Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05119959 · ClinicalTrials.gov registry record · NA
Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving
A NA study, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 469
- Enrollment target
NCT05119959 is a NA study that has completed, run by Boston University. The registered enrollment target is 469 participants.
The verdict
NCT05119959, a NA study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 469 participants
- Enrollment target
Study Summary
Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted. There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months. In this RCT the investigators will test the following hypotheses: Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs. Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure. This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHE
Interventions
- OTHER ECD intervention for CHEUs
- OTHER Usual care for CHEUs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 469 participants |
| Start Date | 2022-04-14 |
| Est. Completion | 2024-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05119959
The ClinicalTrials.gov registry entry for NCT05119959 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 469 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ECD intervention for CHEUs is the first listed.
NCT05119959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05119959 about?
NCT05119959 is a clinical study titled "Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving". Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. I...
What is the current status of trial NCT05119959?
This trial is currently completed. It is a NA study. The enrollment target is 469 participants. The study started on 2022-04-14. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT05119959?
The interventions under investigation include: ECD intervention for CHEUs (OTHER), Usual care for CHEUs (OTHER).
Who is sponsoring clinical trial NCT05119959?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.