This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV) vaccine intervention works in increasing HPV vaccine coverage among young adult gay and bisexual men. Giving young men information about the HPV vaccine and the importance of vaccination may encourage them to get the HPV vaccine.
PRIMARY OBJECTIVES: I. Pilot test a mobile health (mHealth) HPV vaccine intervention for young gay and bisexual men to establish feasibility and acceptability. II. Obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group. SECONDARY OBJECTIVES: I. Examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared to the control group. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (CONTROL): Patients receive standard information about HPV and HPV vaccine, such as the vaccine information statement (VIS), on a mobile-friendly website study portal. GROUP II (INTERVENTION): Patients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail. All patients complete a survey on the study portal at baseline, immediately after the mHealth intervention or control materials, and at 3 months and 7 months thereafter for about 10-15 minutes each.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Receive standard HPV and HPV vaccine information
Receive mHealth HPV vaccine intervention
Ancillary studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Acceptability will be established by examining participant satisfaction with study materials
Linear regression will be used and usage data and satisfaction with vaccination reminders (intervention group only) will be descriptively examined.
Time frame: Up to 7 months
Feasibility established by achieving recruitment, retention, and medical record release goals
Critical parameters with point estimates and 95% confidence intervals will be estimated and tested with a two-sided alpha=.05
Time frame: Up to 7 months
Receipt of 1 or more doses of HPV vaccine
Evaluated using logistic regression.
Time frame: Up to 7 months
Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge)
Evaluated using analysis of covariance models.
Time frame: Up to 7 months
Receipt of second and third doses of HPV vaccine
Evaluated using logistic regression.
Time frame: Up to 7 months
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