Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Subject
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Feasibility established by achieving recruitment, retention, and medical record release goals
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Paul Reiter
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Inclusion Criteria
- •Self-identifies as gay or bisexual
- •Lives in the United States (US)
- •Has not received any doses of HPV vaccine
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility established by achieving recruitment, retention, and medical record release goals
Time Frame: Up to 7 months
Critical parameters with point estimates and 95% confidence intervals will be estimated and tested with a two-sided alpha=.05
Receipt of 1 or more doses of HPV vaccine
Time Frame: Up to 7 months
Evaluated using logistic regression.
Acceptability will be established by examining participant satisfaction with study materials
Time Frame: Up to 7 months
Linear regression will be used and usage data and satisfaction with vaccination reminders (intervention group only) will be descriptively examined.
Secondary Outcomes
- Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge)(Up to 7 months)
- Receipt of second and third doses of HPV vaccine(Up to 7 months)