Elsevier

Vaccine

Volume 29, Issue 3, 10 January 2011, Pages 570-576
Vaccine

Should I or Shouldn’t I: Decision making, knowledge and behavioral effects of quadrivalent HPV vaccination in men who have sex with men

https://doi.org/10.1016/j.vaccine.2010.09.101Get rights and content

Abstract

Prior to FDA licensure in men, a surgical practice (SG) offered the quadrivalent HPV vaccine (qHPV) off-label to men who have sex with men (MSM). We administered a written or telephone survey to MSM to elicit drivers and barriers to vaccination, sexual behavior changes post-vaccination, and knowledge. 191 subjects enrolled: 68 refused qHPV, 71 received qHPV <1 year ago, and 52 received qHPV >1 year ago. History of HPV infection (86%, n = 164) and level of HPV and qHPV knowledge were high, with a mean of 10.8 of 13 knowledge questions correct. Ninety-seven percent of participants understood that qHPV does not cure present infection or disease. MSM refused qHPV for reasons including cost and not FDA approved; prevention of future HPV infection was the paramount driver for immunization. Vaccination did not affect sexual behavior.

Introduction

Human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States, with persistent infection causing significant morbidity, including genital warts, cervical, vulvar and vaginal cancer, and up to 93% of anal cancers [1]. HPV infection has become partially preventable in men with the development of Gardasil® (Merck & Co., Inc., Whitehouse Station, NJ, USA), a quadrivalent prophylactic HPV 6/11/16/18 virus-like particle vaccine. In June 2006, Gardasil® (qHPV) was FDA approved for women ages nine through 26 years for prevention of HPV types 6-, 11-, 16-, and 18-related cervical, vaginal, and vulvar cancer and precursor dysplastic lesions as well as genital warts [2]. In October 2009, this approval was extended to men ages nine through 26 years for prevention of HPV-related external genital lesions [3].

The incidence of new HPV infections is estimated at 6.2 million per year [4]. The Center for Disease Control and Prevention's (CDC) National Health and Nutrition Examination Survey 2003–2004 (NHANES) reported that 12.2% of male participants were infected with HPV type 6, 11, 16 or 18, and 6.3% of men had oncogenic HPV types 16 or 18, as measured by serum antibodies [5]. A study of 290 men in Arizona in 2005 revealed that 30.0% were infected with one of 37 tested HPV types, detected by PCR of genital swabs. The period prevalence of HPV infection in this study was 52.8% [6]. Genital warts, or condyloma acuminata, caused primarily by HPV 6 and 11, have an estimated lifetime cumulative prevalence of 4.9% and annual prevalence of 0.17–0.21% [5], [7]. Furthermore, the rate of HPV-associated invasive squamous cell anal carcinoma has risen in recent years [1]. While HPV is prevalent in all men, men who have sex with men (MSM) have higher rates of infection than heterosexual men. Among a sample of heterosexual men in Florida in 2007, 12.0% had anal HPV infection with any of 37 types, and 7.0% had oncogenic HPV infection [8]. In a large study of HIV-negative MSM, 57% had anal HPV infection with any of 22 tested HPV types, 26% of which were oncogenic [9]. MSM are at greater risk for HPV due to anal intercourse, which has been identified as an independently associated risk factor for HPV infection [5], [8], [10].

Administration of qHPV to women ages 24–45 years demonstrated 83% efficacy in protecting against HPV 16/18 infection or disease [11]. Studies in young men ages 16–26 years showed qHPV to be 90.4% effective against HPV 6/11/16/18-related external genital lesions and 85.6% effective against persistent HPV 6/11/16/18 infection [12]. The vaccine was not studied in older men. In acceptability studies, at least half of adult women and 74% of MSM claimed they would receive HPV vaccination [13], [14]. Another study of Australian MSM ages 19–71 years reported that nearly 50% of participants would pay Au$450 out of pocket for HPV vaccination [15].

Despite evidence that qHPV is effective and studies indicate that patients are willing to accept it, vaccination rates remain low. In 2008, 37.2% of adolescent females had begun the vaccination series (≥1 dose), while 17.9% had completed the series [16]. Barriers to vaccination in young women ages 9–26 years include not being sexually active, concern about vaccine safety, and cost [17]. Barriers to vaccination in adult women include cost, limited knowledge about HPV, and perception of a low risk for HPV infection or cervical cancer [13]. There is no published data to date examining qHPV vaccination rates in men.

In this pilot study, we sought to elicit reasons motivating MSM to either choose or refuse qHPV vaccination, effects of vaccination on subsequent sexual behavior as well as basic knowledge about HPV and vaccination in MSM offered qHPV.

Section snippets

Study population and procedure

Subjects were recruited between June 2009 and September 2009 from a surgical practice (SG) at which men and women are screened and treated for HPV-related anorectal disease. Off-label use of qHPV was first offered at this site in January 2007 for HIV-negative men up to age 55 years. Medical records were reviewed to identify MSM who either accepted or refused vaccination when offered. To be eligible, those that received qHPV had to have completed all three doses before entry. Subjects were

Results

191 MSM enrolled: 68 refused qHPV vaccination (RV), 71 were vaccinated with qHPV less than one year prior (V < 1), and 52 were vaccinated greater than one year prior (V > 1) (Table 1). Surveys were primarily conducted by telephone (overall 58%, n = 111; RV = 37%, n = 25; V < 1 = 61%, n = 43; V > 1 = 83%, n = 43).

Discussion

QHPV vaccination for HPV 6/11/16/18 was recently FDA approved for young men ages 9–26 years to prevent HPV related external genital lesions. Although not studied, it may also be beneficial for MSM older than 26 years. This pilot study is the first to compare MSM who have actually been offered and either refused or accepted qHPV vaccination to determine knowledge of HPV and vaccination, factors influencing decision making, and to ascertain possible effects on sexual behavior.

Conclusion

MSM exhibit a high level of knowledge about HPV and HPV vaccination. They received qHPV to prevent future disease, but understood that the vaccine may not prevent all future disease and will not cure ongoing disease. Vaccination did not affect frequency of anal sex or unprotected anal sex. Cost, lack of knowledge about the vaccine, and a feeling that they were already infected were major barriers to vaccination, while a desire to prevent future infection was a major driver to vaccination.

Acknowledgements

We thank Erin Moshier and Kristin Swedish for statistical analysis and Doug Marks and Nadia Scott for help with survey administration. Funding for this project was a summer stipend from the Mount Sinai School of Medicine.

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