HPV Vaccine Intervention for Young Sexual Minority Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men

Conditions
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Healthy Subject

Intervention / Treatment
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* Other: Best Practice
* Other: Informational Intervention
* Other: Questionnaire Administration
* Behavioral: Text Message-Based Intervention
* Behavioral: Text Message-Based Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (standard HPV information)<br>Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website. | Other: Best Practice<br>* Receive standard information about HPV and HPV vaccine<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group B (Outsmart HPV, unidirectional vaccine reminders)<br>Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond). | Other: Informational Intervention<br>* Receive Outsmart HPV intervention<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Text Message-Based Intervention<br>* Receive unidirectional text message vaccine reminders<br>|
| Experimental: Group C (Outsmart HPV, interactive vaccine reminders)<br>Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond). | Other: Informational Intervention<br>* Receive Outsmart HPV intervention<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Text Message-Based Intervention<br>* Receive interactive text message vaccine reminders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Men, Vaccine