RCT to evaluate an intervention for depressed HIV-positive women in the perinatal period, to enhance child development and reduce maternal depression (360G-Wellcome-206005_Z_16_Z)

Rates of HIV are very high amongst pregnant women in parts of sub-Saharan Africa (SSA) with, for example rates of over 30% in antenatal clinics in South Africa1. Many receive their diagnosis during pregnancy as partof screening to prevent mother-to-child transmission (PMTCT). Depression is very common amongst these women, with up to 40% screening above the threshold for depression2, 3. Perinatal depression is associatedwith poor adherence to antiretroviral treatment (ART)4, 5, low clinic attendance, suicidal ideation6 and lowrates of breastfeeding7. Of major concern is the evidence of negative effects on fetal outcomes, children'sgrowth and cognitive development7. Improving the wellbeing of mothers and infants requires effectivetreatment of HIV and perinatal depression8. Although treatment of depression improves adherence to HIVtreatment by > 80% 5, there is no established effective treatment for perinatal depression in SSA for motherswith HIV. The aim of this study is to develop and test the feasibility and acceptability of a six-session intervention targeting perinatal depression in HIV-positive women. The intervention will utilise Behavioural Activation (BA), which has been shown to be as effective as Cognitive Behaviour Therapy (CBT) in high-income settings9. BA is much simpler than CBT to deliver, especially by non-specialist health workers withlimited training in under-resourced settings. This early phase study is needed to develop, standardise and pilot the BA intervention and test its feasibility. The study will provide treatment for 70 pregnant women and follow them to 3 months postnatally. The outcomes of the main study will include: maternal depression, child emotional and cognitive development and growth, adherence to ART, initiation and maintenance of breastfeeding, infant HIV testing and vaccinations. This work will be conducted at the Africa Centre for Health and Population Studies, a large demographic surveillance site in South Africa with a high HIV prevalence.