Early Childhood Development in HIV-Exposed Children Clinical Trial
Official title:
Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
| Verified date | October 2019 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 230 |
| Est. completion date | July 30, 2019 |
| Est. primary completion date | July 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Cameroon | Catholic Relief Services | Yaoundé |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | Catholic Relief Services |
Cameroon,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Attainment of age-appropriate developmental milestones | Child Development Outcomes, measured by ASQ-3 (18-month survey) | ASQ-3 score assessed 18 months after birth. | |
| Primary | Attainment of age-appropriate developmental milestones | Child Development Outcomes, measured by ASQ-3 (12-month survey) | ASQ-3 score assessed 12 months after birth. | |
| Primary | 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 | Attainment of age-appropriate developmental milestones | Child Development Outcomes, measured by ASQ-Social Emotional (SE) | ASQ-SE score assessed at 18 months after birth. |