Maternal depression treatment in HIV (M-DEPTH) Study protocol for a cluster randomized controlled trial
Loading...
Date
2019
Journal Title
Journal ISSN
Volume Title
Publisher
Medicine
Abstract
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 costeffective,
this study will provide a model for integrating depression care into ANC clinics and promoting adherence to PMTCT.
Description
Keywords
ART, Depression, HIV, Mental health, PMTCT, Pregnancy, Uganda
Citation
Wagner, G. J., McBain, R. K., Akena, D., Ngo, V., Nakigudde, J., Nakku, J., ... & Wanyenze, R. K. (2019). Maternal depression treatment in HIV (M-DEPTH): study protocol for a cluster randomized controlled trial. Medicine, 98(27). http://dx.doi.org/10.1097/MD.0000000000016329