# Botswana Birth Outcomes Surveillance Extension

> **NIH NIH R01** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2020 · $190,561

## Abstract

Abstract
Antiretroviral treatment (ART) guidelines depend upon safety data in pregnancy. Although developed countries
have moved to dolutegravir (DTG)-based first-line ART for non-pregnant adults, the World Health Organization
(WHO) still recommends efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) while awaiting safety data for
DTG that may harmonize guidelines for pregnant and non-pregnant adults. In June 2016, Botswana became
the first country in Africa to switch to DTG/TDF/FTC as first-line ART for adults, including pregnant women.
This change occurred in the setting of ongoing NIH-supported birth outcomes surveillance at 8 sites throughout
Botswana (R01HD080471), which was designed to evaluate adverse birth outcomes by ART regimen and
neural tube defects by EFV exposure status. This surveillance system has already provided initial safety data
for the DTG roll-out, and has raised concerns about the safety of specific nevirapine- and lopinavir/ritonavir-
based “legacy” ART regimens in pregnancy. Botswana's change to DTG/TDF/FTC, combined with the
government's plan to switch women off “legacy” ART starting in 2018, opens new scientific opportunities for
this surveillance system. We are therefore applying for a new R01 to continue (and enhance) birth outcomes
surveillance in Botswana. Our proposal has the following primary aims: 1) to perform the first large analysis of
adverse birth outcomes and congenital abnormalities following DTG exposure from the time of conception, and
2) to evaluate birth outcomes among women who either continue “legacy” ART or switch to DTG/TDF/FTC
prior to (or during) pregnancy. These novel aims take advantage of the unique ART landscape in Botswana
(including an upcoming plan to switch women off legacy ART regimens), and build on the emerging scientific
findings from our highly productive surveillance system. Data generated from this study will be critical for
updating WHO (and US) guidelines for the use of ART among pregnant women, and for women who may
become pregnant.

## Key facts

- **NIH application ID:** 10001130
- **Project number:** 3R01HD095766-02S1
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Roger L Shapiro
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $190,561
- **Award type:** 3
- **Project period:** 2018-08-03 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10001130

## Citation

> US National Institutes of Health, RePORTER application 10001130, Botswana Birth Outcomes Surveillance Extension (3R01HD095766-02S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10001130. Licensed CC0.

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