A Home-Based Nurturing Care Intervention for Children born HIV-Exposed but Uninfected in Zambia: A Randomized Clinical Trial

Abstract

<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Introduction</jats:title> <jats:p>Research demonstrates neurodevelopmental differences in children who are HIV-exposed, but uninfected (CHEU) compared to their peers born unexposed. CHEUs are at higher risk for prematurity and low birth weight, both known risk factors for developmental delays. Despite increasing evidence, HIV exposure remains underrecognised as a risk factor for poor development by policy-makers and early childhood development (ECD) programs. We trialed an ECD intervention for CHEUs based on the Nurturing Care Framework developed by WHO, UNICEF, and the World Bank to improve neurodevelopmental outcomes in this vulnerable population.</jats:p> </jats:sec> <jats:sec> <jats:title>Design</jats:title> <jats:p>We conducted a randomized controlled trial of an ECD intervention for mothers living with HIV and their children born HIV-exposed, aged six to 24 months, living in peri-urban Lusaka. The intervention was delivered through bi-weekly home visits over 18 months using the curriculum adapted from the Nurturing Care Framework. The curriculum addressed nutrition, maternal wellness, child health, developmental milestones, and interactive caregiving.</jats:p> </jats:sec> <jats:sec> <jats:title>Method</jats:title> <jats:p>The primary outcome was measured by the Malawi Developmental Assessment Tool (MDAT) at six and 18 months post enrollment, which assesses developmental scores via a context-validated, direct observation tool across four domains: gross motor, fine motor, language, and social development. Participants were also assessed at six, 12 and 18 months post enrollment using the Caregiver Reported Early Development Instrument (CREDI). MDAT assessors were blinded to the intervention and control arm.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>We enrolled 308 mother-infant pairs, randomized 1:1 into an ECD intervention (CHEU control, n = 155; CHEU intervention, n = 153). At six months post enrollment, the intervention was associated with modest improvements in two developmental domains, particularly cognitive (Adjusted 0.28, 95% CI: 0.09 to 0.46; p= 0.004) and social-emotional development (Adjusted 0.29, 95% CI: 0.08 to 0.49; p= 0.07). At 18 month post enrollment, adjusted models demonstrated a moderate positive effect with gross motor development, with participants showing a 0.24 standard deviation higher score compared with the control group (95% CI: 0.02–0.46; p=0.034).</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>The findings indicate that the intervention may have a moderate impact on cognitive and social-emotional outcomes after six months, as well as on gross motor functions after eighteen months of intervention.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration</jats:title> <jats:p> <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://Clinicaltrials.gov">Clinicaltrials.gov</jats:ext-link> <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT05119959">NCT05119959</jats:ext-link> </jats:p> </jats:sec>