Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 5
- 主要终点
- Depression scores as assessed by an independent (blind assessor) after intervention.
研究概览
简要总结
The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from first-line treatment. The CBT treatment will be compared to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described in study endpoints section below).
详细描述
Clinical Clinical depression is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Based on our prior work, and given that CBT is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who did not achieve viral suppression from their first line ART, and have a unipolar depressive mood disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-seropositive
- •Current diagnosis of depression
- •Did not attain viral suppression from first-line ARV per local clinic standard
排除标准
- •Unable or unwilling to provide informed consent.
- •Active untreated, major mental illness (untreated psychosis or mania) that would interfere with CBT-AD.
- •Has not received CBT for depression.
- •Less than 18 years of age.
结局指标
主要结局
Depression scores as assessed by an independent (blind assessor) after intervention.
时间窗: 4 month assessment
Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.
Changes in HIV medication adherence throughout intervention phase
时间窗: Assessed between baseline and the 4 month assessment
Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device
次要结局
- CD4(12-month assessment)
- HIV medication adherence over follow-up(Aggregate across 4,8, and 12-month assessment)
- Depression scores as assessed by an independent (blind assessor) over follow-up(Aggregate across 4,8, and 12-month assessment)
- HIV viral load(12-month assessment)
研究者
Steven Safren
Professor
University of Miami