Economic and relationship-strengthening intervention to reduce alcohol use in couples living with HIV in Malawi: a study protocol for a randomised controlled trial of Mlambe.

introductionHeavy alcohol use has the potential to derail progress towards UNAIDS 95-95-95 targets for countries in sub-Saharan Africa (SSA). Within couples, alcohol use is closely linked with factors such as intimate partner violence and economic insecurity and can result in poor adherence to antiretroviral therapy (ART) and HIV clinical outcomes. We hypothesise that a combined economic and relationship intervention for couples that builds on the prior success of standalone economic and relationship-strengthening interventions will be efficacious for improving HIV clinical outcomes and reducing alcohol use. The synergy of these interventions has not been assessed in SSA-specifically among people living with HIV who drink alcohol. To test this hypothesis, we will test METHODS AND ANALYSIS: We will enrol 250 adult married couples having at least one partner living with HIV and reporting heavy alcohol use. There will be two arms: ETHICS AND DISSEMINATION: The RCT has been approved by the University of California, San Francisco (UCSF) (Human Research Protection Program; Protocol Number 23-40642), and the study has been approved by the National Health Sciences Research Committee (NHSRC; Protocol Number 24/05/4431) in Malawi. Adverse events and remedial actions will be reported to authorities both in Malawi and at UCSF. Results will be disseminated to study participants, local health officials and HIV policy makers and through presentations at conferences and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Protocol Registration; NCT06367348 registered on 19 April 2024; https://register. CLINICALTRIALS: gov/. Protocol Version 1.0: 22 October 2024.