Perinatal depression is very common amongst HIV-positive women, with up to 40% of HIV-positive mothers in parts of southern Africa being affected. Insika Yomama is a treatment trial to evaluate an intervention for depressed HIV-positive women in the perinatal period to enhance child development and reduce maternal depression.
Perinatal depression is associated with poor adherence to anti-retroviral therapy (ART), low clinic attendance, suicidal ideation and low rates of breastfeeding. Critically, perinatal depression is also associated with negative effects on parenting, which in turn adversely impacts children's cognitive and behavioural development and growth. Effective treatments for HIV-positive perinatal populations are urgently needed, and given that the prevalence of both HIV and perinatal depression is high in low-resource settings, treatments which take an integrated approach, targeting both depression and parenting, have substantial potential.
The aim of this cluster randomised controlled trial is to investigate whether a psychological intervention, integrating Behavioural Activation (BA) for depression and a parenting programme, leads to better cognitive development in children at 24 months and, also reduces perinatal depression in HIV-positive women at 12 months, compared to enhanced standard of care (ESoC).
Behavioural Activation (BA) is based on the evidence that increased activity (i.e., activation), and the resulting positive consequences, leads to reduction of depressive symptoms. A parenting intervention aims to help the mother increase the stimulation she provides to her baby. In particular, the mother is helped to focus on her baby’s cues and signals and she is given support in providing a range of activities to enhance her child’s development especially cognitive development. The parenting programme was adapted from the ‘Care for Child Development’ package developed by UNICEF and WHO. We have combined these two, BA and the parenting programme, into a home-based integrated intervention package that can be delivered feasibly by lay counsellors.
Participants are being recruited through referrals from the antenatal care services at 15 Department of Health Primary Health Care clinics in rural KwaZulu-Natal, South Africa. Inclusion criteria include: pregnant women, aged 16 and above, who are living with an HIV diagnosis, are conversant in either English or IsiZulu and who plan to live with their child for at least the first 9 months following childbirth. Those who meet these inclusion criteria, are screened for depression using the Edinburgh Postnatal Depression Scale (EPDS). Women who meet the depression screening criteria (≥9) and are willing and able to give informed consent for participation in the trial are enrolled.
The participants are assigned to a cluster based on homestead location, used to determine whether a participant is allocated to either the intervention or control arm. If randomised to the intervention arm, participants receive ten home-based sessions (delivered by lay counsellors trained on Behavioural Activation and the adapted Care for Child Development Package), four sessions during the 3rd trimester of pregnancy and six sessions postnatally. One booster session is given when the child is 16 months old. Participants allocated to the control arm receive ESoC (Enhanced Standard of Care) which includes two antenatal and two postnatal supportive telephone calls in addition to the current standard of care.
Project period: 1 April 2017 to 31 March 2022
Funding: This study is funded by the Joint Global Health Trials Panel; DfID, MRC UK, & the Wellcome Trust, and administered by the MRC UK.