Background
Data on child development following in utero antiretroviral (ARV) exposure suggest increased risk of delay in language skills, although most studies to date are among women living with HIV and their infants who have exposure to both ARVs and HIV. We assessed the relationship between prenatal PrEP exposure and language development at 60 months among mother-child pairs without HIV.
Methods
Data from mother-child pairs enrolled in a cluster RCT (NCT03070600) evaluating PrEP delivery strategies at 20 antenatal clinics in Western Kenya were analyzed. HIV-negative women were enrolled and offered oral tenofovir disoproxil fumarate-based PrEP during pregnancy and followed through 9 months postpartum regardless of PrEP status. A subset were enrolled into an extension cohort at 4 sites to be followed until their children reached 5 years. Language development was assessed by trained nurses using the validated Malawi Developmental Assessment Tool. The association between prenatal PrEP exposure and language development scores at 60 months was evaluated using linear regression models adjusted for gestational age at birth, maternal age and education, infant sex, and partner HIV status. We also evaluated the association between language development scores and timing of PrEP initiation (<14 weeks, 14-27 weeks, and >=27 weeks gestation) and duration on PrEP during pregnancy (<4 weeks, 4-12 weeks, and >12 weeks).
Results
As of January 2025, 768 children had reached 60 months and were included in the analysis; 139 (18%) had any in-utero PrEP exposure with a median duration of 2.4 months (IQR: 1.4-3.5) during pregnancy. Compared to mothers who did not take PrEP, mothers who took PrEP in pregnancy were more likely to only have primary school education (69% vs. 55% p=0.004) and to have a partner known to be living with HIV or of unknown status (68% vs 38% p<0.001). Mean language development scores at 60 months were 36.8 (SD: 1.6) among exposed and 37.1 (SD: 1.6) among unexposed. There was no difference in mean language scores at 60 months (adjusted mean differences: language -0.12, 95% CI: -0.45, 0.20, p=0.47). Language development scores were similar when analyzed separately by timing of PrEP initiation and weeks of duration on PrEP in pregnancy (all p>0.05).
Conclusions
Our results add to the limited data on language development in ARV-exposed children who are not exposed to HIV and suggest that exposure to ARVs without HIV exposure is not associated with adverse language development outcomes.