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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00819 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA016058 | U.S. NIH Grant/Contract | View source | |
| R21CA194831 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV) vaccine intervention works in increasing HPV vaccine coverage among young adult gay and bisexual men. Giving young men information about the HPV vaccine and the importance of vaccination may encourage them to get the HPV vaccine.
PRIMARY OBJECTIVES:
I. Pilot test a mobile health (mHealth) HPV vaccine intervention for young gay and bisexual men 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: Patients are randomized to 1 of 2 groups.
GROUP I (CONTROL): Patients receive standard information about HPV and HPV vaccine, such as the vaccine information statement (VIS), on a mobile-friendly website study portal.
GROUP II (INTERVENTION): Patients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail.
All patients complete a survey on the study portal at baseline, immediately after the mHealth intervention or control materials, and at 3 months and 7 months thereafter for about 10-15 minutes each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Control) | Active Comparator | Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal. |
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| Group II (mHealth HPV vaccine) | Experimental | Patients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive standard HPV and HPV vaccine information |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability will be established by examining participant satisfaction with study materials | Linear regression will be used and usage data and satisfaction with vaccination reminders (intervention group only) will be descriptively examined. | Up to 7 months |
| Feasibility established by achieving recruitment, retention, and medical record release goals | Critical parameters with point estimates and 95% confidence intervals will be estimated and tested with a two-sided alpha=.05 | Up to 7 months |
| Receipt of 1 or more doses of HPV vaccine | Evaluated using logistic regression. | Up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge) | Evaluated using analysis of covariance models. | Up to 7 months |
| Receipt of second and third doses of HPV vaccine |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Reiter, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29979642 | Derived | Reiter PL, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee AL. Increasing Human Papillomavirus Vaccination Among Young Gay and Bisexual Men: A Randomized Pilot Trial of the Outsmart HPV Intervention. LGBT Health. 2018 Jul;5(5):325-329. doi: 10.1089/lgbt.2018.0059. | |
| 29331245 | Derived | McRee AL, Shoben A, Bauermeister JA, Katz ML, Paskett ED, Reiter PL. Outsmart HPV: Acceptability and short-term effects of a web-based HPV vaccination intervention for young adult gay and bisexual men. Vaccine. 2018 Dec 18;36(52):8158-8164. doi: 10.1016/j.vaccine.2018.01.009. Epub 2018 Jan 10. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Educational Intervention | Other | Receive mHealth HPV vaccine intervention |
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| Survey Administration | Other | Ancillary studies |
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Evaluated using logistic regression. |
| Up to 7 months |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |