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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201802003137364 |
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Date of registration:
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22/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Determining the Effects of layered multi-component interventions on the Early Childhood Stimulation (ECS) among PMTCT mother baby pairs
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Scientific title:
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Determining the Effects of layered multi-component interventions on the Early Childhood Stimulation (ECS) among PMTCT mother baby pairs |
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Date of first enrolment:
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01/01/2018 |
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Target sample size:
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470 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3137 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Non-randomised
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Phase:
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Not Applicable
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Countries of recruitment
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Swaziland
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Contacts
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Name:
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Qhing Qhing
Dlamini |
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Address:
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P.O. Box 3302
+268
Mbabane
Swaziland |
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Telephone:
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+268 7604 9175 |
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Email:
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qhing2@gmail.com |
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Affiliation:
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Medical Doctor/ Public Health Specialist |
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Name:
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Collen
Masibhera |
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Address:
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P. O. Box 6006, M200
+268
Manzini
Swaziland |
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Telephone:
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+268 76333628 |
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Email:
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collen_masibhera@bantwana.org |
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Affiliation:
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Technical Director/ Bantwana Initiatives |
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Key inclusion & exclusion criteria
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Inclusion criteria: 0-1year old infants at enrolment
HIV+, HIV affected and exposed mothers,
Kinship custodian (e.g. cared by grandmother) of 0-2 year old infants,
Provide written consent to participate in the study,
Verified resident in Lubuli Inkhundla. A letter may be obtained from Bucopho or Headman as means of verification.
Consent from elders/adults for mothers below the age of 18 years
Exclusion criteria: Not biological mother or primary caregiver of the 0-1 year infant
Specific plan to move outside the targeted Lubuli Inkhundla.
Does not provide written consent to participate in the study.
No consent from elders/adults for mothers below the age of 18 years.
Age minimum:
0 Year(s)
Age maximum:
60 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
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HIV/AIDS
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Intervention(s)
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Block A
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Block B
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Primary Outcome(s)
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Improved nutrition (weight for height ratios) of infants
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Improved global measure of Early Childhood Stimulation (ECS) cognitive, gross motor, fine motor, language and expression
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Increased retention to health/nutrition services
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Improved parent economic resilience
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Secondary Outcome(s)
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Improved long term child development outcomes
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Source(s) of Monetary Support
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Grand Challenges Canada
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World Education Inc
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Ethics review
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Status: Approved
Approval date: 14/11/2017
Contact:
Swaziland Health Research Review Board
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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