Couples problem-solving therapy for perinatal women living with HIV and male partners in Malawi: a study protocol for a pilot trial of Mphatso

BMJ Open. 2026 May 15;16(5):e115210. doi: 10.1136/bmjopen-2025-115210.

ABSTRACT

INTRODUCTION: Perinatal depression is a common, yet understudied, mental health disorder among women and contributes to poor engagement in prevention of mother-to-child transmission (PMTCT) of HIV in sub-Saharan Africa. Male partners are positioned to provide critical forms of social and economic support during pregnancy and postpartum, and also may contribute to women’s stress, depression and anxiety through intimate partner violence and withholding of social support. Despite the critical role of men in pregnancy outcomes and HIV prevention, few interventions have engaged men around women’s depressive symptoms, nutrition and health, and engagement in PMTCT. We will conduct a pilot trial of Mphatso, a couple-based intervention based on problem-solving therapy with couple relationship skills to reduce depressive symptoms in perinatal women, improve food insecurity and prevent HIV transmission to the infant.

METHODS AND ANALYSIS: We will employ a two-arm pilot randomised controlled trial in the Zomba district of Malawi to assess the feasibility and acceptability of Mphatso (meaning ‘gift’ or the child) and explore health impacts on depressive symptoms, PMTCT engagement and food insecurity. We will enrol 60 pregnant women in the second or third trimester who are living with HIV and meet criteria for probable depression based on the Edinburgh Postnatal Depression Scale and their male partners. Couples will be randomised to receive either five sessions of Mphatso (problem-management skills plus health education and relationship skills) or enhanced usual care. Feasibility and acceptability outcomes will include session attendance rates, satisfaction levels and retention at 3 months and 6 months postpartum. Exploratory analyses using regression models including time and treatment arm will be conducted to explore effects on the mothers’ and fathers’ depressive symptoms, adherence to PMTCT (antiretroviral therapy, nevirapine use, HIV testing and exclusive breastfeeding) and food insecurity.

ETHICS AND DISSEMINATION: The pilot trial has been approved by the University of California, San Francisco (Human Research Protection Program (HRPP); Protocol Number 23-40685), and the study has also been approved by the National Health Sciences Research Committee in Malawi (NHSRC; Protocol Number 24/05/4431). Results will be disseminated to study participants, health officials, policymakers, community leaders and care providers, as well as through presentations at conferences and publications in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT06659315.

PMID:42152436 | DOI:10.1136/bmjopen-2025-115210