# Closing Research Gaps in Antiretroviral Treatment for Pregnant Women and Infants Living with HIV

> **NIH NIH P01** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2024 · $1,195,048

## Abstract

Overall Project Summary/Abstract
Antiretroviral treatment (ART) options for pregnant women and children living with HIV have fallen behind those
for adults, reflecting the substantial research gap for modern ART regimens in these groups. Safety and efficacy
studies of specific ART regimens in pregnancy, and strategies for starting modern ART in early infancy, have
become research priorities. Here we propose a series of interrelated projects that expand the scientific objectives
and data utilization of a valuable NIH-funded nationwide birth surveillance system in Botswana (the Tsepamo
Study), and connect it with the infrastructure provided by an existing program for identifying and treating infants
with HIV (the Early Infant Treatment Study, or EIT). The four proposed projects, anchored by administrative and
data cores, include:
1) Tsepamo Plus: Expanded Congenital Abnormalities Surveillance and an Emulated Clinical Trial to
Evaluate Weight Impact on Birth Outcomes for Newer ART Regimens: an expanded surveillance program
for neural tube defects and other congenital abnormalities following exposure to modern ART regimens, and an
emulated clinical trial to address critical questions related to use of ART regimens by maternal weight strata.
2) Methodology: Developing Reporting Criteria for Pregnancy Surveillance Cohorts and New Techniques
for Supporting Target Trials: the creation of surveillance reporting criteria in pregnancy cohorts and validation
of a target trial approach to ART regimen comparisons.
3) Point-of-Care HIV Testing and Early Dolutegravir Use for Infants: a new approach to targeted facility-
based point-of-care HIV testing, combined with an optimized ART management strategy that uses dolutegravir
from early infancy.
4) Pioneering Precision Medicine Approaches for Immune Control of Pediatric HIV-1 Infection: utilizing
shared data and infrastructure to efficiently obtain specimens, this project will bank HIV sequences from early-
treated infants, measure and compare viral reservoir and chromosomal positioning between ART regimens, and
study immune responses to mRNA vaccines among children with HIV to begin development of an mRNA HIV
vaccine program for children in Botswana.
This P01 brings together a group of experienced investigators who will forge a cohesive research program using
the unique data sources and outstanding physical infrastructure available from the Tsepamo and EIT research
programs in Botswana. Each project addresses key scientific issues related to ART use during pregnancy and
initiation of ART in early infancy, and together they will efficiently close research gaps for women and children
with HIV.

## Key facts

- **NIH application ID:** 10914846
- **Project number:** 5P01HD107670-04
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Roger L Shapiro
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,195,048
- **Award type:** 5
- **Project period:** 2021-09-24 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10914846

## Citation

> US National Institutes of Health, RePORTER application 10914846, Closing Research Gaps in Antiretroviral Treatment for Pregnant Women and Infants Living with HIV (5P01HD107670-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10914846. Licensed CC0.

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