mHealth Intervention in Increasing HPV Vaccinations in College Students

Healthy Subject Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960100
• Other study ID #: OSU-16109
• Secondary ID: NCI-2016-01449P3
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: February 19, 2018
• Start date: October 18, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: February 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Other:
• Informational Intervention
Receive standard HPV vaccine information (HPV VIS)
• Media Intervention
Receive targeted HPV vaccine narrative-style video
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Student feedback based on satisfaction and usability data assessed by surveys		Up to 7 months
Other	Number of times participant logged in to view the narrative or HPV VIS		Up to 7 months
Other	Number of times participants in the intervention group used the link to make an appointment at the health center		Up to 7 months
Other	Total time spent viewing the narrative-style video or HPV VIS		Up to 7 months
Primary	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
Primary	Participant satisfaction scores	Acceptability and feasibility will be established by examining participant satisfaction with study materials.	Up to 7 months