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.: PACTR201801002967587 Date of Approval: 11/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Neurodevelopmental Assessment of Early-treated HIV-infected Children
Official scientific title Neurodevelopmental Assessment of Early-treated HIV-infected Children
Brief summary describing the background and objectives of the trial The early neurodevelopment of a significant number of HIV-infected and HIV-exposed uninfected children is at risk because of infection with, or exposure to, the HI virus. Effective interventions stimulating early childhood development can have far-reaching positive outcomes, but little is known about the long-term impact of an intervention started at birth in conjunction with very early ART initiation. The aim of this study is to compare neurodevelopmental outcomes of early-treated HIV-infected children receiving an age appropriate stimulation program with HIV-infected and HIV-exposed uninfected children not having received an intervention.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Early Childhood Development,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/09/2017
Actual trial start date 07/09/2017
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
DOH-27-1017-5841 South African Clinical Trials Network
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 Non-randomised Unblinded Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group None NA NA No intervention 175 Historical
Experimental Group Early Childhood Developmental Stimulation Box NA 12 months Children will receive age appropriate developmentally stimulating items every three months from birth through the first year of life. An information sheet on early childhood development will be provided to the caregivers at three monthly intervals 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
POC or laboratory-based infant diagnostic test positive on a sample collected within 48 hours of birth, the mother willing and able to provide informed consent. Expressed intention to leave the Johannesburg area permanently, co-morbidities, birth defects or other conditions which in the opinion of the clinical team have a greater than 50% risk of mortality in the first days of life, active (uncontrolled) maternal psychiatric illness. 1 Day(s) 2 Day(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 04/08/2017 University of the Witwatersrand, Human Research Ethics Committee (Medical)
Ethics Committee Address
Street address City Postal code Country
Phillip Tobias Building, 3rd floor, Office 302, Corner York Road and 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the neurodevelopment of a cohort of early-treated HIV positive children receiving an early childhood stimulation intervention with a cohort of early-treated HIV positive children and HIV-exposed uninfected children not having received the intervention. 12 months of age
Secondary Outcome To describe the neurodevelopment of a cohort of perinatally-infected HIV positive children initiated on antiretroviral treatment in infancy. At either 12, or 24, or 36 months of age
Secondary Outcome To compare the neurodevelopment of a cohort of early-treated HIV positive children with a control group of HIV-exposed uninfected children At either 12, or 24, or 36 months of age
Secondary Outcome To investigate associations between neurodevelopmental outcomes and environmental factors using the Household Survey and Parenting Stress Index-SF, in early treated perinatally-infected HIV positive children and HIV-exposed uninfected children. at end of the three year study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Empilweni Services and Research Unit (ESRU) Nkanyezi Building/B-Block, Rahima Moosa Mother and Child Hospital, Cnr Fuel and Oudtshoorn Streets Johannesburg 2093 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Self-funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Empilweni Services and Research Unit (ESRU) Nkanyezi Building/B-Block, Rahima Moosa Mother and Child Hospital, Cnr Fuel and Oudtshoorn Streets Johannesburg 2093 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Louise Kuhn Sergievsky Center, 622 W 168th Street, 19th Floor Room 113. New York 10032 United States of America
Joanne Potterton Department of Physiotherapy Faculty of Health Sciences 7 York Road Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Renate Strehlau renate.strehlau@wits.ac.za +27114709214 Rahima Moosa Hopital, Coronationville
City Postal code Country Position/Affiliation
Johannesburg 2093 South Africa Deputy Director ESRU
Role Name Email Phone Street address
Public Enquiries Renate Strehlau renate.strehlau@wits.ac.za +27114709214 Rahima Moosa Hopital, Coronationville
City Postal code Country Position/Affiliation
Johannesburg 2093 South Africa Deputy Director ESRU
Role Name Email Phone Street address
Scientific Enquiries Renate Strehlau renate.strehlau@wits.ac.za +27114709214 Rahima Moosa Hopital, Coronationville
City Postal code Country Position/Affiliation
Johannesburg 2093 South Africa Deputy Director ESRU
REPORTING
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