Comparison of Neurodevelopmental Outcomes Between HIV-Exposed, Uninfected and HIV- Unexposed Children The Tshipidi Study Presented by Jean Leidner J. Leidner 1,2, P. Williams 3, G. Mayondi 4, G. Ajibola 4, P. Holding 5, V. Tepper 6, S. Nichols 7, M. Diseko 4, J. Magetse 4, M. Sakoi 4, K. Moabi 4, J. Makhema 4, C. Mdluli 4, S. Chaudhury 8, C. Petlo 9, H. Jibril 9, B. Kammerer 10, S. Lockman 11 Affiliations: 1 Goodtables Data Consulting, Norman, OK, United States; 2 Harvard TH Chan School of Public Health, Harvard AIDS Institute, Boston, MA, United States; 3 Harvard TH Chan School of Public Health, Dept. of Biostatistics, Boston, MA, United States; 4 Botswana Harvard AIDS Institute Partnership for Research and Education, Gaborone, Botswana; 5 Independent Consultant, Boston, MA, United States; 6 University of Maryland School of Medicine, Dept. of Pediatrics, Baltimore, MD, United States; 7 University of California, San Diego, Dept. of Neurosciences, San Diego, CA, United States; 8 Harvard TH Chan School of Public Health, Dept. of Epidemiology, Boston, MA, United States; 9 Ministry of Health Botswana, Gaborone, Botswana, 10 Boston Children’s Hospital, Dept. of Psychiatry, Boston, MA, United States; 11 Brigham and Women’s Hospital, Boston, MA, United States

Selected baseline factors, HIV-exposed and HIV-unexposed children and their mothers Background CharacteristicHIV-exposed* (n=337) HIV-unexposed (n=387) P-value Maternal Mean age at enrollment (years) <0.001 No/primary education only50 (15%)20 (5%)<0.001 No personal earnings213 (63%)290 (75%)<0.001 Electricity in home164 (49%)248 (64%)<0.001 Moderate/severe food insecurity179 (53%)128 (33%)<0.001 Mean depression score (0-20)2.82.1<0.001 Infant Breastfed28 (8%)384 (99%)<0.001 Low birthweight (<2.5kg)56 (17%)32 (8%)<0.001 Prospectively followed HIV-infected and –uninfected mothers and their children from pregnancy 24 months postpartum at 2 sites in Botswana (from ) Compared neurodevelopmental (ND) outcomes between 337 HIV-exposed/uninfected and 387 HIV-unexposed children tested at 24 months (range months) using adapted Bayley-III (5 domains) + Developmental Milestones Checklist * HIV-infected women took antenatal ZDV (64%), 3-drug ART (35%, majority using CBV+NVP ), or no ARVs (<1%)

Bayley-III Developmental Milestones Checklist Comparison of Adjusted Neurodevelopmental Scores by HIV Exposure Note: No adjustments were made for feeding method due to collinearity with maternal HIV status. Formula-feeding by HIV-infected mothers would expect to bias toward lower ND scores in HIV- exposed children

Conclusions HIV-exposed/uninfected children in Botswana scored as well as HIV-unexposed children at 24 months of age, on multiple measures of neurodevelopment (in both unadjusted and adjusted analyses) Provides reassurance regarding the potential effects of in utero HIV- and antiretroviral exposure Additional data among older children and following exposure to newer antiretrovirals are warranted This study was funded by NIMH (RO1MH ). We are grateful to the participants and the excellent study team in Botswana Abstract #: THPDB0101