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

Study Overview
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Brief Summary
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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.

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

Conditions
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Early Childhood Development in HIV-Exposed Children

Intervention / Treatment
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* Behavioral: Home-based ECD services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group of women/children dyads who consent and are patients at the control clinics will not have any exposure to ECD programming. | |
| Experimental: Intervention Arm<br>The intervention group of women/children dyads who consent and are patients at the intervention clinics will receive regular home-based ECD services focused on positive parenting and early stimulation. | Behavioral: Home-based ECD services<br>* 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.<br>* Other names: KIDSS Project Home-Based Visits;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment of age-appropriate developmental milestones | Child Development Outcomes, measured by ASQ-3 (18-month survey) | ASQ-3 score assessed 18 months after birth. | 
| Attainment of age-appropriate developmental milestones | Child Development Outcomes, measured by ASQ-3 (12-month survey) | ASQ-3 score assessed 12 months after birth. | 
| Attainment of age-appropriate developmental milestones | Child Development Outcomes, measured by ASQ-3 (6-month survey) | ASQ-3 score assessed 6 months after birth. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment of age-appropriate developmental milestones | Child Development Outcomes, measured by ASQ-Social Emotional (SE) | ASQ-SE score assessed at 18 months after birth. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-exposed, Early Childhood Development, Cameroon