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以小组为基础的干预措施，以改善资源匮乏环境中感染艾滋病毒的青年的心理健康和依从性

2026年5月21日 更新者：International Maternal Pediatric Adolescent AIDS Clinical Trials Group

IMPAACT 2016 - 评估以小组为基础的干预措施，以改善资源匮乏环境中感染 HIV 的青少年的心理健康和抗逆转录病毒疗法 (ART) 依从性

IMPAACT 2016 是一项多站点、双臂、单独随机对照研究，旨在评估土著青年领袖 (IYL) 提供的创伤知情认知行为疗法 (TI-CBT) 的土著领袖外展模型 (ILOM) 是否与相关在资源有限的环境中，艾滋病病毒感染者的心理健康结果和抗逆转录病毒治疗依从性得到改善。 通过事先开展焦点小组和试点测试，使干预措施适应当地情况。

研究概览

地位

终止

条件

干预/治疗

详细说明

IMPAACT 2016 是一项多站点、双臂、单独随机对照研究，旨在评估土著青年领袖 (IYL) 提供的创伤知情认知行为疗法 (TI-CBT) 的土著领袖外展模型 (ILOM) 是否与相关在资源有限的环境中，艾滋病病毒感染者的心理健康结果和抗逆转录病毒治疗依从性得到改善。 为了根据当地情况调整干预措施，试验之前将使用“ADAPT-ITT”模型在每个站点调整 TI-CBT 干预措施，其中包括焦点小组和试点测试。 在随机研究中，青少年将被单独随机分配到 TI-CBT 干预组或讨论控制组。 参与者将在他们的随机分组中作为一个小组会面，并在八周内接受多个小组会议。 每组将包括平均 8 名青年，随机试验中大约共有 192-256 名青年（每组 96-128 名青年）。 每组中的 TI-CBT 和讨论控制组将是混合性别的，除非确定有必要在焦点小组期间拥有单一性别的小组。 看护人（如果可用并获得青少年许可）将被分配到与其青少年相同的研究组。 护理人员将作为一个小组在两个不同的星期内举行两次针对护理人员的会议，并与他们的青年小组会议分开。 青少年和看护人将在最后一次小组会议后立即完成一次随访，并在 6 个月和 12 个月时完成两次额外的随访。 在六个月的评估之后，青少年和看护者还将立即接受与他们分配的研究组一致的两小时助推小组会议。 加强课程旨在增强治疗效果并提高可持续性。 所有参与者完成为期六个月的评估后，将对这些评估的数据进行分析，以确定干预措施的短期效果。 将在完成随访后进行额外的分析，以评估干预的长期效果，包括加强小组会议的效果。

研究类型

介入性

注册 (实际的)

484

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

  • 南非
      • Soweto、南非
        • Soweto IMPAACT CRS 8052
  • 博茨瓦纳
      • Gaborone、博茨瓦纳
        • Gaborone Prevention/Treatment Trials CRS 12701
      • Molepolole、博茨瓦纳
        • Molepolole Prevention/Treatment Trials CRS 12702
  • 津巴布韦
      • Chitungwiza、津巴布韦
        • St. Mary's CRS 30303
      • Harare、津巴布韦
        • Harare Family Care CRS 31890
      • Harare、津巴布韦
        • Seke North CRS 30306
  • 马拉维
      • Blantyre、马拉维
        • College of Medicine CRS 30301
      • Lilongwe、马拉维
        • University of North Carolina Lilongwe CRS 12001

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

15年 至 19年 (孩子、成人、年长者)

接受健康志愿者

不

描述

纳入标准 - 对于青年参与者：

  • 筛选时，15-19 岁。
  • 如果达到法定年龄，可以提供由现场标准操作程序 (SOP) 确定并符合现场 IRB/EC 政策和程序的独立知情同意书：潜在的青年参与者愿意并能够提供书面知情同意书以参与研究。
  • 如果未达到提供独立知情同意的法定年龄：父母或监护人愿意并能够为参与研究提供书面知情同意，潜在的青少年参与者愿意并能够为参与研究提供书面知情同意。
  • 根据医疗记录中记录的在不同时间点收集的两个样本的记录测试或通过确认测试确认的 HIV 感染。
  • 在筛查时，意识到他或她的 HIV 感染，由记录调查员或指定人员确认。
  • 在筛查时，根据医疗记录文件，在筛查前至少接受了 24 周的 ART。

  • 在筛选时，至少满足以下中度至重度心理健康症状的指标之一：

    • 患者健康问卷 9 (PHQ-9) 评分 ≥ 10
    • 一般焦虑症 7 (GAD-7) 评分 ≥ 10
    • 加州大学洛杉矶分校创伤后应激障碍反应指数 (UCLA PTSD-RI) 得分 > 35

