Clinical trial NCT03195036: Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
Official title: Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Childhood Development in HIV-Exposed Children
Keywords: HIV-exposed
Early Childhood Development
Cameroon
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Catholic Relief Services
First posted: 2017-06-22
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Attainment of age-appropriate developmental milestones
timeFrame: ASQ-3 score assessed 18 months after birth.
measure: Attainment of age-appropriate developmental milestones
timeFrame: ASQ-3 score assessed 12 months after birth.
measure: Attainment of age-appropriate developmental milestones
timeFrame: ASQ-3 score assessed 6 months after birth.
Secondary outcomes:
measure: Attainment of age-appropriate developmental milestones
timeFrame: ASQ-SE score assessed at 18 months after birth.
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Catholic Relief Services
Study officials:
affiliation: Duke University
name: Joy N Baumgartner, PhD, MSSW
role: PRINCIPAL_INVESTIGATOR
References: