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A Pilot Gaming Adherence Program for Youth Living With HIV

2018年8月28日 更新者:Dr. Larry K. Brown、Rhode Island Hospital
This study will develop and test a novel, technology based intervention to improve treatment adherence among youth living with HIV who are taking antiretroviral medication. In the intervention youth will access an engaging and immersive app/game on their smartphone.Data about the opening of the smart pill bottle will be transferred from the bottle cap wirelessly and will trigger a text message about their adherence. While gaming, participants will gain information about their health, improve motivation for ARV 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 youth on antiretroviral medications.

研究概览

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

介入性

注册 (实际的)

66

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

    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital

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

14年 至 26年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

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

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: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

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: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

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。

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)

2012年9月1日

初级完成 (实际的)

2017年1月9日

研究完成 (实际的)

2017年8月1日

研究注册日期

首次提交

2013年6月24日

首先提交符合 QC 标准的

2013年6月25日

首次发布 (估计)

2013年6月26日

研究记录更新

最后更新发布 (实际的)

2018年9月26日

上次提交的符合 QC 标准的更新

2018年8月28日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01HD074846-01 (美国 NIH 拨款/合同)

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.

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