Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002683810 Date of Approval: 11/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integrating a Package of Home-based Early Childhood Intervetions into Existing Community Health Worker Protocols in South Africa: A Cluster Randomized
Official scientific title Integrating a Package of Home-based Early Childhood Intervetions into Existing Community Health Worker Protocols in South Africa: A Cluster Randomized Trial
Brief summary describing the background and objectives of the trial In this project, we will conduct a cluster-randomized trial to evaluate the impact of an innovative package of early childhood interventions delivered by community health workers (CHWs) during routine home-based maternal and child health visits. We will spend the first year of the project period developing and pre-testing a package of interventions. We anticipate including a set of interventions found to be effective in settings similar to South Africa: reinforced support for a set of iCCM protocols to address child illness; parental training in IYCF practices to improve early-life nutrition; support for cognitive stimulation methods to improve cognitive and socioemotional development; and CBT to address maternal depression. To maximize the feasibility of package uptake by CHWs, we plan to adapt existing curricula used for similar interventions in other settings. The primary outcomes for the proposed study are: i) an assessment of the feasibility of the intervention package; and ii) evidence of the impact of the intervention package on child health and development indicators. In addition, we will conduct repeated neurocognitive assessments (e.g. electroencephalogram to monitor brain activity and eye-tracking) among a randomly selected subsample of caregiver/child dyads aims to test the developmental impact of the child development intervention package delivered at the home by CHWs. We will also conduct autonomic assessments of each child’s heartbeat and breathing to explore how physical health relates to neurocognitive development. During the final lab visit, we will collect blood samples from children and tested for biomarkers of systemic inflammation to explore the relationship between inflammation and neurocognitive development. Finally, an additional sample of 50 additional caregiver/child pairs of high socioeconomic status (SES) will be recruited from Greater Tzaneen and assessed with EEG and ET technologies to explore the relationship between household wealth and child neurodevelopment
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ACT SA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Biomarkers of systemic inflammation Mental and Behavioural Disorders
Purpose of the trial Education /Training
Anticipated trial start date 23/10/2017
Actual trial start date 23/10/2017
Anticipated date of last follow up 01/04/2019
Actual Last follow-up date 31/05/2020
Anticipated target sample size (number of participants) 2236
Actual target sample size (number of participants) 1100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
South African National Clinical Trial Register NHREC number 4407
Limpopo Provincial Government - Department of Health LP_2016_RP36_866 Approval reference: 4/2/2
Wits HREC Medical Protocol number M160251
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised A short questionnaire will be used to collect information from all CHWs in Greater Tzaneen and Greater Giyani. This information will be used for the randomization procedure. A covariate constrained randomization procedure will be used to balance treatment groups on key descriptive variables (e.g., population demographics, indicators of disease burden) and increase statistical power. Allocation determined by the holder of the sequence who is situated off site. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Innovative package of home based interventions designed to improve early childhood development. Monthly 18 - 24 months Innovative package of home-based interventions designed to improve early childhood development. 550
Control Group Control Monthly 18 - 24 Months Existing CHW curriculum - standard care protocols 550 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The primary eligibility criterion for CHWs is that they must be currently active at the time of the study and they must be conducting home-based child health visits as part of their routine activities. Nearly all CHWs in the District meet these criteria. Other eligibility criterion for CHWs include: 1. Must be a CHW for more than three months 2. Must be at least 18 years of age or older 3. Must have completed the Phase I training 4. Must not be using mHealth as part of routine activities 5. Must not be enrolled or actively participating in another research project 6. Must be willing to provide informed consent Inclusion criteria for child/caregiver pairs i. Households within study CHW catchment areas with a child recruited soon after birth, but within 90 days from when the CHW completes training and starts enrolling households in that cluster. ii. Mother or primary care giver must be 18 years or older; Exclusion criteria for child/caregiver pairs i. Caregivers who are unwilling to provide informed consent; ii. Families that plan to move from their CHW catchment zone during the twelve month period of the study 0 Year(s) 2 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/06/2016 University of the Witwatersrand Human Ethics Research Committee (HREC)-Medical
Ethics Committee Address
Street address City Postal code Country
Philip Tobias Building, 3rd Floor, Office 304. Corner York and 29 Princess of Wales Terrace, Parktown, 2193 Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean HAZ (and stunting, defined as HAZ < -2): Heights of study children will be measured at baseline and endline; HAZ will be computed according to WHO child growth standards. 18 - 24 months
Primary Outcome BSID-III composite scores: Study children will be assessed at endline using the BSID-III, which includes five domains of neurocognitive development: cognition; language; motor; adaptive behavior; and social-emotional. 18 - 24 months
Secondary Outcome An assessment of the feasibility of the intervention package 18 - 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health Economics and Epidemiology Research Office 21 Peace street Tzaneen 0850 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Francie van Zijl Drive, Parow Valley Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Health Economics and Epidemiology Research Office Unit 2, 39 Empire road, Parktown Johannesburg 2193 South Africa Commercial Sector/Industry
Primary Sponsor Wits Health Consortium 8 Blackwood Avenue, Parktown Johannesburg 2193 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Peter Rockers Department of Global Health at the Boston University School of Public Health Boston United States of America
David Hamer Global Health and Medicine at the Boston University School of Public Health and School of Medicine, Crosstown Center Boston, Massachusetts CT 308 United States of America
Jukka Leppanen Tampere University Tampere Finland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Denise Evans devans@heroza.org +27827138857 Unit 2, 39 Empire road, Parktown
City Postal code Country Position/Affiliation
Gauteng 2193 South Africa Senior Researcher
Role Name Email Phone Street address
Public Enquiries Lotshiwe Cheuka lcheuka@heroza.org 27100017932 Unit 2 39 Empire road Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Program Head
Role Name Email Phone Street address
Scientific Enquiries Denise Evans devans@heroza.org +27827138857 Unit 2, 39 Empire road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information