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
South Africa, 2018 - 2023
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Reference ID
AHRI.Insika.Yomama.dataset
Producer(s)
Tamsen Rochat, Alan Stein, Samukelisiwe Dube, Kobus Herbst, Cecilia A. Hoegfeldt, Stephanie Redinger, Thandeka Khoza, Ruth Margret Bland, Linda Richter, Louise Linsell, Chris Desmond, Aisha K. Yousafzai, Michelle Craske, Ed Juszczak, Melanie Abas, Taygen Edwards, David Ekers
Metadata
Created on
Apr 10, 2026
Last modified
Apr 13, 2026
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Identification
Survey ID number
AHRI.Insika.Yomama.dataset
Title
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
Country
| Name | Country code |
|---|---|
| South Africa | ZA |
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 (ESoC). 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 counselling support and advice telephone calls.
In addition, measures have been taken to enhance the routine standard of care.
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 healthcare delivered by lay-counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV.
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 (ESoC). 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 counselling support and advice telephone calls.
In addition, measures have been taken to enhance the routine standard of care.
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 healthcare delivered by lay-counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV.
Kind of Data
Survey data, clinical data, psychological test data, program source codes, observation data, textual data
Unit of Analysis
Multiple records (assessments at different time points) for each study participant (n = 320)
Version
Version Description
v1.0.0
Scope
Topics
Keywords
Perinatal Depression, EPDS, Behavioural Activation, HIV, Parenting, Child Development, Bayley Developmental Assessment, Lay-counsellors, CBCL, PSI-SF, Pregnancy
Coverage
Geographic Coverage
The trial is being conducted at the Africa Health Research Institute (AHRI) Somkhele Research Campus in rural Northern KwaZulu-Natal, South Africa, within AHRI's Population Intervention Platform demographic surveillance area. The study area covers 845km2 and the community is predominantly rural but contains an urban township and informal peri-urban settlements (54,55). The resident population is approximately 100,000 people (~20,000 households) of which the majority are isiZulu-speaking. The area includes one district-level hospital and 17 primary healthcare facilities. The unit of randomisation is the cluster using the geospatial location of the participant's home. There are approximately 300 neighbourhoods in the region included in this trial; these are defined by geographical area as well as population density so that they are equivalent in terms of sample size. The distinct neighbourhoods have been merged into 48-60 clusters to ensure comparable clusters in terms of key indicators, including population size
Producers and sponsors
Primary investigators
| Name | Affiliation |
|---|---|
| Tamsen Rochat | SAMRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, South Africa, SAMRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, South Africa DSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa |
| Alan Stein | Africa Health Research Institute, KwaZulu-Natal, South Africa, Department of Psychiatry, University of Oxford, UK, MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg |
| Samukelisiwe Dube | Africa Health Research Institute, KwaZulu-Natal, South Africa |
| Kobus Herbst | Africa Health Research Institute, KwaZulu-Natal, South Africa, DSI-MRC South African Population Research Infrastructure Network (SAPRIN), Durban, South Africa |
| Cecilia A. Hoegfeldt | Department of Psychiatry, University of Oxford, UK |
| Stephanie Redinger | SAMRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, South Africa, DSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa |
| Thandeka Khoza | Africa Health Research Institute, KwaZulu-Natal, South Africa |
| Ruth Margret Bland | Institute of Health and Wellbeing and Royal Hospital for Children, University of Glasgow, UK |
| Linda Richter | DSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa |
| Louise Linsell | National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford |
| Chris Desmond | Priceless, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa |
| Aisha K. Yousafzai | Harvard T.H. Chan School of Public Health, Boston, USA |
| Michelle Craske | UCLA, USA |
| Ed Juszczak | National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford |
| Melanie Abas | Institute of Psychiatry, Psychology and Neuroscience, King’s College London |
| Taygen Edwards | Africa Health Research Institute, KwaZulu-Natal, South Africa |
| David Ekers | SAMRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, South Africa, Africa Health Research Institute, KwaZulu-Natal, South Africa |
Producers
| Name |
|---|
| Africa Health Research Institute |
Funding Agency/Sponsor
| Name | Abbreviation | Role |
|---|---|---|
| Joint Global Health Trials (MRC(UK)/DFID/Wellcome | JGHT | Funder |
| UK Research and Innovation | UKRI | Funder |
| Oxford Health Biomedical Research Centre (BRC) | BRC | Funder |
Sampling
Sampling Procedure
The first primary outcome is the cognitive subscale on the BSID-III at 24 months of age. To achieve a power of over 90% (two-sided t-test with a significance level of 0.05), and assuming an estimated difference of 6 points (SD 15), a total sample size of 396 women (198 per arm) is required. This calculation takes into account geospatial clustering (28 clusters per arm with an intra-cluster correlation coefficient (ICC) of 0.05) and 'counsellor effect' in the intervention arm (4 lay counsellors with an ICC of 0.05). To take account of attrition of up to 25% a total sample size of 528 women is being recruited (264 per arm, 48-60 geospatial clusters, 9-11 women per cluster). Using the EPDS assessment with a standard deviation of 5, with the same assumptions of clustering as above, a difference of 2 points between trial arms (not adjusting for baseline or repeated measurements) could be detected with 90% power and a 5% two-sided significance level. Analysis using repeated measures, taking into account within-participant correlation over time, would allow smaller differences to be detected with the same power
Data collection
Dates of Data Collection
| Start | End |
|---|---|
| 2018-04-01 | 2023-09-30 |
Data processing
Data Editing
The data collected and captured on REDCap was uploaded to a MySQL database server within AHRI's secure server cluster.
Access policy
Access conditions
Access to the data requires accurate completion of the online data access application form accessible on the AHRI Data repository(<https://data.ahri.org/>). Data users are required to abide by the data use conditions stipulated on the application for access to the data. Failure to do so may result in their data access privileges being revoked by the Data Custodian. In order to recognise the effort and intellectual contributions of AHRI investigators in producing and curating the data, users of AHRI data must acknowledge the source of the data and abide by the terms and conditions under which the data is accessed and must cite the dataset in publication using the citation provided as part of this documentation. All analytical datasets published on the AHRI Data Repository are assigned digital object identifier (DOIs) and the DOIs can be found on the Data Repository under Study Description tab - Access policy. AHRI data users are required to always cite the dataset using the relevant DOI.
Citation requirements
Rochat, T., Stein, A., Dube, S., Herbst, K., Hoegfeldt, C. A., Redinger, S., Khoza, T., Bland, R. M., Richter, L., Linsell, L., Desmond, C., Yousafzai, A. K., Craske, M., Juszczak, E., Abas, M., Edwards, T., & Ekers, D. (2026). 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 [Data set]. Africa Health Research Institute.
DOI:https://doi.org/10.23664/AHRI.INSIKA.YOMAMA.DATASET
DOI:https://doi.org/10.23664/AHRI.INSIKA.YOMAMA.DATASET
Metadata production
DDI Document ID
DDI.AHRI.Insika.Yomama.dataset
Producers
| Name | Abbreviation |
|---|---|
| Africa Health Research Institute | AHRI |