# Linking HIV Prevention and post-partum care: Safety, efficacy and feasibility of cabotegravir-LA PrEP in high-risk breastfeeding population in Botswana

> **NIH NIH R01** · BETH ISRAEL DEACONESS MEDICAL CENTER · 2021 · $668,126

## Abstract

Project Summary/Abstract: Preventing HIV among young women is key to ending the HIV
epidemic. However, prevention strategies have been hampered by poor adherence to oral pre-
exposure prophylaxis (PrEP) in women and difficult implementing PrEP for young healthy
women who have limited interaction with the healthcare system. The recent announcement that
injectable long-acting cabotegravir (CAB-LA) is associated with a 9-fold decrease in the
incidence of HIV infection in women compared with oral PrEP has the potential to transform the
course of the HIV epidemic if CAB-LA can be effectively implemented. In addition to identifying
strategies to efficiently reach young women at risk for HIV, breastfeeding safety data for CAB-
LA are needed to achieve widespread use in women. Countries with high HIV prevalence also
have high fertility and women spend up to 1/3 of their reproductive years pregnant and
breastfeeding. Additionally, HIV acquisition risk is 2-4 times higher during the post-partum
period, and preventing HIV during breastfeeding also prevents pediatric HIV infection. We
propose to address both implementation challenges and lack of breastfeeding safety data by
evaluating a strategy of starting CAB-LA PrEP in high risk women who are admitted to the post-
partum ward after delivery, and co-locating follow up PrEP services with post-partum and
pediatric care, in a primarily breastfeeding population in Botswana. The immediate post-partum
period is a unique time to reach young women with PrEP because they are engaged in regular
healthcare and highly motivated to stay healthy. In addition to assessing feasibility, uptake,
acceptability and retention of this approach, we will also measure HIV incidence with CAB-LA
PrEP in a real-world, high HIV prevalence setting. This will be the first large study to evaluate
the pharmacokinetics of CAB-LA in breastfeeding women without HIV (and their infants), and
this study will perform additional important safety evaluations related to use of integrase
inhibitors, including the impact of CAB on maternal weight and cardiometabolic outcomes, post-
partum depression and infant growth. We expect this innovative strategy will be easily scalable,
influence HIV prevention guidelines and result in the advancement of HIV prevention strategies
for women around the world.

## Key facts

- **NIH application ID:** 10403232
- **Project number:** 1R01HD108047-01
- **Recipient organization:** BETH ISRAEL DEACONESS MEDICAL CENTER
- **Principal Investigator:** Rebecca Marie Zash
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $668,126
- **Award type:** 1
- **Project period:** 2021-09-24 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10403232

## Citation

> US National Institutes of Health, RePORTER application 10403232, Linking HIV Prevention and post-partum care: Safety, efficacy and feasibility of cabotegravir-LA PrEP in high-risk breastfeeding population in Botswana (1R01HD108047-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10403232. Licensed CC0.

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