Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Feasibility established by achieving recruitment, retention, and medical record release goals
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-identifies as gay or bisexual
- •Lives in the United States (US)
- •Has not received any doses of HPV vaccine
排除标准
- 未提供
研究组 & 干预措施
Group I (Control)
Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal.
干预措施: Educational Intervention (Other)
Group I (Control)
Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal.
干预措施: Survey Administration (Other)
Group II (mHealth HPV vaccine)
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.
干预措施: Educational Intervention (Other)
Group II (mHealth HPV vaccine)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Feasibility established by achieving recruitment, retention, and medical record release goals
时间窗: 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
时间窗: Up to 7 months
Evaluated using logistic regression.
Acceptability will be established by examining participant satisfaction with study materials
时间窗: Up to 7 months
Linear regression will be used and usage data and satisfaction with vaccination reminders (intervention group only) will be descriptively examined.
次要结局
- 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)
研究者
Paul Reiter
Principal Investigator
Ohio State University Comprehensive Cancer Center