Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving (ZICS-BOOST)

Boston University

Status: Completed

Conditions: Child Development

Treatments: Other: Usual care for CHEUs; Other: ECD intervention for CHEUs

Study type: Interventional

Funder types: Other

Identifiers

NCT05119959

H-42282

Details and patient eligibility

About

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).

Enrollment: 469 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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469 participants in 3 patient groups

Arm 1- CHEU + ECD intervention

Experimental group

Description:

Participants randomized to this arm will receive a bi-weekly community health worker-delivered ECD intervention for CHEUs

Treatment:

Other: ECD intervention for CHEUs

Arm 2- CHEU without ECD intervention

Active Comparator group

Description:

Participants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment.

Treatment:

Other: Usual care for CHEUs

Arm 3- HIV Unexposed (HUU) without ECD intervention

Active Comparator group

Description:

Participants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment.

Treatment:

Other: Usual care for CHEUs