Streamlined Treatment and Evidence-based Adolescent Counseling and Medication Support (STREAMS) (STREAMS)
2026年6月4日 更新者：Philip Kreniske、City University of New York, School of Public Health
Combination interventions to address mental health and adherence to HIV care in low- and middle-income countries (LMICs), are crucial to achieving the UNAIDS 95-95-95 targets as one in four adolescents living with HIV (ALWHIV) experience poor mental health and this contributes to suboptimal medication adherence and lack of viral suppression.
Yet few evidence-based mental health and adherence interventions have been evaluated in sub-Saharan Africa (SSA), the region where the majority of the 1.7 million ALWHIV reside.
STREAMS will determine if our streamlined combination intervention approach to mental health screening, provision of evidence-based interpersonal psychotherapy groups (IPT-G), and evidence-based family strengthening, and medication counseling is feasible and efficacious for ALWHIV in Uganda.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
588
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：Philip Kreniske, PhD
- 电话号码：(646) 364-9600
- 邮箱：philip.kreniske@sph.cuny.edu
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
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Living with HIV with confirmation by medical report and aware of their status
- Living within a family (defined broadly, not necessarily with biological parents); - - Between the ages of 15 to 19 years
- Prescribed ART
- Score a 10 or greater on the PHQ-9
Exclusion Criteria:
- an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or caregiver.
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：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：streamlined IPT-G with streamlined Suubi+Adherence
Streamlined IPT-G (6 weeks) one 90-min StrongMinds group counseling session per week & Suubi+Adherence (36 weeks)
|
Participants in this intervention arm will receive:
The sessions will focus on:
|
|
实验性的：streamlined IPT-G with SOC ART counseling
Streamlined IPT-G (6 weeks) as described above & Standard Of Care (SOC) ART counseling (8 weeks) individual 30-min counseling sessions once per week
|
The sessions will focus on:
|
|
无干预：SOC mental health counseling with SOC ART counseling.
Receive treatment per Uganda national guidelines Standard Of Care (SOC) Mental Health Counseling (6-weeks) delivered by HIV clinic staff in 60-min sessions once per week and SOC ART counseling (8-weeks).
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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 |
|---|---|---|
|
Depressive symptomatology
大体时间：Baseline to 24 months post-intervention initiation
|
PHQ-9, a standardized 9-item self-report instrument used to assess depression, is used.
Participants rate the frequency of their symptoms over the past 2 weeks.
Items are rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), and scale scores range from 0 to 27.
PHQ-9 scores of 5 to 9 represent minimal to mild depression and 10 to 20 represent moderate to severe depression.
A score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression.
|
Baseline to 24 months post-intervention initiation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Viral Load
大体时间：Baseline to 12-months post intervention initiation
|
Viral Load (VL) Suppression (Biological assay) will be assessed through blood draws.
In accordance with in-country cutoffs, VL will be dichotomized between undetectable (< 200 copies/ml) and detectable (≥ 200 copies/ml) levels.
|
Baseline to 12-months post intervention initiation
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anxiety
大体时间：Baseline to 24-months post intervention initiation
|
The GAD-7 is a standardized instrument that asks participants to rate their symptoms over the past two weeks on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day).
Overall scores for the GAD-7 range from 0 to 21.
At a cut-point of 10 (indicative of clinically significant symptoms), the sensitivity and specificity of the scale equals 89% and 82% respectively.
The GAD-7 has a Cronbach's of .92,
indicating good internal consistency with an intra-class correlation of .83,
indicating good procedural validity.
|
Baseline to 24-months post intervention initiation
|
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Adherence measurement
大体时间：Baseline to 24 months post-intervention initiation
|
The three-item Self-reported ART adherence measure used in prior Suubi studies
|
Baseline to 24 months post-intervention initiation
|
|
General functioning
大体时间：Baseline to 24 months post-intervention initiation
|
Children's Global Assessment Scale (CGAS)136, an adaptation of the Global Assessment Scale for adults, young people scored between 1 to 100, with 10 categories.
Participants with CGAS score of 1-10 needs constant supervision, with scores of 91-100 means superior functioning.
CGAS can be a useful measure of overall severity of disturbance.
It was found to have moderate to good reliability between raters and across time, as measured by intraclass correlation
|
Baseline to 24 months post-intervention initiation
|
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。
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 (估计的)
2026年12月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2030年8月1日
研究注册日期
首次提交
2026年6月4日
首先提交符合 QC 标准的
2026年6月4日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年6月9日
上次提交的符合 QC 标准的更新
2026年6月4日
最后验证
2026年6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.