适应性随机对照试验 (ADAP-TIV)
2022年11月21日 更新者:Max O'Donnell、Columbia University
MHealth 和常规依从性支持干预措施的适应性评估,以优化南非耐药结核病和 HIV 新治疗方案的结果
这是一项前瞻性、适应性、随机对照试验,比较 4 种干预组对确诊耐多药结核病成人的综合终点的有效性,HIV 启动含贝达喹啉的耐多药结核病治疗方案和 ART(整合酶链转移抑制剂 (INSTI)-基于固定剂量联合疗法)在南非夸祖鲁-纳塔尔省。
干预措施包括:提高护理标准;社会心理支持; mHealth 使用支持蜂窝的电子剂量监测;结合 mHealth 社会心理支持。
将使用差异化服务提供 (DSD) 对治疗支持需求的知情评估来调整支持水平。
研究概览
详细说明
本研究将遵循 4 臂贝叶斯自适应试验设计。 随着患者的入组,他们将被随机分配到四个组中的一个。
该研究将在一个共同的结构内进行,以便进行有效的注册和分析。 整体结构是一个 4 臂自适应平台,由差异化服务交付 (DSD) 方法提供信息,支持 mHealth 和社会心理依从性支持干预措施。
目标 1 是一项对 mHealth 和社会心理依从性支持干预的适应性研究,使用贝叶斯适应性设计来允许单独和组合地比较干预的元素。 目标 1 参与者将被随机分配到 4 个组中的一个,并在 6 个月的干预期间每月进行随访,然后通过电话进行治疗结束,并进行一次额外的面对面访问以确定主要结果。 主要结果是 12 个月时的综合临床/生物学结果,如下所述。 假设 1a 使用所有参与者,而假设 1b 仅使用 mHealth 干预组 (3+4) 中的参与者,因为需要精细的 EDM 测量依从性。
研究类型
介入性
注册 (预期的)
360
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。
学习联系方式
- 姓名:Kogieleum Naidoo, Prof
- 电话号码:+27 31 260 4687
- 邮箱:Kogie.Naidoo@caprisa.org
研究联系人备份
- 姓名:Max O'Donnell, Prof
- 邮箱:mo2130@columbia.edu
学习地点
-
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KwaZulu-Natal
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Durban、KwaZulu-Natal、南非、4001
- King DinuZulu 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
不
有资格学习的性别
全部
描述
纳入标准:
- MTB 培养或分子检测呈阳性
- HIV 分子检测呈阳性或有记录的 HIV 阳性病史
- 通过分子(即 GeneXpert MTB/RIF)或与至少对利福平耐药的结核病一致的常规检测,
- 在入组后 4 周内开始使用含 Bedaquiline 的结核病治疗方案并首次接受 BDQ 治疗
- 使用抗逆转录病毒疗法 (ART) 方案进行治疗,包括含多替拉韦的联合抗逆转录病毒疗法方案(即 Tenofovir-Lamivudine-Dolutergravir),或在入组后 4 周内开始,
- isiZulu 或英语的知情同意能力
排除标准:
- 怀孕
- 犯人
- IOR 或临床医生的自由裁量权
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:提高护理标准
|
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其他:社会心理支持
|
使用自适应随机平台比较依从性支持干预对临床和生物学终点的影响。
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其他:移动健康
Wisepill 设备是使用 2G/3G 蜂窝网络的 RT2000 蜂窝电子药盒。
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使用自适应随机平台比较依从性支持干预对临床和生物学终点的影响。
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其他:移动健康和社会心理支持
Arm 2 和 Arm 3 的组合。
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使用自适应随机平台比较依从性支持干预对临床和生物学终点的影响。
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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 |
---|---|---|
生物学结果
大体时间:06月
|
结核菌培养转化
|
06月
|
临床结果
大体时间:12个月
|
生存
|
12个月
|
生物学结果
大体时间:12个月
|
艾滋病病毒载量
|
12个月
|
临床结果
大体时间:12个月
|
保留护理
|
12个月
|
生物学结果
大体时间:12个月
|
结核菌培养转化
|
12个月
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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:Max O'Donnell, Prof、University of Columbia
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。
一般刊物
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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 (预期的)
2023年2月1日
初级完成 (预期的)
2025年2月1日
研究完成 (预期的)
2027年2月1日
研究注册日期
首次提交
2022年11月21日
首先提交符合 QC 标准的
2022年11月21日
首次发布 (实际的)
2022年12月1日
研究记录更新
最后更新发布 (实际的)
2022年12月1日
上次提交的符合 QC 标准的更新
2022年11月21日
最后验证
2022年11月1日
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.
艾滋病毒感染的临床试验
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Hospital Clinic of Barcelona完全的
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Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
依从性支持干预的临床试验
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完全的
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center邀请报名
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Women's College HospitalRyerson University撤销
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Potomac Health FoundationsNational Institutes of Health (NIH); National Institute of Drug Abuse招聘中