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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).

Background Literature shows a high prevalence of psychological distress (PD) as well as common mental disorders (CMD) such as major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress disorders (PTSD), and substance misuse disorders (SUD) among people exposed to disasters and pandemics like the COVID-19. Moreover, CMD are associated with increased mortality (mainly through suicide) and morbidity (loss of productivity). A number of countries have made deliberate efforts to identify and manage CMD in light of COVID-19. However, low levels of mental health literacy (MHL) manifested by the individual’s unawareness of CMD symptoms, limited human and mental health infrastructure resources, and high levels of mental illness stigma (MIS) are barriers to integration of mental health care in general health care during pandemics and epidemics such as the COVID-19. Objectives For the proposed study, we will determine effectiveness of a psycho-education intervention delivered by village health team (VHT) members. Methods We will employ a cluster randomized trial design in 24 villages in central Uganda. We will collect baseline data to and document the prevalence of MHL, PD, MDD, PTSD, GAD, and SUD. We will distribute information education and communication materials (IEC) aimed at improving MHL to 420 adult individuals in the intervention arm (n = 12 villages). In the control arm (n = 12 villages), VHTs will distribute ministry of health COVID-19 information leaflets to 420 participants. Within 7 days of distributing the materials, research assistants will conduct a follow-up interview and assess for the same parameters (MHL, PD, MDD, PTSD, GAD, and SUD). We will use an intention to treat analysis to estimate the effectiveness of the psycho-education intervention. Discussion Findings from this research will guide policy and practice regarding the integration of mental health services in the community in the context of epidemic preparedness and response. Trial registration ClinicalTrials.govNCT04616989. Registered on 05 November 2020

BackgroundMental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.Methods/designWe will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale –up.DiscussionThe results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information – a critical gap for addressing a leading global cause of disability.Trial registrationClinicalTrials.gov NCT03466346, registered March 15, 2018.