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Completed

NCT Number: NCT02960100

mHealth Intervention in Increasing HPV Vaccinations in College Students

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.

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Key information

Conditions

Healthy Subject

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Receive standard HPV vaccine information (HPV VIS)

Media Intervention

Other

Receive targeted HPV vaccine narrative-style video

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Receipt of the first dose of HPV vaccine in intervention and control group

    Time frame: Up to 7 months

    Will obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group.

  2. Participant satisfaction scores

    Time frame: Up to 7 months

    Acceptability and feasibility will be established by examining participant satisfaction with study materials.

Other outcomes

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

    Time frame: Up to 7 months

    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.

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

    Time frame: Up to 7 months

    Will examine whether the mHealth HPV vaccine intervention affects changes in potential mediators between intervention group and HPV vaccination compared to the control group.

  3. Student feedback based on satisfaction and usability data assessed by surveys

    Time frame: Up to 7 months

  4. Number of times participant logged in to view the narrative or HPV VIS

    Time frame: Up to 7 months

  5. Number of times participants in the intervention group used the link to make an appointment at the health center

    Time frame: Up to 7 months

  6. Total time spent viewing the narrative-style video or HPV VIS

    Time frame: Up to 7 months

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2016
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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