Perinatal depression in women with HIV infection Mental and Behavioural Disorders
Conditions
Interventions
Participants are randomised by cluster, based on homestead location at enrolment, with outcome assessors blind to treatment allocation:
1. 10-session home-based counselling intervention delivered by l
Sponsors
The University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/12/2022: 1. Pregnant women, 23-33 weeks gestation at the time of enrolment 2. Participant is willing and able to give informed consent for participation in the trial 3. Aged 16 years and above 4. Diagnosed HIV-positive 5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS 6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period) 7. Mother conversant in isiZulu or English Current inclusion criteria as of 25/01/2019 to 14/12/2022: 1. Pregnant women, <33 weeks gestation at time of enrolment 2. Participant is willing and able to give informed consent for participation in the trial 3. Aged 16 years and above 4. Diagnosed HIV-positive 5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS 6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period) 7. Mother conversant in isiZulu or English Previous inclusion criteria: 1. Pregnant women, <33 weeks gestation at time of enrolment 2. Participant is willing and able to give informed consent for participation in the trial 3. Aged 16 years and above 4. Diagnosed HIV-positive 5. Mother meets criteria for antenatal depression as defined by 13 and greater on the EPDS 6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period) 7. Mother conversant in isiZulu or English
Exclusion criteria
Exclusion criteria: 1. Any significant disease, disorder or disability which, in the opinion of the Principal Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes hospitalisation for at least three days for severe psychiatric illness (specifically bipolar disorder, schizophrenia and any other psychoses), or a life-threatening or other serious physical illness (excluding HIV and tuberculosis) 2. Current suicidal ideation/thoughts with specific plans and means identified 3. Substance or alcohol use disorder 4. Currently receiving a psychological treatment for mental health problems 5. Participant planning to move away from the study area before 9 months postnatal 6. Mother not planning to cohabit with the infant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary outcome measures: 1. Child cognitive development, measured using the Bayley Scales of Infant and Toddler Development III (cognitive subscale) at child age 24 months 2. Maternal depression, measured using the Edinburgh Postnatal Depression Scale (EPDS) at 12 months postnatal | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/12/2022: 1. Maternal depression, measured using the Edinburgh Postnatal Depression Scale (EPDS) at the end of pregnancy and child age 24 months 2. Generalized Anxiety Disorder 7-item (GAD-7) scale at the end of pregnancy and child age 24 months 3. Adherence to ART, measured as viral load (VL) and viral suppression post-initiation of treatment over the entire trial period 4. Exclusive breastfeeding to 6 months by self-report in an interview at 6 months postnatal 5. Compliance with immunisation schedule over the 24-month postnatal period, by maternal report at interview and clinic record at 12 weeks, 12 and 24 months postnatal 6. Any instances of infant diarrhoea in the preceding two weeks, assessed by the maternal report in an interview at 12 weeks, 6 months, 12 months and the 24 months 7. Cognitive and emotional stimulation at home, assessed by Multiple Indicator Cluster Survey 6 (MICS6) at 12 and 24 months 8. Infant behaviour, assessed using the Parent-Child Dysfunctional Interaction subscale and Difficult Child subscale of the Parenting Stress Index Short Form (PSI-SF) at child age of 12 months, and the Externalising Subscale of the Child Behaviour Checklist (CBCL) at 24 months 9. Infant language development, measured using the BSID-III language sub-scale at child age 24 months 10. Child growth - height and weight for child age measured at 24 months Previous secondary outcome measures: 1. Maternal depression, measured using the Edinburgh Postnatal Depression Scale (EPDS) at the end of pregnancy and child age 24 months 2. Generalized Anxiety Disorder 7-item (GAD-7) scale at the end of pregnancy and child age 24 months 3. Adherence to ART, measured as viral load (VL) and viral suppression post-initiation of treatment over the entire trial period 4. Exclusive breastfeeding to 6 months by self-report in interview at 6 months postnatal 5. Compliance to immunisation schedule over the 24-month postnatal period, by maternal rep | — |
Countries
South Africa
Outcome results
None listed