The Adaptation of a Stepped Care, Task-sharing Approach for Integrating Depression Care for Older People Living With HIV (PLHIV) Into HIV Treatment and Support Services in Ibadan, Nigeria.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effectiveness of a Stepped-Care Task-Sharing (SCT) Model in reducing depressive symptoms measured by PHQ-9.
研究概览
简要总结
Depression levels will be compared using PHQ-9 in the Treatment as Usual arm(TAU) VS intervention arm to see if the stepped care intervention is effective in treating depression. The main questions it aims to answer are:
- Needs assessment of stepped-care integration versus usual care for treating depression in older adults living with HIV?
- How effective will the stepped care task-sharing (SCT) model in reducing depressive symptoms and improving HIV treatment outcomes in older PLHIV in Nigeria? Participants who screen positive for depression PHQ-9 ≥10 will be randomized into 2 arms for treatment using a systemized ballot system: TAU arm and Intervention arm.
TAU arm will receive current treatment available for depression at the HIV center.
Intervention arm will receive the stepped-care intervention in stages based on their symptom severity.
Follow-up assessments at (6 weeks, 3months and 6 months) will be conducted by assessors who would be blinded to the different groups (TAU arm VS intervention arm).
详细描述
Depression is a common but often overlooked comorbidity among older adults living with HIV (PLHIV), particularly in low-resource settings. It negatively impacts health outcomes, adherence to antiretroviral therapy (ART), and overall quality of life. Despite its high prevalence, access to specialized mental health services remains limited due to workforce shortages and structural barriers within healthcare systems. A stepped-care task-sharing approach offers a potentially scalable solution by leveraging non-specialist healthcare workers to deliver evidence-based mental health interventions in a structured, stepwise manner. This study aims to evaluate the effectiveness of this approach in reducing depression among older PLHIV and assess its feasibility for broader implementation in Nigerian health facilities.
Study Objectives:
- Effectiveness Assessment: To determine whether integrating a stepped-care task-sharing approach into routine HIV care is more effective in reducing depression symptoms compared to usual treatment among older PLHIV.
- Implementation Feasibility: To identify facilitators and barriers to the successful adaptation and implementation of this intervention in local HIV facilities.
- Patient Outcomes & Treatment Pathways: To evaluate the impact of the intervention on depression severity using the Patient Health Questionnaire-9 (PHQ-9) and examine how patients progress through different treatment steps based on symptom severity.
Study Design & Methodology:
This is a randomized controlled trial (RCT) comparing a stepped-care task-sharing intervention to usual care in older PLHIV with depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting individuals living with HIV
- •People living with HIV who are 50 years and above (PLHIV aged ≥50 years)
- •Those with a score of ≥10 on the 9-item patient-health questionnaire (PHQ-9).
排除标准
- •• Older PLHIV will be assessed for the imminent risk of suicide and if there is an high risk, participant will be excluded.
- •Older PLHIV with severe cognitive impairment or diagnosed dementia that limits their ability to provide informed consent or complete study visits will be excluded.
- •Participants with comorbidities that can preclude the use of sertraline should be excluded.
结局指标
主要结局
Effectiveness of a Stepped-Care Task-Sharing (SCT) Model in reducing depressive symptoms measured by PHQ-9.
时间窗: Baseline PHQ-9 score (before intervention) Follow-up assessments at 6 weeks, 3 months, and 6 months
This outcome will determine whether the Stepped care task-sharing approach provides greater symptom relief compared to usual treatment and supports its potential integration into routine HIV treatment and support service.
次要结局
未报告次要终点
研究者
OLUFISAYO ELUGBADEBO
Dr
Royal Society of Tropical Medicine and Hygiene