Abstract:
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).
journal_name
Medicine (Baltimore)journal_title
Medicineauthors
Wagner GJ,McBain RK,Akena D,Ngo V,Nakigudde J,Nakku J,Chemusto H,Beyeza-Kashesya J,Gwokyalya V,Faherty LJ,Kyohangirwe L,Nabitaka LK,Lukwata H,Linnemayr S,Ghosh-Dastidar B,Businge J,Mukasa B,Wanyenze RKdoi
10.1097/MD.0000000000016329subject
Has Abstractpub_date
2019-07-01 00:00:00pages
e16329issue
27eissn
0025-7974issn
1536-5964pii
00005792-201907050-00095journal_volume
98pub_type
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