Study Results
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View full resultsBasic Information
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COMPLETED
NA
1227 participants
INTERVENTIONAL
2019-10-03
2022-03-31
Brief Summary
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Detailed Description
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I. Determine the efficacy of the Outsmart HPV intervention on increasing HPV vaccine initiation and completion.
II. Identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion.
III. Determine if intervention efficacy differs across key demographic and health-related characteristics of participants.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP A: Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
GROUP B: Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
GROUP C: Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Participants in all study group are followed for 9 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group A (standard HPV information)
Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Best Practice
Receive standard information about HPV and HPV vaccine
Questionnaire Administration
Ancillary studies
Group B (Outsmart HPV, unidirectional vaccine reminders)
Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Informational Intervention
Receive Outsmart HPV intervention
Questionnaire Administration
Ancillary studies
Text Message-Based Intervention
Receive unidirectional text message vaccine reminders
Group C (Outsmart HPV, interactive vaccine reminders)
Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Informational Intervention
Receive Outsmart HPV intervention
Questionnaire Administration
Ancillary studies
Text Message-Based Intervention
Receive interactive text message vaccine reminders
Interventions
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Best Practice
Receive standard information about HPV and HPV vaccine
Informational Intervention
Receive Outsmart HPV intervention
Questionnaire Administration
Ancillary studies
Text Message-Based Intervention
Receive unidirectional text message vaccine reminders
Text Message-Based Intervention
Receive interactive text message vaccine reminders
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 18-25
* Sexual minority (reports ever having oral or anal sex with a male or being sexually attracted to males; or identifies as gay, bisexual, or queer)
* Lives in the United States (US)
* Has not received any doses of HPV vaccine
* Did not participate in the pilot study
* Read English
* Able to provide informed consent (inferred by completing the screener survey and consent form)
18 Years
25 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Paul Reiter
Principal Investigator
Principal Investigators
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Paul Reiter, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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Marshall DJ, Gower AL, Katz ML, Bauermeister JA, Shoben AB, Reiter PL. Recruitment of Young Gay, Bisexual, and Other Men Who Have Sex With Men for a Web-Based Human Papillomavirus Vaccination Intervention: Differences in Participant Characteristics and Study Engagement by Recruitment Source in a Randomized Controlled Trial. J Med Internet Res. 2025 Jan 3;27:e64668. doi: 10.2196/64668.
Reiter PL, Gower AL, Kiss DE, Malone MA, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee AL. A Web-Based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 24;9(2):e16294. doi: 10.2196/16294.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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The Jamesline
Other Identifiers
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NCI-2019-01223
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-19028
Identifier Type: -
Identifier Source: org_study_id
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