Mobile Health Intervention in Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men

Conditions
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Healthy Subject

Intervention / Treatment
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* Other: Educational Intervention
* Other: Educational Intervention
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identifies as gay or bisexual Lives in the United States (US) Has not received any doses of HPV vaccine

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (Control)<br>Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal. | Other: Educational Intervention<br>* Receive standard HPV and HPV vaccine information<br>* Other names: Intervention, Educational;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Group II (mHealth HPV vaccine)<br>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. | Other: Educational Intervention<br>* Receive mHealth HPV vaccine intervention<br>* Other names: Intervention, Educational;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Evaluated using logistic regression. | Up to 7 months |