E.W. "Al" Thrasher
Status: Funded - Open
Julie Herlihy, MD, MPH
Summary
BACKGROUND: 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. GAP: Research is needed to evaluate the effectiveness of a scalable early childhood development (ECD) intervention for CHEUs. Zambia is scaling up ECD as part of its national strategy, but CHEUs are not currently targeted. There is need to better understand the scope and mechanism of HEU-related neurodevelopmental differences and what interventions are most effective. 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 2-3 years, mediated by preterm birth, disease stage or ARV exposure. METHODS: In order to observe differences in neurodevelopment between HIV-exposed and HIV-unexposed children, we will build upon an existing Zambian birth cohort by extending follow-up from 6 months to 2-3 years (n=450). Neurodevelopmental assessments will be measured by multiple context-validated tools at 6 (midline) and 18 months (endline) post enrollment. In addition, a randomized control trial of a bi-weekly community health worker-delivered ECD intervention for CHEUs will be conducted to assess its impact on CHEU neurodevelopment. RESULTS: Pending. IMPACT: Despite growing evidence, HIV-exposure is not currently prioritized as a risk factor for poor development by policy makers or ECD programs. By capitalizing on the wealth of prenatal and infant data collected in our ‘parent’ study, we can investigate the mechanism that links HEU to neurodevelopment and test a potential therapy. Addressing developmental vulnerability in CHEUs is paramount to ensuring that future generations of children are school ready, and able to reach their full developmental potential.