Mobile Health Intervention in Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
- Conditions
- Healthy Subject
- Interventions
- Other: Educational InterventionOther: Survey Administration
- Registration Number
- NCT02835755
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 150
- Self-identifies as gay or bisexual
- Lives in the United States (US)
- Has not received any doses of HPV vaccine
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group II (mHealth HPV vaccine) Educational 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. Group I (Control) Educational Intervention Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal. Group I (Control) Survey Administration Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal. Group II (mHealth HPV vaccine) Survey Administration 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.
- Primary Outcome Measures
Name Time Method Feasibility established by achieving recruitment, retention, and medical record release goals 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 Up to 7 months Evaluated using logistic regression.
Acceptability will be established by examining participant satisfaction with study materials 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 Outcome Measures
Name Time Method 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 Evaluated using analysis of covariance models.
Receipt of second and third doses of HPV vaccine Up to 7 months Evaluated using logistic regression.
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States