Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving

NCT05119959 | Completed

• 1 other identifier: H-42282
• Study Type: interventional
• Target: 469
• Locations: 2 countries
• Sites: 2

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).

Conditions

Child Development

Keywords

Children exposed to HIV in-utero but uninfected (CHEUs); Early childhood developmental (ECD) interventions; Community health workers; Home visits; Zambia

Outcome Measures

Primary Outcomes (1)

• Neurodevelopment at 18 months post enrollment

  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). Primary outcomes will be z-scores from four neurodevelopmental domain measurements-gross motor, fine motor, language, and social.

  18 months

Secondary Outcomes (4)

• Neurodevelopment at 6 months post enrollment

  6 months

• Language development at 6, 12, and 18 months post enrollment

  6 months. 12 months, 18 months

• Child's age-specific tasks at 6, 12, and 18 months post enrollment

  6 months, 12 months, 18 months

• Caregiver mental health and wellbeing at 6, 12 and 18months post enrollment

  6 months, 12 months, 18 months

Study Arms (3)

Arm 1- CHEU + ECD intervention

EXPERIMENTAL

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

Other: ECD intervention for CHEUs

Arm 2- CHEU without ECD intervention

ACTIVE COMPARATOR

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

Other: Usual care for CHEUs

Arm 3- HIV Unexposed (HUU) without ECD intervention

ACTIVE COMPARATOR

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

Other: Usual care for CHEUs

Interventions

ECD intervention for CHEUs OTHER

The bi-weekly community health worker-delivered ECD 1 hour intervention using the modules from the SUPERCDZ curriculum which is a Zambian adaptation of UNICEF's Nurturing Care Framework

Arm 1- CHEU + ECD intervention

Usual care for CHEUs OTHER

No ECD interventions will be provided by community health workers. Children will be followed at clinics for growth and monitoring, vaccinations on a MoH approved schedule.

Arm 2- CHEU without ECD intervention; Arm 3- HIV Unexposed (HUU) without ECD intervention

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead
• Thrasher Research Fund: collaborator

Study Sites (2)

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

Right to Care Zambia

Lusaka, Longacres, Zambia

Location

Study Officials

• Julie M Herlihy, MD MPH

  BU School of Public Health

  PRINCIPAL INVESTIGATOR

• Ethan Zulu, MBChB MSc

  Right to Care - Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: April 14, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ZA (1)