An interventional study of Educational Intervention and Educational Intervention in Healthy Subject, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-03.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal.
Other: Educational Intervention · Other: Survey Administration
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.
Other: Educational Intervention · Other: Survey Administration
Receive standard HPV and HPV vaccine information
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive mHealth HPV vaccine intervention
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
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
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center