纳入标准 - 对于看护者参与者：

  • 照顾者，定义为亲生父母、法定监护人，或为参加随机试验的青少年提供情感、心理和/或信息护理的人，由青少年确定，青少年已为其提供书面参与许可在研究中。
  • 已达到法定年龄，可以提供独立的同意书，愿意并能够为参与研究提供书面知情同意书。

排除标准 - 对于青年参与者：

  • 在进入时，参与一项提供心理健康或 ART 依从性干预的研究。
  • 之前参加过 IMPAACT 2016 焦点小组或试点测试
  • 现场调查员认为会妨碍知情同意和知情同意、使研究参与不安全、使研究结果数据的解释复杂化或以其他方式干扰实现研究目标的任何其他情况、不利的社会情况或认知障碍。

排除标准 - 对于看护者参与者：

之前参加过 IMPAACT 2016 焦点小组或试点测试。

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
实验性的：Youth TI-CBT Intervention Arm
For youth, the TI-CBT intervention arm consisted of six 2-hour TI-CBT group sessions led by Indigenous Youth Leaders (IYL) during weeks 1 to 8 and one 2-hour booster group session at 6-months. The TI-CBT Intervention was delivered in a group format. The TI-CBT Intervention arm had 15 groups with an average of 8.5 youth per group (range 6-11).
行为的：Youth TI-CBT Intervention Arm
For youth, each TI-CBT group session was led by IYL. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches youth strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Youth Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.
有源比较器：Youth Discussion Control Arm
For youth, the Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months. The Discussion Control was delivered in a group format. The Discussion Control arm had 15 groups with an average of 8.4 youth per group (range 5-10).
行为的：Youth Discussion Control Arm
For youth, each discussion group session was led by IYL. Discussion topics were selected by youth in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.
实验性的：Caregiver TI-CBT Intervention Arm
For caregivers, the TI-CBT Intervention arm consisted of two 2-hour TI-CBT group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster group session at 6-months led by adult study staff. The TI-CBT Intervention was delivered in group format. The TI-CBT Intervention arm had 15 groups with an average of 7.7 caregivers per group (range 5-10).
行为的：Caregiver TI-CBT Intervention Arm
For caregivers, each TI-CBT group session was led by adult study staff. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Caregiver Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.
有源比较器：Caregivers Discussion Control Arm
For caregivers, the Discussion Control arm consisted of: two 2-hour discussion group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster discussion group session at 6 months led by adult study staff. The Discussion Control intervention was delivered in a group format. The Discussion Control arm had 15 groups with an average of 7.6 caregivers per group (range 3-10).
行为的：Caregiver Discussion Control Arm
For caregivers, each discussion group session was led by adult study staff. Discussion topics were selected by caregivers in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.

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
Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months
大体时间：at 6 months
Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm. The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms). A score of 10 or more points indicates moderate to severe anxiety symptoms.
at 6 months
Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months
大体时间：at 6 months
Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm. The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth. If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time". A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms). A score of 35 or more indicates moderate to severe PTSD symptoms. If no trauma is endorsed, no score is calculated.
at 6 months
Group-level Mean Composite Mental Health Measure at 6 Months
大体时间：at 6 months
Average (standard deviation) of the group-level mean Composite score within arm. Composite scores are a study-specific measure of combined mental health symptoms. A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores. The 3 Z scores are summed to obtain a Composite score. Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall. Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value.
at 6 months
Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months
大体时间：at 6 months
Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm. The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms). A score of 10 or more points indicates moderate to severe depression symptoms.
at 6 months

次要结果测量

结果测量
措施说明
大体时间
Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session)
大体时间：After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm. The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms). A score of 10 or more points indicates moderate to severe anxiety symptoms.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at IPL (Immediately Post Last Group Session)
大体时间：After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm. The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms). A score of 10 or more points indicates moderate to severe depression symptoms.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) at IPL (Immediately Post-Last Group Session)
大体时间：After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm. The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth. If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time". A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms). A score of 35 or more indicates moderate to severe PTSD symptoms. If no trauma is endorsed, no score is calculated.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean Composite Mental Health Measure at IPL (Immediately Post-Last Group Session)
大体时间：After initial treatment completion (initial treatment lasted an average of 6 weeks)
Average (standard deviation) of the group-level mean Composite score within arm. Composite scores are a study-specific measure of combined mental health symptoms. A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores. The 3 Z scores are summed to obtain a Composite score. Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall. Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value.
After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean ART Adherence at 6 Months
大体时间：at 6 months
Average (standard deviation) of the group-level mean antiretroviral therapy (ART) adherence score within arm. The Wilson 3-Item Adherence Scale assessed self-reported ART adherence. Within the past 30 days, the 3 items correspond to missed daily doses (0-30), adherence to medication instructions ("Very poor" to "Excellent"), and frequency of perfect use ("Never" to "Always"). Responses on the three items are transformed linearly to scores between 0 and 100 points and averaged to obtain a single score. Scores range from 0 (worst) possible adherence to 100 (best possible adherence).
at 6 months
Viral Load at 6 Months
大体时间：at 6 months
HIV-1 RNA
at 6 months
Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session).
大体时间：After initial treatment completion (initial treatment lasted an average of 6 weeks).
Self-report - Wilson 3-item scale (range 0-100, higher=better)
After initial treatment completion (initial treatment lasted an average of 6 weeks).
Viral Load at IPL (Immediately Post-Last Group Session)
大体时间：After initial treatment completion (initial treatment lasted an average of 6 weeks)
HIV-1 RNA
After initial treatment completion (initial treatment lasted an average of 6 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。

