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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03195036
Enrollment
230
Registered
2017-06-22
Start date
2017-04-17
Completion date
2019-07-30
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Development in HIV-Exposed Children

Keywords

HIV-exposed, Early Childhood Development, Cameroon

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.

Interventions

BEHAVIORALHome-based ECD services

Health facilities will be randomized to intervention and control groups. The clients at clinics assigned to the intervention group will receive Home-based Early Childhood Development (ECD+) program. The clients at clinics assigned to the control group will not receive the Early Childhood Development (ECD) program.

Sponsors

Catholic Relief Services
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study utilizes a cluster-randomized trial (CRT) design in order to evaluate the impact of the KIDSS ECD program delivered by Catholic Relief Services, specifically the home visiting component, on child development outcomes and utilization of HIV testing services. The main reason for including randomization is to reduce the risk of selection bias. The unit of inference for this CRT is at the individual level but the unit of randomization is the health facility (cluster) level due to issues of program feasibility.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Attainment of age-appropriate developmental milestonesASQ-3 score assessed 18 months after birth.Child Development Outcomes, measured by ASQ-3 (18-month survey)

Secondary

MeasureTime frameDescription
Attainment of age-appropriate developmental milestonesASQ-SE score assessed at 18 months after birth.Child Development Outcomes, measured by ASQ-Social Emotional (SE)

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026