Improving perinatal outcomes among Kenyan pregnant women affected by HIV with an integrated STI testing model - 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 addresses the combined high STI burden in pregnancy and high perinatal morbidity in HIV priority settings and is designed to provide crucial evidence to inform policy recommendations for STI testing in pregnancy in Kenya and other HIV high-burden settings.
