Depression and ART Adherence in HIV+ Latinos
2018年3月15日 更新者：Jane Simoni、University of Washington
Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
The current HIV treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.
研究概览
详细说明
Additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (MedSignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a Spanish-language version.
Our hypotheses are grounded in a conceptual model proposing that the CBT-AD intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of HIV-1 RNA viral load and CD4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence.
Evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve HIV treatment outcomes and thwart the development and transmission of drug resistant virus.
研究类型
介入性
注册 (实际的)
40
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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Texas
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El Paso、Texas、美国、79925
- Centro de Salud Familiar La Fe CARE Center
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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
Inclusion Criteria:
- HIV+ participants (a) currently receiving HIV care at La Fe CARE Center (study site);
- 18 years of age or older;
- Latino (i.e., self-identified as being of Mexican heritage);
- English- or Spanish-speaking
- capable of giving informed consent;
- currently on a prescribed antiretroviral regimen;
- suboptimally adherent (i.e., demonstrated either by a VL load taken in the last 12 months that is above the undetectable threshold of 50 mL copies or self-reporting a missed dose in the last two weeks);
- exhibiting some depressive symptomatology (i.e., scoring on the Beck Depression Inventory-1A 10 or above), and (i) male or female (including transgender Female-to-Male and Male-To-Female.
Exclusion Criteria:
- actively psychotic or so cognitively impaired that they cannot participate,
- so physically ill as to be unable to come to the clinic to participate in the intervention, OR
- Report The use of crack, cocaine, heroin, OR methamphetamines to any extent in the past 40 days.
- Those who are planning on being away from the area for any extended period during the study (as in the case of seasonal workers) or whom
- have household members already enrolled in the study will also be excluded. We did choose to restrict study eligibility to individuals of Mexican descent.
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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实验性的：Cognitive-Behavioral Therapy (CBT-AD)
This arm type is a cognitive-behavioral therapy program intervention for issues of medication adherence and depression.
The intervention is a therapy program intervention involves 10-weekly or biweekly sessions, with 2 booster session, and focused on psychoeducation, behavioral activation, cognitive restructuring, and problem-solving.
A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms.
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CBT-AD is a therapy program intervention that uses one-on-one and face-to-face patient-therapist sessions.
其他名称：
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无干预：Control-Standard Care
Those randomized to the control condition are not involved in the CBT-AD therapy intervention.
They receive standard care as usual.
A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms.
The participants in the control arm are followed and matched to a participant in the intervention arm.
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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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Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a
大体时间：MADRS and BDI-1a scores at 6 and 9-month follow-up
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MADRS and BDI-1a scores at 6 and 9-month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-Report Adherence
大体时间：Self-reported adherence at 6 and 9-month follow-up
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Self-reported adherence was assessed with the visual analog scale (VAS).
The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken.
Higher scores indicate better adherence.
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Self-reported adherence at 6 and 9-month follow-up
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MedSignals Electronic Pill-box for Adherence
大体时间：6 and 9 month follow-up adherence scores
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The MedSignals electronic pill-box is a storage bin that allows participants to store medications.
In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication.
The pill-box stores adherence data (time, number of openings).
In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise.
All data is uploaded electronically.
Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.
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6 and 9 month follow-up adherence scores
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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：Jane M Simoni, Ph.D.、University of Washington
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
2008年7月1日
初级完成 (实际的)
2011年8月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2011年7月25日
首先提交符合 QC 标准的
2011年8月5日
首次发布 (估计)
2011年8月8日
研究记录更新
最后更新发布 (实际的)
2018年3月19日
上次提交的符合 QC 标准的更新
2018年3月15日
最后验证
2018年3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.