赞助

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

合作者

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

调查人员

  • 学习椅：Dorothy Dow, MD, MSc、Duke University

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

  • Dow DE, Libous J, Ponatshego PL, Masheto G, Mvalo T, Payesa C, Buckley J, Stranix-Chibanda L, Nematadzira T, Vhembo T, Ace A, Warshaw M, Townley E, Lee S, Allison S, Donenberg G and the IMPAACT 2016 Team. High levels of mental distress among youth with HIV in Southern Africa: A description of enrollment into IMPAACT 2016, a randomized controlled trial of a peer-led, group-based mental health intervention. Presented at IAS, Kigali, Rwanda, 15 July 2025.
  • Libous J, Jeffrey R, George K, Montañez N, Warshaw M, Shakes Raesi M, Ponatshego PL, Maliwichi L, Vhembo T, Mutasa T, Bere CT, Galvin L, Townley E, Varechtchouk O, Dow D, Donenberg G, and the IMPAACT 2016 Team. IMPAACT 2016: The ADAPT-ITT Framework Leveraging Youth and Supporter Voices in the Adaptation of a Trauma-Informed Cognitive Behavioral Therapy Group-Based Intervention for Youth Living with HIV and Mental Health Distress. Presented at Fast Track Cities, Paris, France, 13-15 October 2024.
  • Vhemo T, Mhembere T, Mbengeranwa T, Bere TC, Mutasa T, Katsande R, Gumbo J, Mudzonga N, Nematadzira T, Maturure SJ, Mandima PF, Maonera S, Stranix-Chibanda L. High Prevalence of Common Mental Health Disorders Amongst Adolescents With HIV in Zimbabwe: IMPAACT 2016; Presented at International Workshop on Pediatrics & HIV, Munich, Germany, 19-20 July 2024.
  • Libous JL, Montañez N, Donenberg G, Kapetanovic S, Dow D. IMPAACT 2016: Operationalizing the ADAPT-ITT Model to drive local adaptation of an intervention to improve mental health and medication adherence in youth living with HIV. Presented at Society for Clinical Research Associates 29th Annual Conference, Virtual, 23-26 September 2020.
  • Warshaw M, Dow D, Kapetanovic S, Libous J, Reding C, Montañez , Donenberg G. IMPAACT 2016: Interdisciplinary Collaboration at Multiple Levels. Society for Clinical Trials 41st Annual Meeting, Baltimore, MD (Virtual), 2020.
  • Libous JL, Montanez NA, Dow DE, Kapetanovic S, Buckley J, Kakhu TJ, Kamthunzi P, Maliwichi LA, Vhembo T, Chawana TD, Nematadzira T, Donenberg GR. IMPAACT 2016: Operationalizing HIV Intervention Adaptations to Inform the Science and Outcomes of Implementation. Front Reprod Health. 2021 May 28;3:662912. doi: 10.3389/frph.2021.662912. eCollection 2021.

有用的网址

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)

2024年4月6日

初级完成 (实际的)

2025年3月27日

研究完成 (实际的)

2025年6月5日

研究注册日期

首次提交

2019年7月2日

首先提交符合 QC 标准的

2019年7月16日

首次发布 (实际的)

2019年7月18日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IMPAACT 2016
  • DAIDS ID #38506 (其他标识符：DAIDS/NIAID/NIH)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在去标识化后，作为出版物结果基础的个人参与者数据。

IPD 共享时间框架

从出版后三个月开始，在 NIH 的国际母婴青少年艾滋病临床试验 (IMPAACT) 网络资助期间可用。

IPD 共享访问标准

数据将与研究人员共享，他们提供了使用经 IMPAACT 网络批准的数据的方法学上合理的建议。

分析类型：专门用于实现 IMPAACT 网络批准的提案中的目标所需的分析类型。

机制：研究人员可以使用 IMPAACT“数据请求”表格提交数据访问请求，网址为：https://www.impaactnetwork.org/resources/study-proposals.htm。 获批提案的研究人员需要在收到数据之前签署 IMPAACT 数据使用协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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