mHealth Intervention in Increasing HPV Vaccinations in College Students

Study Overview
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Brief Summary
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This randomized pilot trial studies how well a mobile health (mHealth) intervention works in increasing human papillomavirus (HPV) vaccination among college students at the Ohio State University. mHealth educational intervention may communicate information about HPV vaccination and increase HPV vaccine uptake in college students.

Detailed Description
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PRIMARY OBJECTIVES: I. Pilot test an mHealth HPV vaccine intervention for college students 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: Participants are randomized to 1 of 2 arms. ARM I: Participants receive targeted HPV vaccine narrative-style video via the mobile-friendly website. Participants also receive monthly HPV vaccination reminders via email or by text message. ARM II: Participants receive standard information about HPV and then HPV vaccine information statement (VIS) via the mobile-friendly website. After completion of study, participants are followed up at 3 and 7 months.

Official Title
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S.M.A.R.T. (Students Motivating and Acting in Real-Time) eStudy

Conditions
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Healthy Subject

Intervention / Treatment
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* Other: Informational Intervention
* Other: Media Intervention
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently enrolled as a first year Ohio State University (OSU) student on the Columbus campus Being able to read English Not having received any doses of the HPV vaccine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (mHealth HPV vaccine intervention)<br>Participants receive targeted HPV vaccine narrative-style video via the mobile-friendly website. Participants also receive monthly HPV vaccination reminders via email or by text message. | Other: Media Intervention<br>* Receive targeted HPV vaccine narrative-style video<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (standard HPV information and HPV VIS)<br>Participants receive standard information with the HPV Vaccine Information Statement via the mobile-friendly website. | Other: Informational Intervention<br>* Receive standard HPV vaccine information (HPV VIS)<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of the first dose of HPV vaccine in intervention and control group | Will obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group. | Up to 7 months | 
| Participant satisfaction scores | Acceptability and feasibility will be established by examining participant satisfaction with study materials. | Up to 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Cancer prevention, Human papillomavirus vaccine