# A Randomized Trial of 17-Hydroxyprogesterone Caproate (17P) to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $522,897

## Abstract

ABSTRACT
A Trial of 17-Hydroxyprogesterone Caproate (17P) to Reduce Preterm Birth Among Women Receiving
Antiretroviral Therapy in Pregnancy
Preterm birth (PTB) is the most common cause of neonatal death worldwide and the second leading cause of
under-5 mortality. Maternal HIV complicates 1.5 million pregnancies per year and increases the risk of PTB.
While antiretroviral therapy (ART) in pregnancy can virtually eliminate mother-to-child transmission, it
increases the risk of PTB beyond the excess risk attributable to HIV itself. This has led us to the untenable
place where, in too many instances, the price of stopping perinatal HIV is prematurity-related neonatal
death.
Prenatal progesterone reduces the risk of PTB among women diagnosed with shortening of the uterine cervix
and among women who have experienced a prior spontaneous PTB. It is standard of care for these indications
in the United States.
This application has two specific aims. In Aim 1, we propose a placebo-controlled, double-masked randomized
clinical trial of the drug 17-hydroxyprogesterone (17P) to prevent PTB among HIV-infected pregnant women
initiating or continuing antiretroviral drug therapy (ART) in Malawi and Zambia. Because stillbirth and preterm
birth are competing risks, the trial's primary outcome will be a composite of live birth prior to 37 weeks
gestation or stillbirth at any gestational age. The trial is powered to assess whether 17P has the same
prophylactic efficacy among HIV-infected women as it does among women with a prior PTB (an indication for
which it is FDA approved). Our specific hypothesis is that 17P will reduce the primary outcome by 38% (i.e.,
from 24% to 15%). The trial will randomly allocate 800 consenting women in a 1:1 ratio to receive weekly
intramuscular injections of either active drug or matched placebo. We will follow women through pregnancy
and mother-infant pairs to 42 days postpartum. In Aim 2 of this application, we will study the relationship
between timing of ART initiation and the risk of PTB. Our hypothesis is that HIV-infected women who start ART
during pregnancy will have higher rates of PTB compared to women who enter antenatal care on ART started
prior to conception.
This trial will take advantage of longstanding partnerships and robust research infrastructure in Malawi and
Zambia. If our primary hypothesis is confirmed – that 17P works as well among HIV infected women as it does
among those with a prior preterm birth – we will have identified an intervention that could prevent as many as
70,000 preterm births per year worldwide.

## Key facts

- **NIH application ID:** 9996740
- **Project number:** 5R01HD087119-05
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** JEFFREY Samuel Allen STRINGER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $522,897
- **Award type:** 5
- **Project period:** 2016-09-27 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9996740

## Citation

> US National Institutes of Health, RePORTER application 9996740, A Randomized Trial of 17-Hydroxyprogesterone Caproate (17P) to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy (5R01HD087119-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9996740. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*