Maternal depression treatment in HIV (M-DEPTH): Study protocol for a cluster randomized controlled trial

INTRODUCTION: Over one-third of human immunodeficiency virus (HIV)-infected pregnant women are clinically depressed, increasing the risk of mother-to-child transmission (MTCT) of HIV, as well as negative birth and child development outcomes. This study will evaluate the efficacy and cost-effectiveness of an evidence-based stepped care treatment model for perinatal depression (maternal depression treatment in HIV [M-DEPTH]) to improve adherence to prevention of MTCT care among HIV+ women in Uganda. METHODS: Eight antenatal care (ANC) clinics in Uganda will be randomized to implement either M-DEPTH (n=4) or usual care (n=4) for perinatal depression among 400 pregnant women (n=50 per clinic) between June 2019 and August 2022. At each site, women who screen positive for potential depression will be enrolled and followed for 18 months post-delivery, assessed in 6-month intervals: baseline, within 1 month of child delivery or pregnancy termination, and months 6, 12, and 18 following delivery. Primary outcomes include adherence to the prevention of mother-to-child transmission (PMTCT) care continuum—including maternal antiretroviral therapy and infant antiretrovial prophylaxis, and maternal virologic suppression; while secondary outcomes will include infant HIV status, post-natal maternal and child health outcomes, and depression treatment uptake and response. Repeated-measures multivariable regression analyses will be conducted to compare outcomes between M-DEPTH and usual care, using 2-tailed tests and an alpha cut-off of P <.05. Using a micro-costing approach, the research team will relate costs to outcomes, examining the incremental cost-effectiveness ration (ICER) of M-DEPTH relative to care as usual. DISCUSSION: This cluster randomized controlled trial will be one of the first to compare the effects of an evidence-based depression care model versus usual care on adherence to each step of the PMTCT care continuum. If determined to be efficacious and cost-effective, this study will provide a model for integrating depression care into ANC clinics and promoting adherence to PMTCT. TRIAL REGISTRATION: NIH Clinical Trial Registry NCT03892915 (clinicaltrials.gov).