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

Area of Science:

• Public Health
• Mental Health
• Infectious Disease Epidemiology

Background:

• Perinatal depression affects over one-third of HIV-infected pregnant women, increasing HIV mother-to-child transmission (MTCT) risk and adverse birth outcomes.
• Integrating mental health support into antenatal care is crucial for improving maternal and child health in HIV-positive populations.

Purpose of the Study:

• To evaluate the efficacy and cost-effectiveness of the maternal depression treatment in HIV (M-DEPTH) model.
• To assess M-DEPTH's impact on adherence to the prevention of mother-to-child transmission (PMTCT) care continuum among HIV-positive pregnant women in Uganda.

Main Methods:

• A cluster randomized controlled trial involving 400 pregnant women across 8 antenatal care (ANC) clinics in Uganda.
• Clinics randomized to M-DEPTH or usual care; participants followed for 18 months post-delivery, with assessments at 6-month intervals.
• Primary outcomes: adherence to PMTCT continuum (maternal ART, infant prophylaxis, viral suppression); secondary outcomes: infant HIV status, maternal/child health, depression treatment response.

Main Results:

• The study is ongoing; results are pending.
• Analysis will compare PMTCT adherence and health outcomes between M-DEPTH and usual care groups using multivariable regression.
• Cost-effectiveness will be assessed using a micro-costing approach and incremental cost-effectiveness ratio (ICER).

Conclusions:

• This trial is among the first to compare a structured depression care model with usual care for PMTCT adherence.
• Positive findings could support integrating M-DEPTH into routine ANC services to enhance PMTCT and maternal/child well-being.
• The study aims to establish a scalable model for perinatal depression management in HIV-infected women.