感染 HIV 的孕妇的 ART 准备
2018年9月14日 更新者：University of North Carolina, Chapel Hill
感染 HIV 的孕妇的 ART 准备情况：从形成性定性研究到个体随机试验
本研究旨在评估赞比亚感染 HIV 的孕妇是否准备好根据卫生部的选项 B+ 政策开始、坚持和继续接受护理。
在一项分为 3 阶段的研究中，研究人员将：(1) 对孕妇开始终生 ART 的准备情况进行形成性研究； (2) 将形成性研究的结果转化为适合选项 B+ 的孕妇的准备情况评估工具和增强依从性方案，以及 (3) 对增强依从性方案进行个体随机试验。
研究概览
详细说明
这是一项定性和定量研究，旨在探讨患者是否准备好在感染 HIV 的孕妇中开始终生 ART，以及 ART 在怀孕期间和分娩后对 HIV 护理和治疗的坚持和保留。
第一阶段研究的目标如下：
- 确定关于在妊娠背景下接受 ART 资格后的几天和几周内患者准备好开始 ART 的共同主题
- 了解感染艾滋病毒的妇女和育龄妇女的伴侣认为将有助于每天坚持三联药物抗逆转录病毒治疗并在怀孕期间和分娩后保持护理的策略
第二阶段研究的目标如下：
- 开发用于评估怀孕期间启动 ART 准备情况的筛查工具
- 试行 ART 准备评估工具并通过定性研究评估其可接受性和可行性
- 设计一种系统地解决患者准备障碍的组合干预措施，这样做可能会缩短从 HIV 诊断到开始抗逆转录病毒治疗的时间，并在短期内提高抗逆转录病毒治疗的依从率和护理保留率
第三阶段研究的目标如下：
- 评估增强的依从性包，以改善及时启动 ART 和保持护理，定义为参加 ART 合格后 30 天的随访 ART 和分娩时母体 HIV 病毒水平
- 通过查看早期 ART 依从性和保留率来确定筛查工具在预测 ART 准备情况方面的准确性
- 获得有关选择 B+ 的 HIV 感染妇女妊娠期和产后病毒学反应的早期数据
- 获得有关选项 B+ 的 HIV 感染妇女 6 周和 6 个月 MTCT 率的数据
- 考虑到替诺福韦在赞比亚是一线药物，选择 B+ 的 HIV 感染妇女在怀孕和产后期间的肾功能数据
研究类型
介入性
注册 (实际的)
454
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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Lusaka、赞比亚
- Centre for Infectious Disease Research in Zambia
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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
标准因研究阶段而异，如下所示：
阶段1
纳入标准：
- 尚未接受 ART 或治疗的 HIV 感染孕妇
- 接受 ART 或治疗的感染 HIV 的孕妇或产后妇女
- 最近或正在怀孕的女性的伴侣
排除标准：
- 未满 18 岁
- 已知的精神病史
阶段2
纳入标准：
- 试行测试准备评估工具的接受抗逆转录病毒治疗的感染艾滋病毒的孕妇或产后妇女或
- 参与在卫生机构提供 PMTCT 和/或 ART 服务的卫生保健工作者已经对准备评估工具进行了试点测试
第三阶段
纳入标准：
- 孕
- HIV感染者
- 以前从未为了自己的健康发起或接受过 ART
- 能够提供知情同意
- 愿意接受所有的研究测试和程序，并被跟踪直到产后 6 个月
排除标准：
- 未满 18 岁
- 已知的宫内胎儿死亡
- 已知的精神病史
- 不打算在卢萨卡区的政府医疗机构接受产前护理、分娩护理和产后护理
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：卫生服务研究
- 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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其他：护理标准
卫生部推荐的方法是选择在怀孕期间停止 HIV 检测，然后立即为感染 HIV 的孕妇启动 ART。
ART 启动伴随着咨询，旨在教育和准备妇女接受并终身接受 ART。
不返回进行临床或药物补充访问的妇女将通过电话或亲自进行追踪。
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目前，护理标准基于 2010 年国家 HIV 护理和治疗指南，鼓励医疗保健提供者使用多种不同的方法来提高 ART 依从性。
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实验性的：增强依从性包
增强依从性方案将根据形成性研究的结果设计。
该干预措施将支持符合选项 B+ 条件下的 ART 的女性。
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增强依从性方案尚未设计，但可能针对所有感染艾滋病毒的妇女，其方法目前仅适用于迟到的客户或身份不明的客户。
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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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启动 ART 并继续接受护理的女性比例
大体时间：根据选项 B+ 政策，在有资格开始 ART 的 30 天内
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选项 B+ 设置中的 ART 资格通常是在产前检查期间新诊断出感染 HIV 的孕妇的 HIV 诊断日期，或者是已知感染 HIV 的孕妇首次产前检查的日期，但尚未进行产前检查关于艺术
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根据选项 B+ 政策，在有资格开始 ART 的 30 天内
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分娩时 HIV 病毒学抑制
大体时间：交货时间
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分娩时病毒学抑制的结果将分析 SOC 组和干预组之间的差异。
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交货时间
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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从 ART 资格到 ART 启动的时间
大体时间：从 ART 资格到开始注册到产后 6 个月的时间
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从 ART 资格到开始注册到产后 6 个月的时间
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HIV 母婴传播
大体时间：在出生后 6 周零 6 个月时
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在出生后 6 周零 6 个月时
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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：Mwangelwa Mubiana, MBChB、Centre for Infectious Disease Research in Zambia
- 首席研究员：Benjamin Chi, MD、University of North Carolina, Chapel Hill
- 研究主任：Michael J Vinikoor, MD、Centre for Infectious Disease Research in Zambia
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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- Naar-King S, Parsons JT, Murphy D, Kolmodin K, Harris DR; ATN 004 Protocol Team. A multisite randomized trial of a motivational intervention targeting multiple risks in youth living with HIV: initial effects on motivation, self-efficacy, and depression. J Adolesc Health. 2010 May;46(5):422-8. doi: 10.1016/j.jadohealth.2009.11.198. Epub 2010 Feb 4.
- Mubiana-Mbewe M, Bosomprah S, Kadota JL, Koyuncu A, Kusanathan T, Mweebo K, Musokotwane K, Mulenga PL, Chi BH, Vinikoor MJ. Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial. AIDS Behav. 2021 Mar;25(3):992-1000. doi: 10.1007/s10461-020-03060-4. Epub 2020 Oct 8.
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5月1日
初级完成 (实际的)
2018年5月9日
研究完成 (实际的)
2018年5月28日
研究注册日期
首次提交
2015年5月14日
首先提交符合 QC 标准的
2015年6月1日
首次发布 (估计)
2015年6月2日
研究记录更新
最后更新发布 (实际的)
2018年9月18日
上次提交的符合 QC 标准的更新
2018年9月14日
最后验证
2018年9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.
护理标准的临床试验
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Bionano GenomicsColumbia University; University of Iowa; Medical College of Wisconsin; Augusta University; University... 和其他合作者招聘中
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Compedica IncProfessional Education and Research Institute招聘中
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Integra LifeSciences CorporationIntegrium终止
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DeRoyal Industries, Inc.Lincoln Memorial University完全的
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National Institute of Allergy and Infectious Diseases...Institut National de la Santé Et de la Recherche Médicale, France; The Ministry of Health and... 和其他合作者完全的
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Spaulding Rehabilitation HospitalGoldenGait LTD招聘中
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University of Stellenbosch完全的
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Oregon Health and Science University未知