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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01449 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA016058 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive standard HPV vaccine information (HPV VIS) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in potential mediators between intervention or control group and HPV vaccination |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mira Katz, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Media Intervention | Other | Receive targeted HPV vaccine narrative-style video |
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| Survey Administration | Other | Ancillary studies |
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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 |
| Student feedback based on satisfaction and usability data assessed by surveys | Up to 7 months |
| Number of times participant logged in to view the narrative or HPV VIS | Up to 7 months |
| Number of times participants in the intervention group used the link to make an appointment at the health center | Up to 7 months |
| Total time spent viewing the narrative-style video or HPV VIS | Up to 7 months |