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Background Perinatal women living with HIV (PWLH) have a greater risk of depression compared to other women; however, there are limited specialized mental health services available to them. We aimed to determine whether a stepped-care intervention facilitated by trained lay providers can improve mental health outcomes postpartum for PWLH. Methods and findings Healthy Options is a cluster-randomized controlled study conducted in 16 government-managed antenatal care clinics that provided HIV care for pregnant women in urban Tanzania. Recruitment occurred from May 2015 through April 2016, with the final round of data collection completed in October 2017. Participants included a consecutive sample of pregnant women under 30 weeks of gestation, living with HIV and depression, and attending the study clinics. Control sites received enhanced usual care for depression (EUDC). Intervention sites received EUDC plus the Healthy Options intervention, which includes prenatal group sessions of problem-solving therapy (PST) plus cognitive behavioral therapy (CBT) sessions for individuals showing depressive symptoms at 6 weeks postdelivery. We assessed depressive symptoms comparable to major depressive disorder (MDD) using the Patient Health Questionnaire-9 (PHQ-9) with a locally validated cutoff at 9 months and 6 weeks postpartum. The primary time point is 9 months postpartum. We examined differences in outcomes using an intent-to-treat analysis with a complete case approach, meaning those with data at the relevant time point were included in the analysis. We used generalized estimating equations accounting for clustering. Of 818 women screened using the PHQ-9, 742 were determined eligible and enrolled (395 intervention; 347 control); 649 women (87.5%) participated in the first follow-up and 641 women (86.4%) in the second. A majority (270, 74.6%) of women in the intervention arm attended 5 or more PST sessions. Women enrolled in Healthy Options demonstrated a 67% (RR 0.33; 95% CI: 0.22, 0.51; p-value: Conclusions The Healthy Options intervention did not demonstrate reduction in depressive symptoms at 9 months postpartum, the primary outcome. Significant reductions were seen in depression symptoms at 6 weeks postpartum, the secondary outcome. Stepped-care interventions may be relevant for improving outcomes in the critical early postpartum window. Trial registration Clinical Trial registration number (closed to new participants) NCT02039973 Elysia Larson and colleagues report the results of a cluster-randomized trial from Tanzania which investigates the impact of a peer-facilitated psychological intervention for perinatal women living with HIV and depression. Author summary Why was this study done? Depression during the pregnancy and postpartum periods is common, particularly among women living with HIV. In many resource-limited areas, availability of specialized mental health services is inadequate. Models of effective lay health worker-facilitated psychological interventions are needed to fill the care gap. What did the researchers do and find? A cluster-randomized controlled trial was conducted in 16 government-managed health clinics in urban Tanzania to examine the impact of a community-based health worker (CBHW)-led group intervention on symptoms of depression in the postpartum period. The stepped-care intervention included problem-solving therapy (PST) provided to all enrolled participants during pregnancy plus cognitive behavioral therapy (CBT) provided to participants who still showed symptoms of depression postpartum. At 9 months postpartum, the intervention group did not have a significant reduction in depressive symptoms compared to the enhanced control group. There was a 67% reduction in the likelihood of symptoms of depression at 6 weeks postpartum in the intervention group compared to the control group. What do these findings mean? The stepped-care model tested here was not effective in reducing symptoms of depression at 9 months postpartum, but was at 6 weeks postpartum. Additional interventions in the postpartum period need to be explored to significantly reduce symptoms of depression among pregnant women living with HIV in the longer term.

Abstract Background Perinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; however, in Tanzania there is limited access to services provided by mental health professionals. This paper presents a protocol and baseline characteristics for a study evaluating a psychosocial support group intervention facilitated by lay community-based health workers (CBHWs) for perinatal women living with HIV and depression in Dar es Salaam. Methods A cluster randomized controlled trial (RCT) is conducted comparing: 1) a psychosocial support group intervention; and 2) improved standard of mental health care. The study is implemented in reproductive and child health (RCH) centers providing PMTCT services. Baseline characteristics are presented by comparing sociodemographic characteristics and primary as well as secondary outcomes for the trial for intervention and control groups. The trial is registered under clinicaltrials.gov (NCT02039973). Results Among 742 women enrolled, baseline characteristics were comparable for intervention and control groups, although more women in the control group had completed secondary school (25.2% versus 18.2%). Overall, findings suggest that the population is highly vulnerable with over 45% demonstrating food insecurity and 17% reporting intimate partner violence in the past 6 months. Conclusions Baseline characteristics for the cluster RCT were comparable for intervention and control groups. The trial will examine the effectiveness of a psychosocial support group intervention for the treatment of depression among women living with HIV accessing PMTCT services. A reduction in the burden of depression in this vulnerable population has implications in the short-term for improved HIV-related outcomes and for potential long-term effects on child growth and development. Trial registration The trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.