Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform

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.

Timeline

Start

2021-09-01

Primary completion

2023-04-30

Completion

2025-06-30

Publications

• Background Udedi M. The prevalence of depression among patients and its detection by primary health care workers at Matawale Health Centre (Zomba). Malawi Med J. 2014 Jun;26(2):34-7.
• Background World Economic Forum. The Global Economic Burden of Non-Communicable Diseases. World Economic Forum; Harvard School of Public Health; 2011.
• Background Passchier RV, Abas MA, Ebuenyi ID, Pariante CM. Effectiveness of depression interventions for people living with HIV in Sub-Saharan Africa: A systematic review & meta-analysis of psychological & immunological outcomes. Brain Behav Immun. 2018 Oct;73:261-273. doi: 10.1016/j.bbi.2018.05.010. Epub 2018 May 13.
• Background McBain RK, Salhi C, Hann K, Kellie J, Kamara A, Salomon JA, Kim JJ, Betancourt TS. Improving outcomes for caregivers through treatment of young people affected by war: a randomized controlled trial in Sierra Leone. Bull World Health Organ. 2015 Dec 1;93(12):834-41. doi: 10.2471/BLT.14.139105. Epub 2015 Oct 16.
• Background Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
• Background Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Kamwiyo M, Mwale O, Mpinga K, Kayira W, Johnson I, Ruderman T, Matanje B, Kasambara K, Houde A, Isaacs R, Needham C, Wagner G, Kulisewa K, Udedi M, McBain RK. Provider perceptions and experiences integrating depression treatment into chronic healthcare services in Neno District, Malawi: a qualitative study. BMC Health Serv Res. 2025 Dec 10;26(1):66. doi: 10.1186/s12913-025-13830-2.
• Mwale O, Mpinga K, Rukundo T, Kamwiyo M, Kayira W, Matanje B, Munyaneza F, Ruderman T, Raviola G, Smith S, Okunogbe A, Kachimanga C, McBain RK. Cost analysis of integrating depression treatment into chronic care in Malawi: evidence from a cluster randomised controlled trial. BMJ Open. 2025 Oct 7;15(10):e095494. doi: 10.1136/bmjopen-2024-095494.
• Mwale O, Kasambala C, Houde A, Mpinga K, Kayira W, Harawa M, Kamwiyo M, Isaacs R, Nhlema B, Ruderman T, Liwimbi O, Udedi M, Kelly K, McBain RK. Patient perspectives on group problem management plus for adults with major depressive disorder in rural Malawi. Glob Health Action. 2025 Dec;18(1):2500785. doi: 10.1080/16549716.2025.2500785. Epub 2025 May 9.
• McBain RK, Mwale O, Mpinga K, Kamwiyo M, Kayira W, Ruderman T, Connolly E, Watson SI, Wroe EB, Munyaneza F, Dullie L, Raviola G, Smith SL, Kulisewa K, Udedi M, Patel V, Wagner GJ. Effectiveness, cost-effectiveness, and positive externalities of integrated chronic care for adults with major depressive disorder in Malawi (IC3D): a stepped-wedge, cluster-randomised, controlled trial. Lancet. 2024 Nov 9;404(10465):1823-1834. doi: 10.1016/S0140-6736(24)01809-9. Epub 2024 Oct 30.
• Mpinga K, Rukundo T, Mwale O, Kamwiyo M, Thengo L, Ruderman T, Matanje B, Munyaneza F, Connolly E, Kulisewa K, Udedi M, Kachimanga C, Dullie L, McBain R. Depressive disorder at the household level: prevalence and correlates of depressive symptoms among household members. Glob Health Action. 2023 Dec 31;16(1):2241808. doi: 10.1080/16549716.2023.2241808.
• Mpinga K, Lee SD, Mwale O, Kamwiyo M, Nyirongo R, Ruderman T, Connolly E, Kayira W, Munyaneza F, Matanje B, Kachimanga C, Zaniku HR, Kulisewa K, Udedi M, Wagner G, McBain R. Prevalence and correlates of internalized stigma among adults with HIV and major depressive disorder in rural Malawi. AIDS Care. 2023 Nov;35(11):1775-1785. doi: 10.1080/09540121.2023.2195609. Epub 2023 Mar 31.
• McBain RK, Mwale O, Ruderman T, Kayira W, Connolly E, Chalamanda M, Kachimanga C, Khongo BD, Wilson J, Wroe E, Raviola G, Smith S, Coleman S, Kelly K, Houde A, Tebeka MG, Watson S, Kulisewa K, Udedi M, Wagner G. Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial. Trials. 2021 Sep 16;22(1):630. doi: 10.1186/s13063-021-05601-1.

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