mHealth Intervention in Increasing HPV Vaccinations in College Students

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Other: Survey Administration; Other: Media Intervention; Other: Informational Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (mHealth HPV vaccine intervention); 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: Survey Administration; Ancillary studies; Other: Media Intervention; Receive targeted HPV vaccine narrative-style video
Active Comparator: Arm II (standard HPV information and HPV VIS); Participants receive standard information with the HPV Vaccine Information Statement via the mobile-friendly website.	Other: Survey Administration; Ancillary studies; Other: Informational Intervention; Receive standard HPV vaccine information (HPV VIS)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of the second and third doses of the HPV vaccine series by intervention and control group	Will examine whether the mHealth HPV vaccine intervention affects the receipt of the second and third doses of the HPV vaccine series compared to the control group.	Up to 7 months
Changes in potential mediators between intervention or control group and HPV vaccination	Will examine whether the mHealth HPV vaccine intervention affects changes in potential mediators between intervention group and HPV vaccination compared to the control group.	Up to 7 months
Student feedback based on satisfaction and usability data assessed by surveys		Up to 7 months
Number of times participant logged in to view the narrative or HPV VIS		Up to 7 months
Number of times participants in the intervention group used the link to make an appointment at the health center		Up to 7 months
Total time spent viewing the narrative-style video or HPV VIS		Up to 7 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mira Katz, PhD, Ohio State University Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: HPV; Cancer prevention; Human papillomavirus vaccine
• Other Study ID Numbers: OSU-16109; P30CA016058 (U.S. NIH Grant/Contract); NCI-2016-01449 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO