# Improving perinatal outcomes among Kenyan pregnant women affected by HIV with an integrated STI testing model

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2024 · $662,753

## Abstract

Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) infections in
pregnancy are associated with fetal loss, preterm birth (PTB), small-for-gestational age (SGA), infant mortality,
and other adverse outcomes. Approximately one in four pregnant women in East Africa have at least one of
these sexually transmitted infections (STIs) and prevalence is higher among women living with HIV (WLHIV). In
Kenya, syndromic STI management persists as standard of care (SOC) leading to untreated asymptomatic
infections and inappropriate antibiotic use. We found that only 34% of pregnant Kenyan women with STIs had
symptoms and NG in pregnancy was associated with 4-fold higher infant mortality. In response to this urgent
issue of public health importance, WHO and the US Preventive Services Task Force call for antenatal STI testing
models in HIV priority settings with robust cost-benefit data. The wide network of GeneXpert® machines at
decentralized laboratories at facilities in Kenya could be leveraged to provide molecular antenatal STI testing.
To optimize cost-benefit efficiency, one option is to treat women who are symptomatic and only test women
without STI symptoms. A second option is to provide universal STI testing regardless of symptom presentation,
which would provide more accurate diagnoses and guide appropriate antibiotic use. To date, no RCTs in HIV
priority settings compare different antenatal STI testing models that integrate the Xpert® platform within routine
antenatal care and no studies assess cost or implementation outcomes. In collaboration with the Kenya Ministry
of Health, we propose a randomized trial in Kisumu and Siaya–regions with 20% HIV prevalence among women
and 10% PTB rate–to compare models of STI testing in antenatal care. We will expand on our prior studies to
offer CT, NG, and TV testing using Xpert® assays in routine antenatal care, and prospectively ascertain perinatal
outcomes. This hybrid effectiveness-implementation RCT is designed to provide evidence to inform policy
decisions. We hypothesize that antenatal STI testing is a cost-effective strategy for improving perinatal outcomes
among women in HIV priority settings, a population disproportionately affected by STIs and perinatal morbidity.
Aim 1 will conduct a 3-arm RCT to compare SOC (syndromic management only) vs. CT, NG, and TV testing
using Xpert® assays universally vs. only among women without STI symptoms among antenatal care attendees
followed through 9 months postpartum. The primary outcome is a composite of fetal loss/stillbirth, PTB, SGA,
and neonatal death. Aim 2 will evaluate implementation outcomes of integrating STI testing into antenatal care
for pregnant women within public facilities guided by the Proctor framework (acceptability, appropriateness,
satisfaction, feasibility, and penetration). Aim 3 will estimate the costs and cost-effectiveness of implementing
different STI testing strategies in antenatal care. Our proposal add...

## Key facts

- **NIH application ID:** 10837516
- **Project number:** 1R01HD113455-01A1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** John Kinuthia
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $662,753
- **Award type:** 1
- **Project period:** 2024-02-07 → 2029-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10837516

## Citation

> US National Institutes of Health, RePORTER application 10837516, Improving perinatal outcomes among Kenyan pregnant women affected by HIV with an integrated STI testing model (1R01HD113455-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10837516. Licensed CC0.

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