# Clinical Study of STI Screening to Prevent Adverse Birth and Newborn Outcomes

> **NIH NIH R01** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2022 · $951,169

## Abstract

ABSTRACT
Infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) during
pregnancy are associated with premature rupture of membranes, preterm labor and delivery, low birth weight,
congenital infections, perinatal death and mother-to-child transmission of HIV infection. Sexually transmitted
infections (STIs) like these are common in pregnant women globally, but often go undiagnosed; recent work by
our group found a 41% STI prevalence amongst HIV-infected pregnant women, of which 64% of infections were
asymptomatic. Recent research suggests the vaginal microbiome may play a critical role in STI acquisition,
persistence and treatment outcomes. Our pilot work has shown that diagnostic testing for CT, NG, and TV in
antenatal care services for HIV-infected pregnant women in South Africa is highly acceptable and feasible;
however, our work has made clear that evaluating the impact and cost effectiveness of different diagnostic
screening strategies that optimally decrease the burden of STIs during pregnancy and at time-of-delivery is
urgently needed. Furthermore, our findings highlight that biological factors that increase the risk for STI
persistence and/or treatment failures must be further investigated.
In response to the need to 1) identify optimal, cost-effective screening strategies that decrease the burden of
STIs during pregnancy and reduce adverse birth outcomes, 2) provide evidence to update WHO's syndromic
management guidelines, and 3) elucidate the role of the vaginal microbiome in STI treatment outcomes, we
propose a novel, highly innovative study with the following three Aims:
Aim 1: Evaluate 3 different screening strategies to decrease the burden of CT/NG/TV among pregnant
 women, and reduce adverse birth outcomes.
Aim 2: Evaluate cost per pregnant woman screened and treated, cost of adverse birth outcomes, and
 cost-effectiveness per STI and disability-adjusted life-year (DALY) averted.
Aim 3: Investigate the relationship between the vaginal microbiome and persistent Chlamydial
 infections in pregnant women.
Our proposed 5-year study will enroll 1250 HIV-infected and 1250 uninfected pregnant women from three large
ANC clinics in Tshwane District, South Africa, as well as their ~2500 neonates and up to 834 male partners. Our
research team, led by established researchers, has significant expertise and experience in all aspects of the
proposed study. Our multi-institutional collaborations will allow us to leverage unique implementation platforms
and resources, and allow for rapid dissemination of findings to South African and global stakeholders.

## Key facts

- **NIH application ID:** 10322132
- **Project number:** 5R01AI149339-04
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** Jeffrey David Klausner
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $951,169
- **Award type:** 5
- **Project period:** 2020-01-07 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10322132

## Citation

> US National Institutes of Health, RePORTER application 10322132, Clinical Study of STI Screening to Prevent Adverse Birth and Newborn Outcomes (5R01AI149339-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10322132. Licensed CC0.

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