Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

487

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Sep 2021

Longer than P75 for phase_4

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

February 23, 2021

Completed

7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed

6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed

Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

February 23, 2021

Last Update Submit

April 24, 2024

Conditions

Depressive Disorder

Keywords

depressionstepped carebehavioral therapyProblem Management Plusantidepressant therapy

Outcome Measures

Primary Outcomes (16)

Depression symptoms, 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).
3 months
Depression symptoms, 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).
6 months
Depression symptoms, 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).
9 months
Depression symptoms, 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).
12 months
Functional impairment, 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).
3 months
Functional impairment, 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).
6 months
Functional impairment, 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).
9 months
Functional impairment, 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).
12 months
Overall health profile, 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).
3 months
Overall health profile, 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).
6 months
Overall health profile, 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).
9 months
Overall health profile, 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).
12 months
Depression prevalence, 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).
3 months
Depression prevalence, 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).
6 months
Depression prevalence, 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).
9 months
Depression prevalence, 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).
12 months

Secondary Outcomes (24)

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
+19 more secondary outcomes

Other Outcomes (16)

Household member: burden of care
Pre-treatment (baseline) and 6-month follow-up
Household member: depression
Pre-treatment (baseline) and 6-month follow-up
Household member: functional impairment
Pre-treatment (baseline) and 6-month follow-up
+13 more other outcomes

Study Arms (5)

Cluster 1 (First Cluster of Clinics Randomized to Receive Care)

EXPERIMENTAL

Arm 1 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 3 of the trial