Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- Depression symptoms, 3 months
研究概览
简要总结
Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. Lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in ART. As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care, and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.
The investigators will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9). Rollout will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g. HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every three months through 12-month follow-up. The investigators will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model.
This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. The investigators will also look at the indirect effects of the intervention at the household level. The investigators' hypothesis is that the intervention will be effective at reducing depression symptoms, improving physical health, and improving household members' wellbeing, compare to treatment as usual. The investigators also hypothesize that the intervention will be highly cost-effective, meaning that the cost per QALY gained will be less than Malawi's median GDP per capita. If determined to be effective and cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.
详细描述
BACKGROUND
Major depressive disorder imposes catastrophic health and economic impacts in Malawi, and throughout sub-Saharan Africa. Depression is a leading cause of disability in Malawi. Yet, best evidence suggests that over 90% of individuals with the condition receive no treatment (1). The cost of inaction is liable to have wide-ranging impacts. In terms of health, depression-when untreated-typically observes a recurrent trajectory across the lifespan, and is associated with significant depreciation in quality of life. Depression also indirectly impacts other health outcomes, including HIV outcomes such as adherence to antiretroviral therapy and health-seeking behavior. In terms of social ecology, depression affects interpersonal relationships, engagement in household activities, and labor force participation. The World Economic Forum has estimated a $30 trillion loss over a twenty-year span due to neglected treatment of neuropsychiatric conditions, largely due to lost labor force participation (2).
Integrating depression care into Neno's HIV platform represents a cost-effective, scalable solution in Neno District, Malawi, consistent with best practices. Over the past 10 years, Malawi has enrolled over a million individuals in antiretroviral therapy. Current enrollment levels stand at 580,000. This has been achieved by introducing a framework of HIV care delivery, the basis of which is a network of 706 HIV clinics throughout the country. Over this same timeframe, HIV has evolved from an acute condition with poor prognosis, to a chronic condition with vastly improved survival rates. Given this context, the HIV system is a strategic point of entry for screening and treating depression, as it represents a leveragable chronic care system. In Neno District, HIV facilities have already transitioned into an integrated chronic care platform for treating conditions like diabetes, hypertension, asthma and epilepsy. Likewise, community health screenings, routine in Malawi, could be leveraged to screen for depression.
Overarching Objective. Evaluate a clinical model of screening and treatment for depression in terms of 'real world' effectiveness and cost-effectiveness at reducing depression in Neno District.
Objective 1. Determine the implementation strategy effectiveness-in terms of improved depression (PHQ-9), daily functioning (WHODAS), and overall health (EQ5D)-of introducing a stepped model of depression care (behavioral therapy and antidepressant therapy) among adults receiving integrated chronic care in Neno District, Malawi between July 1, 2021-June 30, 2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Those who are screening and diagnosing depression will not be made aware of the randomization sequence. Likewise, those assessing outcomes will not be made aware of the randomization sequence.
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
- •Attendance at integrated chronic care centers (IC3) in Neno District, Malawi
- •Adult, age 18 or older
排除标准
- •Psychosis, or indication of other Axis I psychiatric illness
研究组 & 干预措施
Cluster 1 (First Cluster of Clinics Randomized to Receive Care)
Arm 1 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 3 of the trial
干预措施: Problem Management Plus (Behavioral)
Cluster 5 (Fifth Cluster of Clinics Randomized to Receive Care)
Arm 5 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 15 of the trial
干预措施: Problem Management Plus (Behavioral)
Cluster 1 (First Cluster of Clinics Randomized to Receive Care)
Arm 1 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 3 of the trial
干预措施: Antidepressant Therapy (Drug)
Cluster 2 (Second Cluster of Clinics Randomized to Receive Care)
Arm 2 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 6 of the trial
干预措施: Problem Management Plus (Behavioral)
Cluster 2 (Second Cluster of Clinics Randomized to Receive Care)
Arm 2 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 6 of the trial
干预措施: Antidepressant Therapy (Drug)
Cluster 3 (Third Cluster of Clinics Randomized to Receive Care)
Arm 3 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 9 of the trial
干预措施: Problem Management Plus (Behavioral)
Cluster 3 (Third Cluster of Clinics Randomized to Receive Care)
Arm 3 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 9 of the trial
干预措施: Antidepressant Therapy (Drug)
Cluster 4 (Fourth Cluster of Clinics Randomized to Receive Care)
Arm 4 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 12 of the trial
干预措施: Problem Management Plus (Behavioral)
Cluster 4 (Fourth Cluster of Clinics Randomized to Receive Care)
Arm 4 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 12 of the trial
干预措施: Antidepressant Therapy (Drug)
Cluster 5 (Fifth Cluster of Clinics Randomized to Receive Care)
Arm 5 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 15 of the trial
干预措施: Antidepressant Therapy (Drug)
结局指标
主要结局
Depression symptoms, 3 months
时间窗: 3 months
Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as change in PHQ-9 score from baseline (pre-intervention) to 3-months (post-intervention).
Depression symptoms, 6 months
时间窗: 6 months
Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as change in PHQ-9 score from baseline (pre-intervention) to 6-months (post-intervention).
Depression symptoms, 9 months
时间窗: 9 months
Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as change in PHQ-9 score from baseline (pre-intervention) to 9-months (post-intervention).
Depression symptoms, 12 months
时间窗: 12 months
Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as change in PHQ-9 score from baseline (pre-intervention) to 12-months (post-intervention).
Functional impairment, 3 months
时间窗: 3 months
Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as change in WHODAS score from baseline (pre-intervention) to 3-months (post-intervention).
Functional impairment, 6 months
时间窗: 6 months
Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as change in WHODAS score from baseline (pre-intervention) to 6-months (post-intervention).
Functional impairment, 9 months
时间窗: 9 months
Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as change in WHODAS score from baseline (pre-intervention) to 9-months (post-intervention).
Functional impairment, 12 months
时间窗: 12 months
Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as change in WHODAS score from baseline (pre-intervention) to 12-months (post-intervention).
Overall health profile, 3 months
时间窗: 3 months
A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as change in EQ-5D-5L score from baseline (pre-intervention) to 3-months (post-intervention).
Overall health profile, 6 months
时间窗: 6 months
A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as change in EQ-5D-5L score from baseline (pre-intervention) to 6-months (post-intervention).
Overall health profile, 9 months
时间窗: 9 months
A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as change in EQ-5D-5L score from baseline (pre-intervention) to 9-months (post-intervention).
Overall health profile, 12 months
时间窗: 12 months
A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as change in EQ-5D-5L score from baseline (pre-intervention) to 12-months (post-intervention).
Depression prevalence, 3 months
时间窗: 3 months
Depression prevalence will be quantified as the change in proportion of individuals with moderate-to-severe depression (PHQ-9\>9) at each clinic from baseline (pre-intervention) to 3-months (post-intervention).
Depression prevalence, 6 months
时间窗: 6 months
Depression prevalence will be quantified as the change in proportion of individuals with moderate-to-severe depression (PHQ-9\>9) at each clinic from baseline (pre-intervention) to 6-months (post-intervention).
Depression prevalence, 9 months
时间窗: 9 months
Depression prevalence will be quantified as the change in proportion of individuals with moderate-to-severe depression (PHQ-9\>9) at each clinic from baseline (pre-intervention) to 9-months (post-intervention).
Depression prevalence, 12 months
时间窗: 12 months
Depression prevalence will be quantified as the change in proportion of individuals with moderate-to-severe depression (PHQ-9\>9) at each clinic from baseline (pre-intervention) to 12-months (post-intervention).
次要结局
- A1C levels among diabetic patients, 12 months(12 months)
- Number of seizures among patients with epilepsy, 3 months(3 months)
- Number of seizures among patients with epilepsy, 6 months(6 months)
- ART Adherence, 3 months(3 months)
- ART Adherence, 6 months(6 months)
- ART Adherence, 9 months(9 months)
- ART Adherence, 12 months(12 months)
- Viral suppression among HIV+ patients, 3 months(3 months)
- Viral suppression among HIV+ patients, 6 months(6 months)
- Viral suppression among HIV+ patients, 9 months(9 months)
- Viral suppression among HIV+ patients, 12 months(12 months)
- HIV disease staging among HIV+ patients, 3 months(3 months)
- HIV disease staging among HIV+ patients, 9 months(9 months)
- HIV disease staging among HIV+ patients, 12 months(12 months)
- Systolic blood pressure among hypertensive patients, 3 months(3 months)
- Systolic blood pressure among hypertensive patients, 6 months(6 months)
- Systolic blood pressure among hypertensive patients, 9 months(9 months)
- Systolic blood pressure among hypertensive patients, 12 months(12 months)
- A1C levels among diabetic patients, 3 months(3 months)
- HIV disease staging among HIV+ patients, 6 months(6 months)
- A1C levels among diabetic patients, 6 months(6 months)
- A1C levels among diabetic patients, 9 months(9 months)
- Number of seizures among patients with epilepsy, 12 months(12 months)
- Number of seizures among patients with epilepsy, 9 months(9 months)