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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24months for reporting.

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 more

ZICS-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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor

454 Previous Clinical Trials

9,941,045 Total Patients Enrolled

Thrasher Research FundOTHER

132 Previous Clinical Trials

93,849 Total Patients Enrolled

Julie M Herlihy, MD MPHPrincipal InvestigatorBU School of Public Health

1 Previous Clinical Trials

1,009 Total Patients Enrolled

Media Library

ECD intervention for CHEUs Clinical Trial Eligibility Overview. Trial Name: NCT05119959 — N/A

Child Development Research Study Groups: Arm 2- CHEU without ECD intervention, Arm 1- CHEU + ECD intervention, Arm 3- HIV Unexposed (HUU) without ECD intervention

Child Development Clinical Trial 2023: ECD intervention for CHEUs Highlights & Side Effects. Trial Name: NCT05119959 — N/A

ECD intervention for CHEUs 2023 Treatment Timeline for Medical Study. Trial Name: NCT05119959 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots remaining for this experiment?

"The details of this study, which were first posted on April 14th 2022, have not been updated since May 2nd. Consequently, no more candidates are being recruited for the trial at present. However, there are currently 59 different clinical trials actively seeking participants across the United States."

Answered by AI

Is it permissible for individuals over the age of 30 to participate in this research?

"This research requires that participants are between 6 months and 9 months of age. Additionally, there is a separate trial for those under 18 years old (47 in total) as well as another one for anyone over 65 (21 trials)."

Answered by AI

To whom is this clinical trial open for enrollment?

"This research study is aiming to recruit 525 participants between the ages of 6 and 9 months. To be considered for participation, applicants must have joined Zambia Infant Cohort Study (ZICS) prior to 18 years old, or if their infant qualifies within this age range by February 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving

2022. "Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119959.