Clinical trial NCT02960100: mHealth Intervention in Increasing HPV Vaccinations in College Students
Official title: S.M.A.R.T. (Students Motivating and Acting in Real-Time) eStudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Keywords: Cancer prevention
HPV
Human papillomavirus vaccine
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-09
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of the first dose of HPV vaccine in intervention and control group
timeFrame: Up to 7 months
measure: Participant satisfaction scores
timeFrame: Up to 7 months
Secondary outcomes:
Other outcomes:
measure: Receipt of the second and third doses of the HPV vaccine series by intervention and control group
timeFrame: Up to 7 months
measure: Changes in potential mediators between intervention or control group and HPV vaccination
timeFrame: Up to 7 months
measure: Student feedback based on satisfaction and usability data assessed by surveys
timeFrame: Up to 7 months
measure: Number of times participant logged in to view the narrative or HPV VIS
timeFrame: Up to 7 months
measure: Number of times participants in the intervention group used the link to make an appointment at the health center
timeFrame: Up to 7 months
measure: Total time spent viewing the narrative-style video or HPV VIS
timeFrame: Up to 7 months
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Mira Katz, PhD
role: PRINCIPAL_INVESTIGATOR
References: