This phase III trial studies how well the Outsmart HPV intervention works in increasing HPV vaccine initiation and completion among young individuals who report having a history of same-sex partners, being sexually attracted to males, or identify as gay, bisexual, or queer (i.e., sexual minority males). The Outsmart HPV intervention, which is a population-targeted, individually-tailored mHealth intervention that includes vaccine reminders, may increase HPV vaccine initiation and completion among unvaccinated young sexual minority individuals.
PRIMARY OBJECTIVES: I. Determine the efficacy of the Outsmart HPV intervention on increasing HPV vaccine initiation and completion. II. Identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion. III. Determine if intervention efficacy differs across key demographic and health-related characteristics of participants. OUTLINE: Participants are randomized to 1 of 3 groups. GROUP A: Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website. GROUP B: Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond). GROUP C: Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond). Participants in all study group are followed for 9 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,227
Receive standard information about HPV and HPV vaccine
Receive Outsmart HPV intervention
Ancillary studies
University of Minnesota
Minneapolis, Minnesota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Human Papillomavirus (HPV) Vaccine Initiation and Completion
Number and proportion of participants who initiate and complete the HPV vaccine series during the study period
Time frame: Baseline up to 9 months
Changes in Theoretical Constructs
Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change.
Time frame: Baseline up to 9 months
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys
Time frame: Baseline up to 9 months
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Receive unidirectional text message vaccine reminders
Receive interactive text message vaccine reminders