针对 HIV+ 非裔美国人的抗逆转录病毒治疗依从性干预的随机对照试验
2022年12月21日 更新者：RAND
Project Rise 是一项随机对照试验 (RCT)，针对感染 HIV 的非裔美国人进行创新的、文化上一致的治疗教育 (TE) 干预，其目标是导致健康差异的文化和社会问题。
研究概览
详细说明
Project Rise 是一项随机对照试验 (RCT)，针对感染 HIV 的非裔美国人进行创新的、文化上一致的治疗教育 (TE) 干预，其目标是导致健康差异的文化和社会问题。 TE 促进患者在医疗系统中的导航，并提供治疗教育和以客户为中心的咨询，以提高护理的依从性和保留率。 TE 通过提倡提供者改善患者与提供者之间的关系、建议改变治疗和/或提供者以及将患者转介给心理健康和社会服务来解决医疗保健和患者生活中的结构性问题。
将通过 APLA Health 招募总共 350 名黑人参与者，并随机分配到干预组或常规护理对照组（每组 175 人）。 从基线到基线后 13 个月，每天（并每两个月下载一次）电子监测依从性。 将在基线和基线后 6 个月和 13 个月通过静脉穿刺评估病毒载量。 据推测，随着时间的推移，干预组将表现出更好的依从性，并且比对照组更有可能抑制病毒载量。
研究类型
介入性
注册 (实际的)
306
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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California
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Los Angeles、California、美国、90016
- AIDS Project Los Angeles
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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
不
有资格学习的性别
全部
描述
纳入标准：
- HIV阳性
- 18岁或以上
- 自认为非裔美国人/黑人
- 在过去 12 个月内接受过抗逆转录病毒疗法 (ART)
- 自我报告的依从性问题（即 过去一个月至少错过了 1 次 ART 剂量）和/或可检测到的病毒载量
- 愿意使用药物事件监测系统 (MEMS) 进行电子依从性监测。
排除标准：
- HIV阴性
- 17 岁或以下
- 未自我认定为非裔美国人/黑人，未接受抗逆转录病毒治疗 (ART) 或在过去 12 个月内未接受 ART 治疗
- 没有自我报告的依从性问题和/或没有可检测到的病毒载量
- 不愿意使用药物事件监测系统 (MEMS) 进行电子依从性监测。
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：支持治疗
- 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 |
|---|---|
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实验性的：崛起 - 治疗教育
Rise 包括为期一个月的强化干预（在第 1、2 和 4 周有 3 次 60 分钟的核心咨询会议），然后是两次加强会议（在第 12 和 20 周）。
如果参与者在加强课程期间表现出不依从性，他们将获得最多四次额外的加强课程（即，如果在过去一个月内服用了 <85% 的规定剂量，则额外加强课程）。
因此，参与者在第一个月接受三个核心课程，然后在接下来的四个月接受 2-6 个强化课程。
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Rise 包括为期一个月的强化干预（在第 1、2 和 4 周进行三个 60 分钟的核心咨询课程），然后是两个加强课程（在第 12 和 20 周）。
如果参与者在加强课程期间表现出不依从性，他们将获得最多四次额外的加强课程（即，如果
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无干预：控制 - 无治疗教育
常规护理对照组将仅通过其 HIV 诊所接受标准护理。
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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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持续坚持
大体时间：基线后 7、8、9、10、11 和 12 个月的基线（治疗前）和治疗后观察
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电子监测规定的服用剂量百分比。
在这里，我们展示了在分析中使用的所有时间点收集的所有数据。
使用干预后所有 6 个月（基线后第 7 至 12 个月）的连续依从性测量，通过重复测量回归进行干预效果的评估，并且仅限于那些在基线时有依从性数据的人。
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基线后 7、8、9、10、11 和 12 个月的基线（治疗前）和治疗后观察
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二分依从性
大体时间：基线后 7、8、9、10、11 和 12 个月的基线（治疗前）和治疗后观察
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根据电子监测，报告服用大于或等于规定剂量 75% 的参与者人数。
在这里，我们展示了在分析中使用的所有时间点收集的所有数据。
使用干预后所有 6 个月（基线后第 7 至 12 个月）的依从性测量，通过重复测量回归进行干预效果的评估，并且仅限于那些在基线时有依从性数据的人。
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基线后 7、8、9、10、11 和 12 个月的基线（治疗前）和治疗后观察
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病毒抑制
大体时间：基线后 7 个月和 12 个月的基线（治疗前）和治疗后观察结果。对于 7M，如果在调查完成后 90 天内使用医疗记录； 13 个月，如果在调查前 90 天内或调查后 180 天内使用医疗记录
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根据静脉穿刺或医疗记录检测不到病毒载量
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基线后 7 个月和 12 个月的基线（治疗前）和治疗后观察结果。对于 7M，如果在调查完成后 90 天内使用医疗记录； 13 个月，如果在调查前 90 天内或调查后 180 天内使用医疗记录
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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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内化的 HIV 耻辱感
大体时间：基线后 7 个月和 12 个月的基线（治疗前）和治疗后观察
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衡量标准是“略微同意”或“强烈同意”“大多数艾滋病患者对他们的疾病负有责任”或“艾滋病患者一定做错了事并应受到惩罚”的参与者的计数。
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基线后 7 个月和 12 个月的基线（治疗前）和治疗后观察
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医疗不信任
大体时间：基线后 7 个月和 12 个月的基线（治疗前）和治疗后观察
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结果是对 9 种与 HIV 相关的阴谋信念的平均同意，每一种都以 5 分制衡量，从 1 = 强烈不同意到 5 = 强烈同意。
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基线后 7 个月和 12 个月的基线（治疗前）和治疗后观察
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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。
赞助
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)
2018年1月23日
初级完成 (实际的)
2021年11月7日
研究完成 (实际的)
2021年11月7日
研究注册日期
首次提交
2017年10月30日
首先提交符合 QC 标准的
2017年11月1日
首次发布 (实际的)
2017年11月6日
研究记录更新
最后更新发布 (实际的)
2023年1月18日
上次提交的符合 QC 标准的更新
2022年12月21日
最后验证
2022年12月1日
更多信息
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