Browsing by Author "Rockers, Peter C."

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    A Home-Based Nurturing Care Intervention for Children born HIV-Exposed but Uninfected in Zambia: A Randomized Clinical Trial
    Zulu, Ethan M.; Rockers, Peter C.; Forman, Leah; Musonda, Namwiya; Nthele, Charles; Shimaingwa, Frazer; Bartrum, Megan; Masempela, Carol B.; Thea, Donald M.; Herlihy, Julie M.
    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. Design 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. Method 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. Results 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). Conclusion 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.
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    Gut Microbiome and Environmental Enteric Dysfunction Are Unchanged by 18 Months of Small-Quantity Lipid-Based Nutrient Supplementation among Young Children in Lusaka, Zambia.
    (2026-Jun-22) Lauer, Jacqueline M.; Leng, Yaoan; Chembe, Mpela ; Henderson, Savanna; Parkerson, Doug; Chibesa, Kennedy; Moono, Andrew; Fink, Günther; Rockers, Peter C.; Locks, Lindsey M.
    Small-quantity lipid-based nutrient supplements (SQ-LNS) have been shown to improve growth, development, and survival among young children in low-resource settings. One hypothesized pathway is through improvements in intestinal health, including modulation of the gut microbiome and reductions in environmental enteric dysfunction (EED). This study examined the effects of SQ-LNS on the gut microbiome and markers of EED and systemic inflammation among young children in Lusaka, Zambia. We conducted intention-to-treat analyses of 302 children aged 27-35 months in a 2x2 cluster-randomized trial. Serum biomarkers of EED (soluble CD14, intestinal fatty acid binding protein) and inflammation (alpha-1-acid glycoprotein, C-reactive protein) were assessed in 240 children via the Multiple-Micronutrient and Environmental Enteric Dysfunction Assessment Tool (MEEDAT). Differences by SQ-LNS assignment were assessed using unadjusted and adjusted ordinary least squares regression models. Rectal swab samples from 299 children underwent 16S rRNA gene sequencing. Taxonomic profiles were visualized using stacked bar plots, alpha diversity was quantified using Shannon diversity indices, and beta diversity was assessed using non-metric multidimensional scaling based on Bray-Curtis dissimilarity matrices. We found that SQ-LNS had no significant effect on EED or inflammation biomarkers and was not associated with differences in gut microbiome alpha diversity, beta diversity, or overall microbial community composition. In exploratory analyses,