Annie-Laurie McRee, Ph.D. - US grants

? DESCRIPTION (provided by applicant): Human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (US), and infections can cause a range of adverse health outcomes among females, including several types of cancer (e.g., cervical cancer) and anogenital warts. Women are at risk for HPV infection regardless of their sexual orientation since HPV can be transmitted between female sexual partners, and many sexual minority women (i.e., women with a history of sex with women or who identify as non-heterosexual) have current or past male sexual partners from whom they could have acquired HPV. Our long-term goal is to develop and test an HPV and cervical cancer prevention intervention for sexual minority women, and our preliminary research shows that a preferred intervention component is targeted information about the prevalence HPV infection among sexual minority women. However, epidemiological data on HPV infection (genital and oral) among this population are currently lacking. Further, to date, no research has examined how the prevalence of HPV infection may differ across dimensions of sexual orientation, including sexual behavior (i.e., having sex with male or female partners) and sexual identity (i.e., considering oneself lesbian, bisexual, etc.). Such differences will have important implications for communicating information in our future intervention. We propose to address the existing research gaps by conducting secondary analyses of laboratory-verified HPV infection data among a population-based sample from the 2003-2012 National Health and Nutrition Examination Survey (NHANES). The proposed study, HPV Infection among Sexual Minority Women in the United States, will be the most comprehensive examination to date on HPV infection among sexual minority women, a hard-to-reach and understudied population at risk for health disparities. Aim 1 will provide robust data on the prevalence of genital HPV infection and differences across two dimensions of sexual orientation (i.e., sexual behavior and sexual identity). Such data are critical to women's knowledge about and perceived risk of HPV, which can in turn affect health behaviors. Aim 2 will identify determinants of genital HPV infection among sexual minority women, which will be key to our future intervention by identifying subgroups of sexual minority women at particularly high risk of HPV infection. Aim 3 will provide novel data on the prevalence of oral HPV infection among sexual minority women, which is important given the link between oral HPV infection and oral sex. Results from this study will provide needed robust data on HPV infection among sexual minority women, which will be a critical component of our future HPV and cervical cancer prevention intervention for this population.

? DESCRIPTION (provided by applicant): Gay and bisexual men have high rates of human papillomavirus (HPV) infection and HPV-related disease (e.g., anal cancer) compared to the general population. HPV vaccination is a promising strategy for reducing these existing disparities, as routine HPV vaccination is recommended for young gay and bisexual men (YGBM) through age 26. However, little research has addressed HPV vaccination among YGBM, and no interventions we are aware of have been developed specifically for this high-risk population. To address this important research gap, we conducted a national survey of YGBM ages 18-26 in late 2013. Only about 13% of participants had received any doses of HPV vaccine, and results provided valuable information for designing an HPV vaccine intervention for YGBM. Based on results of this preliminary research, an interdisciplinary research team will conduct the proposed study, Increasing HPV Vaccine Coverage among Young Adult Gay and Bisexual Men. The study will develop and pilot test a theoretically-based mobile health (mHealth) HPV vaccine intervention for YGBM that will consist of: 1) population-targeted, individually-tailored content about HPV and HPV vaccine; and 2) vaccination reminders. During pilot testing, the intervention will be compared to a control group that receives standard information about HPV and HPV vaccine via a mobile-friendly website. The study will have two primary aims and an exploratory aim. Aim 1 will develop and pilot test the mHealth HPV vaccine intervention for YGBM to establish intervention feasibility and acceptability. Feasibility will be established by meeting recruitment (n=94) and retention (85% retention over a 6-month follow-up period) goals for the pilot study, and acceptability will be established by comparing participant satisfaction with study materials between the intervention and control groups. Aim 2 will obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group. HPV vaccine initiation (i.e., receipt of the first dose of the three-dose HPV vaccine series) will serve as the primary outcome for the pilot study. An exploratory aim will examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared to the control group. Secondary outcomes will include receipt of the second and third doses of the HPV vaccine series and changes in potential mediators between study group and HPV vaccination. Results from the pilot study will establish intervention feasibility and acceptability and provide valuable preliminary data on outcomes related to HPV vaccination. These data will inform an R01 grant application to test the efficacy of the mHealth HPV vaccine intervention in a large randomized controlled trial.

PROJECT SUMMARY Our overall goal is to increase human papillomavirus (HPV) vaccination among young sexual minority men (YSMM). Sexual minority men (i.e., men who have sex with men or identify as gay or bisexual) have high rates of HPV infection and HPV-related disease, including anal cancer. HPV vaccine is recommended for sexual minority men through age 26, yet fewer than 21% of YSMM ages 18-26 have received any HPV vaccine doses (i.e., initiation) and fewer than 10% have received all three recommended doses (i.e., completion). To address this issue, we recently developed and pilot tested a theoretically-informed mobile health HPV vaccine intervention for YSMM (Outsmart HPV). To our knowledge, Outsmart HPV is the first HPV vaccine intervention developed for this population. The pilot study established the intervention?s feasibility and acceptability and produced very promising preliminary data. However, the pilot nature of this study precluded us from formally establishing intervention efficacy or examining additional intervention mechanism processes. The proposed study is a critical next step in this line of research because it will build upon our pilot study to comprehensively evaluate Outsmart HPV via a well-powered randomized controlled trial. We will recruit 1995 unvaccinated YSMM ages 18-25 from the US via social media and randomize each participant to either: a) standard information about HPV and HPV vaccine via a mobile-friendly website (control group); b) Outsmart HPV with unidirectional vaccine reminders; or c) Outsmart HPV with interactive vaccine reminders. Aim 1 will determine the efficacy of Outsmart HPV on increasing HPV vaccine initiation and completion. In doing so, the aim will determine which type of HPV vaccine reminders (unidirectional or interactive) most effectively increases vaccination as part of the Outsmart HPV intervention. Aim 2 will identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion. This will identify the mechanism by which the intervention affects HPV vaccination (i.e., how the intervention leads to changes in theoretical constructs which in turn lead to vaccination). Aim 3 will determine if intervention efficacy differs across key demographic and health-related characteristics of participants (i.e., moderation). This will allow us to determine if Outsmart HPV has differential efficacy across subgroups and, if so, to identify those men for whom the intervention may require further adaptation in the future. Results of the proposed study will provide an evidence base regarding intervention efficacy, mediators, and moderators. These findings will offer a sophisticated understanding of Outsmart HPV that is needed to effectively and efficiently disseminate this innovative intervention to YSMM in the future.