Study Design
depression, abortion
MISCARRIAGE, BLIND
This is a prospective, multi-site cluster randomized controlled trial to evaluate the effects of an evidence-based, collaborative care model of depression care, relative to usual care, on PMTCT adherence and outcomes. The study is being performed at eight ANC clinics in Uganda, with four clinics randomly assigned (using a computer-generated list of assignments) to implement the intervention in addition to usual care, and four clinics to implement usual care alone. Randomization was stratified by level of facility (larger regional hospital and smaller health center IVs), which differ primarily by size of clientele, as the ANC and mental health services are comparable across all sites, as is staff composition. To ensure balance on this factor, clinics were randomized such that one regional hospital and three health center IVs (HCIV) were assigned to each of the intervention and control arms. Providers, participants, and data collectors were unblinded to the assignment of treatment condition; only the data analyst was blind. Participants were followed through completion of pregnancy and until 18-month post-partum (six months for women who had a miscarriage, abortion, or still-birth), with assessments at baseline and 2, 6, 12 and 18 months post pregnancy completion; however, only data from the baseline and 2-month post-pregnancy completion (PP) assessments have been fully collected and thus included in this analysis. The study protocol was reviewed and approved by institutional review boards at RAND and Makerere University School of Public Health, and the Uganda National Council for Science and Technology.