Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda (INDEPTH-Uganda)
2015年10月2日 更新者:Glenn Wagner、RAND
Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits
This study compares two models for implementing antidepressant treatment in 10 HIV clinics in Uganda.
Using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen.
The protocolized model includes (1) routine depression screening at each clinic visit for all adult patients by trained expert patients at triage, (2) training nurses to diagnose depression and prescribe and monitor antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and monitoring by hired study psychiatrists.
The clinical acumen model also includes routine depression screening and ongoing supervision, but it relies on the clinical acumen of trained primary care providers to further evaluate and treat patients who show signs of depression at screening, as opposed to a structured protocol.
The primary aim is to test the hypothesis that the nurse-driven protocolized model will result in greater uptake of antidepressant treatment and better quality of depression care outcomes.
The study will also test the hypotheses that treatment of depression results in improved HIV treatment adherence, work functioning and consistent condom use.
研究概览
详细说明
The study evaluates a task-shifting approach to depression treatment that uses an algorithm-based, nurse-driven model for managing antidepressant treatment in 10 Ugandan HIV clinics.
The model will include (1) case identification facilitated by routine depression screening at each clinic visit for all patients, (2) training nurses to assist primary care providers in implementing antidepressant treatment by performing the initial evaluation, monitoring symptoms and side effects, and making algorithm-based dose recommendations, and (3) layers of supervision and monitoring by psychiatric specialists to ensure safety and quality of care.
This model will be implemented at 5 randomly selected clinics (protocolized arm), while 5 other clinics will be selected to also use routine depression screening but will rely on primary care providers to decide whether to further evaluate and treat depression (clinical acumen arm).
At each site, random samples of 150 patients (total n=1500) who have screened positive for possible depression will be followed for 12 months.
We will compare the two arms on depression evaluation, uptake of antidepressant treatment, and change in depression (treatment response).
We will also examine the relationship between change in depression and key economic and public health outcomes (e.g.
work status, condom use, HIV treatment adherence).
研究类型
介入性
注册 (实际的)
1252
阶段
- 第四阶段
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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Wakiso, Mpigi, Luwero, Mityana districts、乌干达
- health care facilities receiving technical assistance from Mildmay Uganda
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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 至 65年 (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
Inclusion Criteria:
- age 18 years or above
- screens positive for depression (scores > 2 on PHQ-2)
- medically stable
- client at the HIV clinic (and hence, HIV positive)
Exclusion Criteria:
- active acute opportunistic infection
- about to start HIV antiretroviral therapy or started antiretroviral therapy within past 4 weeks
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Clinical acumen
Depression diagnosis and antidepressant treatment provided based on clinical acumen of primary care providers trained to provide depression care.
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有源比较器:Protocolized Arm
Structured, algorithm-based protocol that guides depression diagnosis and antidepressant treatment
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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 |
---|---|---|
Depression diagnostic evaluation
大体时间:baseline, Month 6, Month 12
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Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression
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baseline, Month 6, Month 12
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Antidepressant prescription
大体时间:baseline, Month 6, Month 12
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Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 > 9
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baseline, Month 6, Month 12
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Depressive symptoms
大体时间:past 2 weeks at Month 6 and Month 12
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depressive symptoms present at Month 6 and Month 12 (in comparison to baseline) to assess treatment response; PHQ-9 will be used to measure depressive symptoms
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past 2 weeks at Month 6 and Month 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Consistent condom use
大体时间:past 6 months prior to baseline, Month 6, Month 12
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A single likert scale item will be used to assess condom use in the past month; a single item will also be used to assess whether condom was used during last event of sexual intercourse
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past 6 months prior to baseline, Month 6, Month 12
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ART adherence
大体时间:past month prior to baseline, Month 6 and Month 12
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single variable to rate adherence to ART over the past month on scale of 0-100
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past month prior to baseline, Month 6 and Month 12
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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
调查人员
- 首席研究员:Glenn Wagner, PhD、RAND
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
- Wagner GJ, Ngo V, Goutam P, Glick P, Musisi S, Akena D. A Structured Protocol Model of Depression Care versus Clinical Acumen: A Cluster Randomized Trial of the Effects on Depression Screening, Diagnostic Evaluation, and Treatment Uptake in Ugandan HIV Clinics. PLoS One. 2016 May 11;11(5):e0153132. doi: 10.1371/journal.pone.0153132. eCollection 2016.
- Wagner GJ, Ngo V, Glick P, Obuku EA, Musisi S, Akena D. INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial. Trials. 2014 Jun 25;15:248. doi: 10.1186/1745-6215-15-248.
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
2013年1月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2014年2月3日
首先提交符合 QC 标准的
2014年2月4日
首次发布 (估计)
2014年2月5日
研究记录更新
最后更新发布 (估计)
2015年10月5日
上次提交的符合 QC 标准的更新
2015年10月2日
最后验证
2015年10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.
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