mHealth Intervention in Increasing HPV Vaccinations in College Students

NCT ID: NCT02960100

Last Updated: 2018-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-18

Study Completion Date

2017-08-31

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.

Conditions

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Healthy Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Media Intervention

Intervention Type OTHER

Receive targeted HPV vaccine narrative-style video

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (standard HPV information and HPV VIS)

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

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive standard HPV vaccine information (HPV VIS)

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Informational Intervention

Receive standard HPV vaccine information (HPV VIS)

Intervention Type OTHER

Media Intervention

Receive targeted HPV vaccine narrative-style video

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Mira Katz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mira Katz, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2016-01449

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA016058

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-16109

Identifier Type: -

Identifier Source: org_study_id

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