Advancing New Computer-based Health Outcomes Regarding Sexual Behavior(ANCHORS) Study: UH2 Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 673
- 试验地点
- 2
- 主要终点
- High-risk Sexual Behavior: Condomless Sex
研究概览
简要总结
According to the National HIV/AIDS Strategy, men who have sex with men (MSM), young adults, Black and Latino men and people in the Southern U.S. are at highest HIV risk and should be targeted with cost-effective, scalable interventions. The study team propose a synergistic mobile intervention to reduce alcohol and HIV risk in young adult MSM that combines 3 efficacious approaches.
详细描述
New prevention efforts must address alcohol and HIV and be directed to the highest-risk groups. While interventions have targeted MSM, few have targeted young MSM specifically. Young people and MSM bring particular challenges. Thus, it is important that prevention be targeted to them and developed with their input. To that end, the goal of this project is to lay the groundwork for a synergistic, mobile intervention to reduce alcohol use and risky sex and prevent HIV among young adult MSM. This research study is made up of three related sub-projects: 1) a web-based survey; 2) a series of focus groups and 3) a small, preliminary acceptability and usability to study to test the mobile intervention. The proposed intervention to be tested on a preliminary basis in this study combines brief motivational intervention with daily interactive voice response (IVR) monitoring including personalized feedback. Ultimately, this combined intervention will also include pre-exposure prophylaxis (PrEP), however there will be no medication in this particular study. Each of these components has efficacy in enhancing treatment adherence, reducing alcohol and/or HIV risk but requires other interventions to maximize its potential benefit. Combining them will capitalize on the strength of each, leading to a higher impact alcohol and HIV preventive intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Web-survey:
- •Ages 18-30
- •Ability to read and write English
- •1 or more instances of sexual activity with another man in the past 3 months
- •HIV Negative
- •Focus group:
- •All other inclusion criteria will be the same as the web survey
- •Usability phase:
- •5 or more drinks in a day in the past month
- •Past-month intercourse with another man without a condom
- •Willingness to try PrEP, but have never tried it before
排除标准
- •Web Screen:
- •No subject may have lifetime use of PrEP
- •Focus group:
- •A current undergraduate or graduate student at any level in one of the 3 departments that make up the College of Health and Human Performance (HHP) at the University of Florida (UF), where Dr. Leeman's faculty appointment is.
- •Do not want to engage in open discussion regarding substance use or sexual activity/orientation in a group setting. It will be possible for participants to contribute to focus group discussions without providing detailed information about their own substance use or sexual activity, however focus group participants must have a degree of openness to discussing these topics with others. These groups will take place with 6-7 other people and some people may be made uncomfortable by the discussions that may take place with regard to participants' drinking, substance use or sexual behavior.
- •Not willing to be recorded via an electronic recording device
- •Usability phase:
- •No subject may have lifetime use of PrEP
- •Those who do not wish to provide a reliable phone number will be excluded
结局指标
主要结局
High-risk Sexual Behavior: Condomless Sex
时间窗: Retrospective self-report from past month on web survey
Past month frequency of condomless sex
Quantity of Alcohol Consumption
时间窗: Retrospective self-report over the past month
Determine levels of alcohol consumption in study population
High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use
时间窗: Past month on a self-report survey
Past month frequency of alcohol use before or during oral, anal and/or vaginal sex
Study Participant Opinions on Acceptability of Intervention Content
时间窗: Up to one month
Participants in the usability study will report on the acceptability of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. On a modified System Usability Scale, participants in the usability study will report on the acceptability (i.e., perceived value, liking) of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. Items were rated on a 1-7 scale with higher scores indicating greater usability. The acceptability subscale is made up of 5 items. The score reported below is the mean of these five items.
Study Participant Opinions on Usability of Intervention Content
时间窗: Up to 1 month
On a modified System Usability Scale, participants in the usability study will report on the usability of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. Items were rated on a 1-7 scale with higher scores indicating greater usability. The usability subscale is made up of 4 items. The score reported below is the mean of these four items.
次要结局
未报告次要终点