# A Novel Regimen to Prevent Malaria and STIs in Pregnant Women with HIV

> **NIH NIH K23** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2020 · $168,156

## Abstract

Project Summary/Abstract
Pregnant women with HIV in Africa have high rates of coinfection with malaria and sexually transmitted
infections (STIs) that contribute to adverse maternal and birth outcomes including stillbirth, preterm delivery,
low birth weight and vertical transmission of HIV. Malaria prophylaxis improves maternal and perinatal
outcomes but current regimens are limited by emerging resistance and serious interactions with medications
that are used in patients with HIV. The identification of a novel drug regimen with dual prevention for both
malaria and curable bacterial STIs in pregnancy would be an important innovation toward improved outcomes
in this vulnerable group of women and infants. To address this pressing problem, this K23 application
describes the background and experience of the applicant, Jodie A. Dionne-Odom, MD and her plan to acquire
the knowledge and training necessary to become an independent, leading scientist in the prevention and
treatment of coinfections in HIV-infected pregnant women in sub-Saharan Africa. Her K23 training objectives
are to: (1) develop expertise in the design and conduct of clinical trials in resource-limited settings (2) gain
advanced training in epidemiology and biostatistics including perinatal epidemiology, drug safety monitoring
and infection modeling techniques; (3) acquire skills in measuring malaria and STI endpoints and (4) gain
additional training in performing human subjects research and grant and manuscript preparation. To meet
these objectives, a comprehensive training plan has been developed in concert with an interdisciplinary team
of mentors and consultants who are established senior research experts. The plan includes hands-on learning,
coursework leading to an MSPH in Clinical and Translational Science and supplemental short courses and
conferences. Equipped with this training, Dr. Dionne-Odom will conduct research to test whether a novel
combination prophylactic regimen of trimethoprim-sulfamethoxazole (TMPS) and azithromycin (AZ) is superior
to the current standard malaria prophylaxis (TMPS) and whether it has the added benefit of reducing STI
prevalence. In Specific Aim 1, a phase II randomized controlled trial will be performed to test the efficacy of
the combination prophylaxis regimen TMPS-AZ compared to TMPS in HIV-infected pregnant women. The
primary efficacy outcome will be a decrease in the peripheral malaria parasite load at delivery. In Specific Aim
2, the prevalence of treatable bacterial STIs after 35 weeks gestation (or delivery) will be measured and
compared between both arms. In Specific Aim 3, the fetal/neonatal safety and adherence/tolerability of the
combination regimen will be determined. Data from this phase II trial will be used to support an R-01 phase III
multicenter randomized controlled trial in sub-Saharan Africa. The training acquired from this award in
combination with results from this project will facilitate the successful transition of Dr. Dio...

## Key facts

- **NIH application ID:** 9999349
- **Project number:** 5K23HD090993-05
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Jodie Ann Dionne
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $168,156
- **Award type:** 5
- **Project period:** 2016-09-23 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999349

## Citation

> US National Institutes of Health, RePORTER application 9999349, A Novel Regimen to Prevent Malaria and STIs in Pregnant Women with HIV (5K23HD090993-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9999349. Licensed CC0.

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