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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01223 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R37CA226682 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase III trial studies how well the Outsmart HPV intervention works in increasing HPV vaccine initiation and completion among young individuals who report having a history of same-sex partners, being sexually attracted to males, or identify as gay, bisexual, or queer (i.e., sexual minority males). The Outsmart HPV intervention, which is a population-targeted, individually-tailored mHealth intervention that includes vaccine reminders, may increase HPV vaccine initiation and completion among unvaccinated young sexual minority individuals.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (standard HPV information) | Active Comparator | Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website. |
|
| Group B (Outsmart HPV, unidirectional vaccine reminders) | Experimental | Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond). |
|
| Group C (Outsmart HPV, interactive vaccine reminders) | Experimental | Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard information about HPV and HPV vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Human Papillomavirus (HPV) Vaccine Initiation and Completion | Number and proportion of participants who initiate and complete the HPV vaccine series during the study period | Baseline up to 9 months |
| Changes in Theoretical Constructs | Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change. | Baseline up to 9 months |
| Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys | Baseline up to 9 months |
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Inclusion Criteria:
Cisgender male
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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 |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Ohio State University Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39752644 | Derived | 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. | |
| 32130192 | Derived | 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. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group B (Outsmart HPV, Unidirectional Vaccine Reminders) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Human Papillomavirus (HPV) Vaccine Initiation and Completion | Number and proportion of participants who initiate and complete the HPV vaccine series during the study period | Posted | Count of Participants | Participants | Baseline up to 9 months |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Reiter | Ohio State University | 614-292-4803 | reiter.36@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2021 | Feb 20, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2019 | Feb 20, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Participants are not aware of the research questions being tested in the trial.
| Informational Intervention | Other | Receive Outsmart HPV intervention |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Text Message-Based Intervention | Behavioral | Receive unidirectional text message vaccine reminders |
|
| Text Message-Based Intervention | Behavioral | Receive interactive text message vaccine reminders |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| Primary | Changes in Theoretical Constructs | Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change. | Participants who completed the end-of-study survey at 9 months | Posted | Mean | Standard Deviation | Scores on a scale | Baseline up to 9 months |
|
|
|
| Primary | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys | Posted | Count of Participants | Participants | No | Baseline up to 9 months |
|
|
|
| 0 |
| 412 |
| 0 |
| 412 |
| 0 |
| 412 |
| EG001 | 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 | 0 | 407 | 0 | 407 | 0 | 407 |
| EG002 | 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 | 0 | 408 | 0 | 408 | 0 | 408 |
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| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
|
| Worry about getting HPV-related disease |
|
| Title | Measurements |
|---|---|
|
| High school education or less |
|
| Some college education or more |
|
| Preventive health visit within the last year |
|
| No preventive health visit within the last year |
|