Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa: a Pragmatic Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,002
- 试验地点
- 3
- 主要终点
- Viral load suppression
研究概览
简要总结
With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned from a terminal illness to a long-term condition. It is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the HIV itself, as well as adverse effects of medication. This requires an expansion of the purview of HIV care beyond direct HIV clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public sector primary care clinics in the North West Province of SA. It will assess mental health and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •40 nurse-led primary care clinics providing ART in the Dr Kenneth Kaunda and Bojonala districts of the North West Province, South Africa
- •Age ≥ 18 years and
- •Receiving ART at the time of enrollment and
- •Depressive symptoms, as indicated by a total score of 9 or more on the PHQ-9 and
- •Planning to reside in the area for the next year and
- •Capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, six and twelve months later and
- •Written consent to participate in the study
排除标准
- •Clinics which participate in the formative research and piloting of the intervention
- •Inability to meet the above inclusion criteria
结局指标
主要结局
Viral load suppression
时间窗: 12 months
viral load value of \<1000 RNA copies/ml
Patient Health Questionnaire 9 (PHQ-9) response
时间窗: 6 months
At least 50% improvement in PHQ-9 score compared with baseline
次要结局
- PHQ-9 Response at 12 months(12 months)
- Depression Remission at 12 months(12 months)
- Mean PHQ-9 score at 6 and 12 months(6 and 12 months)
- Antiretroviral therapy programme retention(12 months)
- Viral load suppression at 12 months(12 months)
- Virological failure(12 months)
- Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line(12 months)
- ART adherence(12 months)
- Change in viral load values over time(12 months)
- Depression severity (categorised as mild, moderate, moderately severe or severe depression at 6 and 12 months)(6 and 12 months)
- Antidepressant treatment initiated or intensified(12 months)
- Counselling for depression by a clinic-based counsellor(12 months)
- Referral to specialist mental health worker/service(12 months)
- Hospital admissions(12 months)
- Mortality(12 months)
- Stress(12 months)
- Risk factors for cardiovascular diseases(12 months)
- Detection and treatment of other chronic diseases(12 months)
- Stigma(12 months)
- Provision of integrated care from patient perspective(12 months)
研究者
Babalwa Zani
www.knowledgetranslation.co.za
University of Cape Town