# Neurodevelopment In HEU Children Exposed In Utero To Dolutegravir Or Efavirenz

> **NIH NIH R01** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2022 · $585,353

## Abstract

PROJECT SUMMARY
The global population of HIV-uninfected children born following in utero exposure to HIV and ART has
grown to ~15 million, with more than 1 million HIV-exposed/uninfected (HEU) babies born each year.
With increased rates of early-childhood mortality and a range of medical morbidities, HEU children
comprise a vulnerable population. Of particular concern is the lack of neurodevelopmental and
social-emotional outcomes data following in utero exposure to some of the most commonly-
used maternal ARV regimens. Efavirenz (EFV) is one of the most widely-used ARVs worldwide,
including among women who are pregnant or may become pregnant. Many HIV programs are
currently rolling out dolutegravir (DTG) for use in first-line ART, despite the recent early signal for
neural tube defects with DTG from conception. However, no studies have evaluated whether in utero
exposure to DTG-based ART poses an independent threat to neurodevelopmental and/or social-
emotional outcomes in HEU children, and minimal data exist for EFV (or from older children). Our
aims are thus as follows: Aim 1: To assess and compare developmental outcomes
(neurodevelopment, psychosocial) at 2 years of age in HEU children exposed in utero to DTG-based
ARV vs. EFV-based ART; and to compare outcomes between HEU children in each of these ARV
exposure groups vs. HIV-unexposed toddlers. Aim 2: To undertake the same comparisons of ND
and social-emotional outcomes as in Aim 1, but at 5 years of age, and with additional targeted
assessment in these school-age children of domains that are more predictive of future functioning
(e.g., executive function). Aim 3: To assess (over time) and compare depression, anxiety, and sleep
problem scores in women taking DTG-based ART vs. EFV-based ART (and women living with HIV
vs. HIV-negative women).

## Key facts

- **NIH application ID:** 10404064
- **Project number:** 5R01MH121191-03
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Adam Robert Cassidy
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $585,353
- **Award type:** 5
- **Project period:** 2020-06-15 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10404064

## Citation

> US National Institutes of Health, RePORTER application 10404064, Neurodevelopment In HEU Children Exposed In Utero To Dolutegravir Or Efavirenz (5R01MH121191-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10404064. Licensed CC0.

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