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Clinical Trials/PACTR201710002683810
PACTR201710002683810
Completed
N/A

Integrating a Package of Home-based Early Childhood Intervetions into Existing Community Health Worker Protocols in South Africa: A Cluster Randomized Trial

Health Economics and Epidemiology Research Office0 sites2,236 target enrollmentOctober 11, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Biomarkers of systemic inflammation Mental and Behavioural Disorders
Sponsor
Health Economics and Epidemiology Research Office
Enrollment
2236
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 11, 2017
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Health Economics and Epidemiology Research Office

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

Primary Outcomes

Not specified

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