The TENDAI Study: Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Viral Suppression
研究概览
简要总结
A hybrid effectiveness-efficacy trial to evaluate a stepped care task shifted intervention to treat depression and HIV medication nonadherence in low resource settings in rural Zimbabwe.
详细描述
Depression is commonly co-morbid with HIV infection in Zimbabwe and is consistently associated with worse adherence to antiretroviral therapy (ART). A task-shifted intervention for depression and ART adherence, suitable for delivery by non-specialists, could make a critical difference to the health and survival of people managing the challenges of HIV treatment in Zimbabwe. The TENDAI trial is a two-arm randomized controlled trial of an intervention for people on ART with viral non-suppression and clinically significant depression. It will be delivered at an HIV clinic in Marondera. TENDAI is a collaboration between the Department of Psychiatry, University of Zimbabwe College of Health Sciences, King's College London Institute of Psychiatry, Psychology and Neuroscience (London UK), and the Department of Psychiatry at Massachusetts General Hospital / Harvard Medical School.
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
- •Initiated on ART for at least 6 months
- •Clinically significant depression symptoms scoring >/= 10 on the Patient Health Questionnaire-9
- •Viral non-suppression in past two months per local clinic standard (VL > 1000 copies/mL)
- •Able to provide informed consent
- •If prescribed antidepressants, on stable regimen for at least 2 months
排除标准
- •Unable to provide informed consent
- •Active major mental illness (e.g. untreated psychosis or mania, actively suicidal), major untreated or undertreated mental illness or advanced physical disease or severe cognitive impairment assessed using the psychosis module of the MINI, the PHQ-9, and the International HIV dementia Scale which would interfere with engagement in PST-AD
- •Has ever received PST or CBT for depression
- •Less than 18 years of age
研究组 & 干预措施
Stepped care for non-adherence and depression
Participants will be randomized approximately two weeks post-baseline. Those randomized to the experimental condition will receive the Intervention and Stepped Care Treatment Protocol
干预措施: Stepped care for nonadherence and depression (Behavioral)
Enhanced Usual Care
Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
Viral Suppression
时间窗: 12 - month post randomization study visit
Viral Suppression operationalized as proportion of participants who achieve viral suppression (\<1000 copies/mL)
次要结局
- Adherence to ART medication(8 month post randomization study visit)
- Depression severity(12-month post randomization study visit)
- Self-reported adherence to ART medication(8 month post randomization study visit)
- Viral load copies/mL(12-month post randomization study visit)
研究者
Dr Melanie Abas
Associate Professor in Global Mental Health
King's College London