mHealth Intervention in Increasing HPV Vaccinations in College Students

NCT02960100 | Completed DMC

• 3 other identifiers: OSU-16109NCI-2016-01449P30CA016058
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subject

Keywords

Cancer prevention; HPV; Human papillomavirus vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Receipt of the second and third doses of the HPV vaccine series by intervention and control group

  Up to 7 months

• Changes in potential mediators between intervention or control group and HPV vaccination

  Up to 7 months

• Student feedback based on satisfaction and usability data assessed by surveys

  Up to 7 months

Study Arms (2)

Arm I (mHealth HPV vaccine intervention)

EXPERIMENTAL

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; Other: Survey Administration

Arm II (standard HPV information and HPV VIS)

ACTIVE COMPARATOR

Participants receive standard information with the HPV Vaccine Information Statement via the mobile-friendly website.

Other: Informational Intervention; Other: Survey Administration

Interventions

Informational Intervention OTHER

Receive standard HPV vaccine information (HPV VIS)

Arm II (standard HPV information and HPV VIS)

Media Intervention OTHER

Receive targeted HPV vaccine narrative-style video

Arm I (mHealth HPV vaccine intervention)

Survey Administration OTHER

Ancillary studies

Arm I (mHealth HPV vaccine intervention); Arm II (standard HPV information and HPV VIS)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Mira Katz, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: October 18, 2016
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)