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ECD Intervention for Child Development (ZICS-BOOST Trial)
N/A
Waitlist Available
Led By Julie M Herlihy, MD MPH
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Zambia Infant Cohort Study (ZICS) cohort participants who are >18 years old AND are still pregnant OR whose infants are less than 9 months of age by February 2022.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24months
Awards & highlights
ZICS-BOOST Trial Summary
This trial will test whether a scalable early childhood development intervention delivered by community health workers via bi-weekly home visits improves neurodevelopmental outcomes in children exposed to HIV in-utero but uninfected (CHEUs).
Who is the study for?
This trial is for children in Zambia who were exposed to HIV before birth but are uninfected (CHEUs). They must be part of the ZICS cohort, with mothers over 18 years old and still pregnant or have infants under 9 months as of February 2022. Those not enrolled in ZICS or with infants older than 9 months by that date cannot join.Check my eligibility
What is being tested?
The study tests if a home-based early childhood development (ECD) program improves neurodevelopment at age two in CHEUs. It's a randomized trial comparing three groups: CHEUs receiving ECD intervention, CHEUs without it, and HIV-unexposed peers without intervention.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, there are no direct physical side effects expected from participating. However, the impact on child development will be closely monitored.
ZICS-BOOST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, part of the ZICS, and either still pregnant or my baby is under 9 months as of February 2022.
ZICS-BOOST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurodevelopment at 24 months
Secondary outcome measures
Caregiver mental health and wellbeing at 12 months
Caregiver mental health and wellbeing at 18 months
Caregiver mental health and wellbeing at 24 months
+10 moreZICS-BOOST Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1- CHEU + ECD interventionExperimental Treatment1 Intervention
Participants randomized to this arm will receive a bi-weekly community health worker-delivered ECD intervention for CHEUs
Group II: Arm 2- CHEU without ECD interventionActive Control1 Intervention
Participants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment.
Group III: Arm 3- HIV Unexposed (HUU) without ECD interventionActive Control1 Intervention
Participants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment.
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Who is running the clinical trial?
Boston UniversityLead Sponsor
458 Previous Clinical Trials
9,945,858 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
93,899 Total Patients Enrolled
Julie M Herlihy, MD MPHPrincipal InvestigatorBU School of Public Health
1 Previous Clinical Trials
1,009 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, part of the ZICS, and either still pregnant or my baby is under 9 months as of February 2022.I am a mother younger than 18 years old.I am pregnant, planning to deliver at Chawama Hospital, and less than 24 weeks along.My baby and I are not part of ZICS or my ZICS baby is over 9 months old as of February 1, 2022.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2- CHEU without ECD intervention
- Group 2: Arm 1- CHEU + ECD intervention
- Group 3: Arm 3- HIV Unexposed (HUU) without ECD intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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