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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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