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Trial record 1 of 1 for:    NCT03195036
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Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon

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ClinicalTrials.gov Identifier: NCT03195036
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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. The program will include home-, facility-, and community-based components. 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 as well as exposure to facility- and community-based ECD programming. The control group will only have exposure to the facility- and community-based ECD programming. Randomization occurs at the clinic (cluster) level.

Condition or disease Intervention/treatment
Early Childhood Development in HIV-Exposed Children Behavioral: Home-based ECD services

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : April 17, 2019
Estimated Study Completion Date : July 17, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
The control group of women/children dyads who consent and are patients at the control clinics will only have exposure to the facility- and community-based ECD programming.
Experimental: 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 as well as exposure to facility- and community-based ECD programming.
Behavioral: 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 in addition to facility- and community-based messages on ECD. The clients at clinics assigned to the control group will not receive the Early Childhood Development (ECD) program; however, they will only exposed to facility- and community-based ECD programming.
Other Name: KIDSS Project Home-Based Visits


Outcome Measures

Primary Outcome Measures :
  1. Attainment of age-appropriate developmental milestones [ Time Frame: ASQ-3 score assessed 18 months after birth. ]
    Child Development Outcomes, measured by ASQ-3 (18-month survey)

  2. Attainment of age-appropriate developmental milestones [ Time Frame: ASQ-3 score assessed 12 months after birth. ]
    Child Development Outcomes, measured by ASQ-3 (12-month survey)

  3. Attainment of age-appropriate developmental milestones [ Time Frame: ASQ-3 score assessed 6 months after birth. ]
    Child Development Outcomes, measured by ASQ-3 (6-month survey)


Secondary Outcome Measures :
  1. Attainment of age-appropriate developmental milestones [ Time Frame: ASQ-SE score assessed at 18 months after birth. ]
    Child Development Outcomes, measured by ASQ-Social Emotional (SE)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195036


Contacts
Contact: Joy N Baumgartner, PhD, MSSW (919) 681-6382 joy.baumgartner@duke.edu
Contact: Jennifer M Headley, MSW (919) 681-7288 jennifer.headley@duke.edu

Locations
Cameroon
Catholic Relief Services Recruiting
Yaoundé, Cameroon
Contact: Berenger Tchatchou, MA       berenger.tchatchou@crs.org   
Sponsors and Collaborators
Duke University
Catholic Relief Services
Investigators
Principal Investigator: Joy N Baumgartner, PhD, MSSW Duke University
More Information

Responsible Party: Joy Noel Baumgartner, Assistant Research Professor; Director, Evidence Lab, Duke University
ClinicalTrials.gov Identifier: NCT03195036     History of Changes
Other Study ID Numbers: D0989
2017/02/867/CE/CNERSH/SP ( Other Identifier: Comite National d'Ethique de la Recherche pour la Sante Hum. )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joy Noel Baumgartner, Duke University:
HIV-exposed
Early Childhood Development
Cameroon