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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 6 Months and 24 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1- CHEU + ECD intervention 		Participants randomized to this arm will receive a bi-weekly community health worker-delivered ECD intervention for CHEUs
  • Other: ECD intervention for CHEUs
    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
Active Comparator
Arm 2- CHEU without ECD intervention 		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
    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.
Active Comparator
Arm 3- HIV Unexposed (HUU) without ECD intervention 		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
    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.

More Details

Status
Completed
Sponsor
Boston University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.