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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: Completed NA study, sponsored by Boston University.
NCT05119959 is a NA study that has completed, run by Boston University. The registered enrollment target is 469 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The Malawi Developmental Assessment Tool (MDAT) will be used to assess neurodevelopment. MDAT provides an independent evaluation of development in the domains of gross motor, fine motor, language and social skills. The MDAT can be administered in any environment as it requires minimal equipment and is more culturally relevant to our context. The scores from the MDAT are relatable and comparable to those obtained from the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III). Pri
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 |
What the finished NCT05119959 record still lists
NCT05119959 is an interventional study that assigns participants to a tested intervention. The registered 469 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which ECD intervention for CHEUs is the first listed.
NCT05119959 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05119959's enrollment target sits among peer trials
469 222nd of 2000 higher than 1,779 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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