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

Duke University

Status: Completed

Conditions: Early Childhood Development in HIV-Exposed Children

Treatments: Behavioral: Home-based ECD services

Study type: Interventional

Funder types: Other

Identifiers

NCT03195036

D0989

2017/02/867/CE/CNERSH/SP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Control

No Intervention group

Description:

The control group of women/children dyads who consent and are patients at the control clinics will not have any exposure to ECD programming.

Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Home-based ECD services