Clinical trial NCT05119959: Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving
Official title: Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Children exposed to HIV in-utero but uninfected (CHEUs)
Early childhood developmental (ECD) interventions
Community health workers
Home visits
Zambia
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2021-11-15
Enrollment: 469
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).


Eligibility criteria: Inclusion Criteria:

* 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.
* ZICS inclusion criteria were pregnant women (1:1, HIV+:HIV-) presenting for antenatal care at Chawama First Level Hospital and intending to deliver at Chawama First Level Hospital and less than 26 weeks gestation by ultrasound

Exclusion Criteria:

* Mother-infant dyads not enrolled in ZICS
* Mother-infant dyads where mother is \<18 years of age

Primary outcomes:
measure: Neurodevelopment at 18 months post enrollment
timeFrame: 18 months
Secondary outcomes:
measure: Neurodevelopment at 6 months post enrollment
timeFrame: 6 months
measure: Language development at 6, 12, and 18 months post enrollment
timeFrame: 6 months. 12 months, 18 months
measure: Child's age-specific tasks at 6, 12, and 18 months post enrollment
timeFrame: 6 months, 12 months, 18 months
measure: Caregiver mental health and wellbeing at 6, 12 and 18months post enrollment
timeFrame: 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Public Health
state: Massachusetts
city: Lusaka
country: Zambia
facility: Right to Care Zambia
state: Longacres
Study officials:
affiliation: BU School of Public Health
name: Julie M Herlihy, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Right to Care - Zambia
name: Ethan Zulu, MBChB MSc
role: PRINCIPAL_INVESTIGATOR
References: