NCT03195036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

June 16, 2017

Last Update Submit

October 10, 2019

Conditions

Early Childhood Development in HIV-Exposed Children

Keywords

HIV-exposedEarly Childhood DevelopmentCameroon

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Attainment of age-appropriate developmental milestones

    ASQ-SE score assessed at 18 months after birth.

Study Arms (2)

Control

NO INTERVENTION

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

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

Interventions

Home-based ECD servicesBEHAVIORAL

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.

Also known as: KIDSS Project Home-Based Visits
Intervention Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic Relief Services

Yaoundé, Cameroon

Location

Study Officials

  • Joy N Baumgartner, PhD, MSSW

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor; Director, Evidence Lab

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 22, 2017

Study Start

April 17, 2017

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)