A Multilevel Gaming Intervention for Persons on PrEP
2020年12月17日 更新者：Laura Whiteley、Rhode Island Hospital
This study will develop and test a novel, smartphone based gaming intervention to improve adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to decrease HIV risk behaviors among men who have sex with men (MSM).
In the intervention, participants will engage with an immersive app/game on their iPhone.
While gaming, participants will gain information about their health, improve motivation for PrEP and medical appointment adherence, and practice healthy behaviors.
If the intervention is found to be effective, it can be tested in a larger study and then disseminated to other people taking PrEP.
研究概览
详细说明
The use of antiretroviral medications to reduce the risk of acquiring HIV infection (Pre-exposure Prophylaxis, PrEP) is an efficacious and promising new prevention strategy. In published studies, failure of PrEP was associated with poor adherence and low plasma drug levels. This indicates that optimal PrEP treatment will require behavioral interventions to promote adherence. Averting increases in risk behavior will also be essential for maintaining PrEP's protective effects. Interventions will need to address on-going HIV risk behavior and be relevant for persons using PrEP (e.g. young adult MSM). Borrowing from recent literature in HIV prevention and treatment adherence, interventions that utilize intuitive easy to use technologies with motivational components show promise for behavior change and dissemination.
This study will examine an interactive smartphone based app/game that is immersive and appealing. This novel, but intuitive multi-level technology will measure PrEP adherence, promote engagement in treatment and safe sexual behavior. The smartphone app/game will be developed to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about PrEP treatment and HIV), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners, condom self efficacy). In-depth interviews with young adults on PrEP and an open trial of the intervention will inform the development of the intervention and procedures. A small randomized controlled pilot study among 50 participants on PrEP will examine the preliminary efficacy of the intervention (IMB informed app/game). It is hypothesized that, compared to subjects in the control group, participants in the IMB Gaming Intervention will show: improved adherence to PrEP, higher blood ARV levels, decreased HIV risk behaviors, and improved self efficacy and attitudes for PrEP treatment adherence.
The specific aims are:
- To create an engaging and absorbing smartphone based app/game with content consistent with the Information-Motivation-Behavioral Skills (IMB) model to measure and improve PrEP treatment adherence and safer sex behaviors, and to receive feedback on the game's utility and acceptability from in-depth interviews with MSM (estimated mean age 27).
- To conduct an open trial of the IMB Gaming Intervention with MSM to obtain further qualitative and quantitative information on its acceptability, and feasibility. These data will be used to modify the approach and technology as needed.
- To evaluate, in a 24 week randomized controlled pilot study (n=50), the preliminary efficacy of the IMB Gaming Intervention compared to a time, attention, and technology matched group. Investigators will examine the impact of the IMB Gaming Intervention in improving treatment adherence (measured by clinic visits attended, self-report) and biological measures (ARV levels). Investigators will also examine the impact on HIV risk behaviors.
研究类型
介入性
注册 (实际的)
82
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria: All males on PrEP over the age of 18
- English speaking
- Receiving prophylactic antiretroviral treatment
- Not enrolled in another PrEP related study
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
Exclusion Criteria:
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学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
Subjects in the intervention group will each receive a smartphone with a data service plan as the active arm.
The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play.
The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills.
Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones.
Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
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无干预：Comparison
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention.
Subjects in COMP will each receive smartphones with the same data service plan as the active arm.
Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr.
Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ).
This is the same game that Viral Combat is being adapted from.
Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content.
Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-Report of PrEP Adherence
大体时间：24 weeks
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Self-report measure of adherence in the past 7 days categorized as "optimal" (0-3 missed doses in the past 7 days) versus "suboptimal" (4-7 missed doses in the past 7 days).
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24 weeks
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ARV (TFV-DP) Levels
大体时间：24 weeks
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Intracellular TFV-DP will be measured in red blood cells using dried blood spots.
TFV-DP levels provide a measure of long-term adherence over the preceding month (like hemoglobin A1C).
The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average (e.g.
7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average).
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24 weeks
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Average Number of Days on PrEP Per Week
大体时间：24 weeks
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The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average in the past month (e.g.
7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average).
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24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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HIV Knowledge at 24 Weeks
大体时间：24 weeks
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The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 5 items with "true," "false," or "do not know" response options.
Total scores range from 0 to 5. Higher scores indicate greater knowledge.
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24 weeks
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Motivational Readiness for Adherence at 24 Weeks
大体时间：24 weeks
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Rollnick's Readiness Ruler will be used to assess motivation for adherence to medication and medical visits.
Respondents rate how ready they are to take PrEP as prescribed on a scale from 1 (not ready) to 10 (ready to be consistent or already consistent) each month.
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24 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Social Support for Medication Adherence
大体时间：24 weeks
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This six item measure assesses social support for taking medications, going to medical appointments and other tasks related to adherence using Likert style items with a four point scale.
Scores range from 6 to 24 Higher scores indicate greater social support.
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24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Laura Whiteley, MD、Brown University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年4月1日
初级完成 (实际的)
2018年11月1日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2015年11月3日
首先提交符合 QC 标准的
2015年11月19日
首次发布 (估计)
2015年11月20日
研究记录更新
最后更新发布 (实际的)
2021年1月12日
上次提交的符合 QC 标准的更新
2020年12月17日
最后验证
2020年12月1日
更多信息
与本研究相关的术语
其他研究编号
- 1R34MH104068 (美国 NIH 拨款/合同)
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