A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,227
- 试验地点
- 4
- 主要终点
- Human Papillomavirus (HPV) Vaccine Initiation and Completion
研究概览
简要总结
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.
详细描述
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.
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
- Single (Participant)
盲法说明
Participants are not aware of the research questions being tested in the trial.
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
- •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)
排除标准
- 未提供
结局指标
主要结局
Human Papillomavirus (HPV) Vaccine Initiation and Completion
时间窗: Baseline up to 9 months
Number and proportion of participants who initiate and complete the HPV vaccine series during the study period
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
时间窗: Baseline up to 9 months
Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys
Changes in Theoretical Constructs
时间窗: Baseline up to 9 months
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.
次要结局
未报告次要终点
研究者
Paul Reiter
Principal Investigator
Ohio State University Comprehensive Cancer Center