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.: PACTR201701001387209 Date of Approval: 11/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Child Health Intervention for Development Outcomes (CHIDO)
Official scientific title A trial to determine the effects of a comprehensive community based, multi-component intervention on early childhood development, household economic resilience and adherence and retention in paediatric HIV treatment and care programmes
Brief summary describing the background and objectives of the trial Studies on children infected and affected by HIV have clearly shown poorer child development outcomes than uninfected and unaffected children. The overall goal of the trial is: to determine whether it is possible to improve ECD, parenting, economic resilience and HIV retention and care outcomes among HIV exposed and infected infants aged 0-2 years as well as retention in care among their mothers using a comprehensive, community-based intervention which combines early childhood stimulation through parenting skills training; economic strengthening; case management. The intervention will be tested in a cluster randomised trial conducted in 30 community clusters, which will be randomised to either standard of care or the community based intervention. 480 HIV infected women and their 0-2 year old children will be recruited to the trial. In the 15 intervention communities women and their children will attend a group intervention every two weeks to receive training in i) early childhood stimulation ii) running an internal savings and lending scheme. In addition women will receive home visits to support their adherence and retention in care. Mother -child pairs in the comparison communities will receive usual clinic based HIV care. Outcomes will be measured at 12 months (and possibly at 24 months - funding permitting). Primary outcomes will be compared between trial arms and are i) global childhood development score (measured using the Mullen Early Learning Scale) in the child; ii) retention in HIV care in the HIV exposed child. In addition we will explore a range of secondary outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CHIDO
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 13/01/2016
Actual trial start date 25/01/2016
Anticipated date of last follow up 30/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 480
Actual target sample size (number of participants) 480
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Minimisation Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CHIDO intervention 2 hour community group every 2 weeks 12 months Community based, group delivered early childhood stimulation training couple with an internal savings and lending scheme and monthly home visits to support retention in care 240
Control Group Standard of care As per national guidelines 12 months Standard of care for HIV exposed infants 240
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children who are HIV exposed or confirmed HIV infected aged 0-2 years Living in the catchment areas of trial health care facilities Singleton births Planning to live full time in the community for the following 24 months Able to attend bi-weekly meetings in the community Prepared to provide their residential address and other locator information Children with chronic illness or disability Planning to travel away from the area in the next 24 months. 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 25/06/2015 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Cnr Joshiah Tongogara and Mazowe St Harare Zimbabwe
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 13/07/2015 University College London
Ethics Committee Address
Street address City Postal code Country
Gower Street London WC1E 6AU United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome % of HIV exposed or infected children with full retention in care (>80%) at 12 months will be determined from the child health card cross referenced with the clinic registers and the case manager records. Baseline and 12 months
Secondary Outcome The Early Childhood development sub-scales will be measured using the Mullen Scales of Early Learning Baseline and 12 months
Secondary Outcome Child height and weight will be measured using standard procedures Baseline and 12 months
Secondary Outcome Parenting stress will be measured using the 36 item Parenting Stress Index-Short Form (PSI-SF). Baseline and 12 months
Secondary Outcome % of HIV infected mothers retained in care will be assessed using clinic records and patient had held report card. Baseline and 12 months
Secondary Outcome % of HIV infected mothers with a suppressed HIV viral load at 12 months will be assessed on dried blood spot samples using NucliSENS EasyQ HIV-1 assay (BioMe´rieux, Inc., Madrid, Spain) Baseline and 12 months
Secondary Outcome % of HIV exposed or infected children retained in care at 12 months will be determined from the child health card cross referenced with the clinic registers and the case manager records Baseline and 12 months
Secondary Outcome % of HIV exposed or infected children reporting > 95% adherence to cotrimoxazole +/- ART as appropriate in the previous 24 hours and previous 7 days. Baseline and 12 months
Secondary Outcome Maternal mental health measured using SSQ8 and EPND scale Baseline and 12 months
Secondary Outcome Household Food Security measured using modified HFIAS Baseline and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Henry John Rheimer clinic Goromonzi District Zimbabwe
Kawoyo clinic Goromonzi District Zimbabwe
Chinamhora clinic Goromonzi District Zimbabwe
Chinyika clinic Goromonzi District Zimbabwe
Kubatsirana clinic Goromonzi District Zimbabwe
Masikandoro clinic Goromonzi District Zimbabwe
Melfort clinic Goromonzi District Zimbabwe
Mwanza Rural health centre clinic Goromonzi District Zimbabwe
Nyawure clinic Goromonzi District Zimbabwe
Pote clinic Goromonzi District Zimbabwe
Rusike clinic Goromonzi District Zimbabwe
Ruwa clinic Goromonzi District Zimbabwe
Nyamapanda Clinic Mudzi District Zimbabwe
Kotwa Clinic Mudzi District Zimbabwe
Suswe Mudzi District Zimbabwe
Masarakufa Clinic Mudzi District Zimbabwe
Dendera Clinic Mudzi District Zimbabwe
Kondo Clinic Mudzi District Zimbabwe
Goromonzi Clinic Mudzi District Zimbabwe
Shinga Clinic Mudzi District Zimbabwe
Mavhurazi clinic Mudzi District Zimbabwe
Makaha Clinic Mudzi District Zimbabwe
Acturus Mine Clinic Goromonzi District Zimbabwe
Bosha Rural Health centre Goromonzi District Zimbabwe
Bromley Clinic Goromonzi District Zimbabwe
Chikwaka Rural Hospital Goromonzi District Zimbabwe
Cranborne Clinic Goromonzi District Zimbabwe
Domboshava Training Centre clinic Goromonzi District Zimbabwe
Gejo raRuby clinic Goromonzi District Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
USAID Washington DC United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Education International Commercial Sector/Industry
Primary Sponsor World Education International Commercial Sector/Industry
Primary Sponsor World Education International Commercial Sector/Industry
Primary Sponsor World Education International 44 Farnsworth Street Boston, MA 02210 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof Mark Tomlinson University of Stellenbosch Stellenbosch South Africa
Prof Lorraine Sherr University College London London WC1E 1HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lorraine Sherr l.sherr@ucl.ac.uk +44 20 7794 0500 Univ College London, Roayl Free Campus, Rowland Hill Streer
City Postal code Country Position/Affiliation
London NW3 2PF United Kingdom Professor of Clinical and Health Psychology
Role Name Email Phone Street address
Public Enquiries Rudo Chingono rudo@ceshhar.co.zw +2634308042
City Postal code Country Position/Affiliation
Harare Zimbabwe Trial coordinator
Role Name Email Phone Street address
Scientific Enquiries Frances Cowan f.cowan@ucl.ac.uk +2634308042 9 Monmouth Road
City Postal code Country Position/Affiliation
Harare Zimbabwe co PI
REPORTING
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