Healthy Subject
Conditions
Keywords
HPV, Men, Vaccine
Brief summary
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.
Detailed description
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.
Interventions
OTHERBest Practice
Receive standard information about HPV and HPV vaccine
OTHERInformational Intervention
Receive Outsmart HPV intervention
OTHERQuestionnaire Administration
Ancillary studies
BEHAVIORALText Message-Based Intervention
Receive unidirectional text message vaccine reminders
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants are not aware of the research questions being tested in the trial.
Eligibility
Sex/Gender
MALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Cisgender male * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Papillomavirus (HPV) Vaccine Initiation and Completion | Baseline up to 9 months | Number and proportion of participants who initiate and complete the HPV vaccine series during the study period |
| Changes in Theoretical Constructs | Baseline up to 9 months | 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. |
| Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Baseline up to 9 months | Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 412 |
| 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 | 407 |
| 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 | 408 |
| Total | 1,227 |
Baseline characteristics
| Characteristic | Total | Group A (Standard HPV Information) | Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Group C (Outsmart HPV, Interactive Vaccine Reminders) |
|---|---|---|---|---|
| Age, Customized Ages 18-21 | 437 Participants | 142 Participants | 152 Participants | 143 Participants |
| Age, Customized Ages 22-25 | 790 Participants | 270 Participants | 255 Participants | 265 Participants |
| Race/Ethnicity, Customized Hispanic | 352 Participants | 130 Participants | 112 Participants | 110 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 129 Participants | 37 Participants | 45 Participants | 47 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 167 Participants | 57 Participants | 52 Participants | 58 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 579 Participants | 188 Participants | 198 Participants | 193 Participants |
| Region of Enrollment United States | 1227 Participants | 412 Participants | 407 Participants | 408 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1227 Participants | 412 Participants | 407 Participants | 408 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 412 | 0 / 407 | 0 / 408 |
| other Total, other adverse events | 0 / 412 | 0 / 407 | 0 / 408 |
| serious Total, serious adverse events | 0 / 412 | 0 / 407 | 0 / 408 |
Outcome results
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.
Time frame: Baseline up to 9 months
Population: Participants who completed the end-of-study survey at 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Standard HPV Information) | Changes in Theoretical Constructs | Response efficacy of HPV vaccine | 0.41 Scores on a scale | Standard Deviation 0.84 |
| Group A (Standard HPV Information) | Changes in Theoretical Constructs | Perceived severity of HPV-related disease | -0.04 Scores on a scale | Standard Deviation 0.74 |
| Group A (Standard HPV Information) | Changes in Theoretical Constructs | Worry about getting HPV-related disease | 0.63 Scores on a scale | Standard Deviation 0.98 |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Changes in Theoretical Constructs | Response efficacy of HPV vaccine | 0.58 Scores on a scale | Standard Deviation 0.88 |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Changes in Theoretical Constructs | Perceived severity of HPV-related disease | 0.01 Scores on a scale | Standard Deviation 0.79 |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Changes in Theoretical Constructs | Worry about getting HPV-related disease | 0.56 Scores on a scale | Standard Deviation 1.05 |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Changes in Theoretical Constructs | Perceived severity of HPV-related disease | -0.09 Scores on a scale | Standard Deviation 0.75 |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Changes in Theoretical Constructs | Worry about getting HPV-related disease | 0.57 Scores on a scale | Standard Deviation 0.98 |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Changes in Theoretical Constructs | Response efficacy of HPV vaccine | 0.50 Scores on a scale | Standard Deviation 0.85 |
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
Time frame: Baseline up to 9 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A (Standard HPV Information) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Ages 18-21 | 41 Participants |
| Group A (Standard HPV Information) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Ages 22-25 | 73 Participants |
| Group A (Standard HPV Information) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | High school education or less | 33 Participants |
| Group A (Standard HPV Information) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Some college education or more | 81 Participants |
| Group A (Standard HPV Information) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Preventive health visit within the last year | 56 Participants |
| Group A (Standard HPV Information) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | No preventive health visit within the last year | 58 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | No preventive health visit within the last year | 74 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Ages 18-21 | 53 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Some college education or more | 95 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Preventive health visit within the last year | 65 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Ages 22-25 | 86 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | High school education or less | 44 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Ages 22-25 | 101 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | High school education or less | 39 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | No preventive health visit within the last year | 81 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Some college education or more | 108 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Ages 18-21 | 46 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics | Preventive health visit within the last year | 66 Participants |
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
Time frame: Baseline up to 9 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A (Standard HPV Information) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Initiation | No | 298 Participants |
| Group A (Standard HPV Information) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Completion | Yes | 14 Participants |
| Group A (Standard HPV Information) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Initiation | Yes | 114 Participants |
| Group A (Standard HPV Information) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Completion | No | 398 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Initiation | No | 268 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Completion | No | 377 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Completion | Yes | 30 Participants |
| Group B (Outsmart HPV, Unidirectional Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Initiation | Yes | 139 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Completion | No | 361 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Initiation | Yes | 147 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Initiation | No | 261 Participants |
| Group C (Outsmart HPV, Interactive Vaccine Reminders) | Human Papillomavirus (HPV) Vaccine Initiation and Completion | HPV Vaccine Series Completion | Yes | 47 Participants |