RCT to evaluate an intervention for depressed HIV-positive women in the perinatal period, to enhance child development and reduce maternal depression

The majority of people living with HIV in the world live in sub-Saharan Africa (SSA), with women of child-bearing age carrying the greatest burden. Up to 35% of women attending antenatal clinics in some parts of South Africa are HIV-positive. Many receive their diagnosis during pregnancy when they are screened for HIV. Depression afflicts many HIV-positive women during pregnancy; over 40% score above the threshold for depression on screening questionnaires, and approximately 23% fulfil diagnostic criteria. Depression is associated with reduced adherence to ART, as well as low clinic attendance, suicidal thoughts, and low rates of exclusive breastfeeding. Moreover, perinatal depression has negative effects on parenting and early child development. Children born to depressed mothers are at increased risk of compromised cognitive development, behaviour and growth, especially when faced with socio-economic disadvantage and lack of support. There is also emerging evidence from a separate body of literature that HIV is associated with negative effects on caregiving and children's outcomes (the vast majority of these children are HIV-negative). Improving the wellbeing of mothers and infants requires effective treatment of perinatal depression, ensuring adherence to ART, as well as enhancing key parenting skills. In particular, depressed mothers often need help to sensitively respond to and care for their infants in order to mitigate the negative effects of depression on parenting. Our aim is to conduct a cluster RCT to test an integrated home-based intervention programme that jointly treats depression and enhances parenting. The intervention, delivered during pregnancy and the postnatal period, comprises a combination of behavioural activation (BA) therapy to treat the symptoms of depression and a parenting programme to improve maternal responsiveness to infants (CCD). BA is a structured therapeutic approach that focuses on increasing behaviours that are rewarding, improving mood and quality of life, and reducing behaviours that maintain or worsen depression such as passivity or avoidance and rumination. It has been shown to be as effective as CBT. This focus on behaviour rather than beliefs makes BA culturally acceptable. Another advantage of BA is that it does not require extensive training for delivery or complex skills from the therapist; thus lay counsellors can deliver this treatment. CCD, developed by WHO/UNICEF, has been shown to improve parenting and promote early child development in LMIC when integrated in existing health services. We have augmented CCD to focus particularly on parenting skills in early infant learning and attention, especially contingent responsiveness and the provision of early stimulation opportunities. The control treatment will be enhanced treatment as usual, comprising standard care with an additional in-person therapy session during pregnancy, two follow-up phone calls, and a parenting booklet in the postnatal period. The RCT will comprise 48 clusters (24 per arm) with 11 mothers (and infants) per cluster. This includes an additional 25% to take account of attrition, for a total of 528 mothers and infants. Women who meet criteria (i.e. have depression during pregnancy and are HIV-positive) will be recruited between 20 and 32 weeks of pregnancy and followed until the child is aged 2 years. The main aims of the trial are to test whether the intervention: 1. Improves child cognitive development at 2 years of age 2. Reduces maternal depression during pregnancy and the postnatal period 3. Increases maternal adherence to ART 4. Increases rates of exclusive breastfeeding 5. Improves maternal contingent responsiveness to infant cues and quality of cognitive and emotional stimulation 6. Improves child growth, behaviour, and language development, and reduces gastro-intestinal infections