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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2019-07-30

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.

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Detailed Description

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Conditions

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Early Childhood Development in HIV-Exposed Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

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.

Group Type EXPERIMENTAL

Home-based ECD services

Intervention Type BEHAVIORAL

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.

Interventions

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Home-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.

Intervention Type BEHAVIORAL

Other Intervention Names

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KIDSS Project Home-Based Visits

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No