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Clinical Trials/NCT03195036
NCT03195036
Completed
Not Applicable

Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon

Duke University1 site in 1 country230 target enrollmentApril 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Childhood Development in HIV-Exposed Children
Sponsor
Duke University
Enrollment
230
Locations
1
Primary Endpoint
Attainment of age-appropriate developmental milestones
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

There is substantial evidence that early childhood development (ECD) programming can improve child health and development outcomes. An important component of ECD programming is supporting positive parenting and early stimulation practices. While many parents could benefit from such programming, mothers that are HIV-infected may particularly benefit given the higher risks of poorer child development among HIV-exposed children. Catholic Relief Services (CRS) in Cameroon is implementing the Key Interventions to Develop Systems and Services (KIDSS) ECD program for HIV-exposed children. This impact evaluation will ascertain to what extent the KIDSS home-based component of the ECD model affects attainment of age-appropriate developmental milestones (measured by the Ages and Stages Questionnaire 3 (ASQ-3)) in HIV-exposed children in Cameroon. The study design is a cluster-randomized controlled trial with a cohort of 200 mother/child dyads across 10 study clinics. HIV+ mothers will be recruited during pregnancy and their children will be followed up until 18 months of age. The intervention group will receive regular home-based ECD services focused on positive parenting and early stimulation. The control group will not have any exposure to ECD services, though they may receive home-based services focused on HIV care and treatment, hygiene, and nutrition. Randomization occurs at the clinic (cluster) level.

Registry
clinicaltrials.gov
Start Date
April 17, 2017
End Date
July 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joy Noel Baumgartner

Assistant Research Professor; Director, Evidence Lab

Duke University

Eligibility Criteria

Inclusion Criteria

  • HIV-positive
  • Pregnant and currently in 3rd trimester
  • Must reside in Nkoldongo district or Djoungolo district
  • Willing to be followed up for up to 21 months (pregnancy + postpartum periods)
  • Agrees to voluntary participation

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Attainment of age-appropriate developmental milestones

Time Frame: ASQ-3 score assessed 6 months after birth.

Child Development Outcomes, measured by ASQ-3 (6-month survey)

Secondary Outcomes

  • Attainment of age-appropriate developmental milestones(ASQ-SE score assessed at 18 months after birth.)

Study Sites (1)

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