; r values between 0.6-0.8 were obtained. Confirmatory factor analysis was also conducted. Results from the model adjustments gave us a good fit model, with a chi-square value of 49.17 (df = 37, p=.087), CFI=0.952, and a RMSEA=.039.

Population and Sample The target population consisted of males between the ages of 18 and 25 years attending a large Midwestern University. The total enrollment at the University is 41,357, with 8.9% African Americans, 3.0% Asian, and 2.0% Hispanic. Of this total student population, 18,695 are males between the ages of 18 to 25 years which consisted of the total target population. Eligibility requirements for participation were: English speaking males, 18 years to 25 years in age, attending the large Midwestern University, who had not taken the vaccine at the start of the study, and were healthy. Both undergraduate and graduate students were eligible for recruitment. A total sample size of 90 men (Faul, Erdfelder, Lang, & Buchner, 2007) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=3, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1

Intervention Perceived severity and perceived susceptibility: Providing information on negative consequences, sharing statistics, personalizing the risk and seriousness for the participants regarding HPV. Barriers that were addressed: Lack of knowledge, fear of taking the vaccine, fear of side effects, cost of the vaccine, and busy schedules. Perceived benefits: Elaboration and discussion of benefits for prevention of the disease and its sequelae, development of herd immunity, a sense of protection and the right thing to do. Cues to action: Identify ways to remind themselves to take vaccine that included post-it notes, through members from social support, and use of daily planner. Self-efficacy: Nine easy steps: (1) call your insurance to find out it HPV vaccine is covered; (2) if not covered, arrange for $400; (3) call your doctor to schedule appointment for getting HPV vaccine within the next two weeks; (4) go to the first appointment; (5) get the first dose of HPV vaccine; (6) schedule second appointment after 2 months; (7) get the second dose of HPV vaccine; (8) schedule third appointment after 6 months; and (9) get the third dose of HPV vaccine and you are all set.

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Discussion…1 Participants enrolled in this study were primarily single, heterosexual, Caucasian, early college (freshmen/sophomore) level, about 20.6 year old males from a large Midwestern University. Repeated measures ANOVA among the Health Belief Model constructs, and intent to vaccinate showed the experimental group had improved scores over time significantly than the control group. Significance over time was seen with knowledge, as mean scores for both groups increased between pre and post-test but at follow up no significance over time was found

Discussion…2 With regards to awareness of the vaccine at baseline, 97.8% heard of HPV but only 91.1% were aware of the vaccine, while 2.2% had never heard of HPV and 8.9% were unaware of the vaccine. In terms of vaccine acceptability, 37.8% were in favor of intent to vaccinate and 28.9% were strongly in favor towards intent to vaccinate with the experimental group (total 66.7%). At follow up with 10 participants, 11.1% and 4.4% agreed and strongly agreed to vaccinate, respectively. For the control group at post-test, 28.9% and 15.6% agreed or strongly agreed towards vaccine acceptability, respectively (total 44.5%), while only 2.2% at a follow up of six, had the intent to vaccinate.

Limitations Attrition at follow up Only students from one large Midwestern University were recruited Most of the participants were Caucasian, heterosexual males Differences were present between groups from the beginning of the study: ANCOVA was done to compensate for some of that

Implications for Practice Increasing knowledge and awareness of HPV affecting men is crucial in promoting the HPV vaccine. Hesitations remain in the actual behavior of taking the vaccine. This is due to barriers and lack of information regarding HPV and the vaccine. Health belief model served as a useful framework to design the educational programs. Utilizing HBM to help overcome barriers while building self-efficacy and benefits in HPV vaccination were behavioral enablers towards taking the vaccine. Intervention was brief, a two hour session which covered all health belief model constructs was both practical and useful.