An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: Study Protocol for the Insika Yomama Cluster Randomised Controlled Trial

Abstract

Background: The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experience perinatal depression. Perinatal depression is associated with negative effects on parenting and key domains of child development including cognitive, behavioural and growth, especially in socio-economically disadvantaged communities. Several studies have documented the benefits of psychological interventions for perinatal depression in low- and middle-income countries, but none have evaluated an integrated psychological and parenting intervention for HIV-positive women using task-sharing. This randomised controlled trial aims to evaluate the effect of a home-based intervention, combining a psychological treatment for depression and a parenting programme for perinatally depressed HIV-positive women. Methods: This study is a cluster-randomised controlled trial, consisting of 48-60 geospatial clusters. A total of 528 pregnant HIV-positive women aged ≥16 years who meet the criteria for depression on the Edinburgh Postnatal Depression Scale (EPDS, score ≥9)) are recruited from antenatal clinics in rural KwaZulu-Natal, South Africa. The geospatial clusters are randomised on an allocation ratio of 1:1 to either the intervention or Enhanced Standard of Care. The intervention group receives 10 home-based counselling sessions by a lay-counsellor (4 antenatal and 6 postnatal sessions) and a booster session at 16 months. The intervention combines Behavioural Activation for depression with a parenting programme, adapted from the UNICEF/WHO Care for Child Development programme. The ESoC group receives two antenatal and two postnatal support and advice telephone calls. The co-primary outcomes are child cognitive development at 24 months assessed on the cognitive sub-scale of the Bayley Scales of Infant Development-Third Edition and maternal depression at 12 months measured by the EPDS. Analysis: The primary analysis will be a modified Intention-to-Treat analysis. The primary outcomes will be analysed using mixed-effects linear regression. Discussion: If this treatment is successful, policymakers could use this model of mental health-care delivered by lay-counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV.