A Pilot Gaming Adherence Program for Youth Living With HIV
研究概览
地位
详细说明
Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have suboptimal rates of retention in care and adherence to antiretroviral medication (ARV) treatment. There are few adherence studies with YLWH and the results are mixed, so there is a great need for the development of novel interventions. Results of adult HIV adherence studies indicate that participants are interested in using technology-based methods and are most receptive toward interventions that couple technological devices with motivational components. Pill taking monitoring devices have been found to be a sensitive measure of adherence to ARV medications, but do not lead to sustained improvements in adherence or intrinsic motivation when used alone. Building on this knowledge, this study will examine a multi-level technology that integrates a medication monitoring device WITH an interactive smartphone based app/game that is attractive and engaging to YLWH. This multi-level approach will integrate theory driven content with novel, but intuitive, technology to improve HIV treatment adherence.
In this study, data on opening of the pill bottle will be transferred wirelessly from the bottle cap and a text on adherence sent to the phone. This developmental project will adapt and refine a smartphone app/game to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. Creation and adaptation will occur from in-depth interviews with YLWH on ART (n=25) and an open trial of the Intervention (n=20). While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about HIV treatment), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners). A small randomized controlled pilot study (24 weeks) among 60 YLWH will examine the preliminary efficacy of the IMB Gaming Adherence Intervention (integration of the smart cap with the IMB informed app/game) compared to a comparison group who receive the smart cap and smartphone but no IMB game, on adherence and biological measures.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Rhode Island
-
Providence、Rhode Island、美国、02903
- Rhode Island Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- English speaking
- in medical care for HIV and receiving antiretroviral treatment
- aware of their HIV status as per clinician and clinical record
- able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment
- detectable viral load
Exclusion Criteria:
- none
学习计划
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:IMB Gaming Adherence Intervention
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
|
有源比较器:Enhanced treatment as usual
Smart pill bottle cap and mobile phone but no game
|
Smart pill bottle cap and mobile phone but no game
|
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 |
|---|---|---|
|
Log10 HIV-1 Viral Load
大体时间:24 weeks
|
Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
|
24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electronically Measured Past 7-day Adherence
大体时间:24 weeks
|
Past 7 day medication adherence as measured by electronic medication monitoring device.
|
24 weeks
|
|
Number of Kept Medical Appointments
大体时间:24 weeks
|
Number of kept medical appointments since baseline.
|
24 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale
大体时间:24 weeks
|
Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale.
This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment.
Five items were summed to get a total Behavioral Skills subscale score.
Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment.
|
24 weeks
|
合作者和调查者
调查人员
- 首席研究员:Larry K Brown, MD、Rhode Island Hospital
- 研究主任:Laura Whiteley, MD、Rhode Island Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.