Study to Improve Pregnancy Outcomes in Kenyan Women Using Three Different STI Testing Approaches During Antenatal Care

What this Trial Is About

Researchers are evaluating three different approaches to testing and managing sexually transmitted infections STIs during pregnancy in Kisumu and Siaya, Kenya. The study aims to compare the effects of these approaches on perinatal outcomes such as pregnancy loss, preterm birth, low birth weight, small size for gestational age, and neonatal death. This randomized controlled trial will involve 3,132 pregnant women receiving antenatal care at selected clinics, with follow-up extending through nine months after delivery. Participants will be randomly assigned to one of three groups standard care involving symptom-based STI management without specific testing for Chlamydia trachomatis CT, Neisseria gonorrhoeae NG, or Trichomonas vaginalis TV universal Xpert4 STI testing regardless of symptoms or Xpert4 testing only for women without STI symptoms. All women diagnosed with STIs or showing symptoms will receive treatment, including expedited partner therapy and tests to confirm cure, following national guidelines. Testing uses a self-collected vaginal swab and is integrated into routine antenatal visits. During the study, participants will undergo regular STI assessments, treatment monitoring, and follow-up visits up to nine months postpartum. Researchers will collect detailed information on demographics, sexual and clinical history, and behavioral factors. Outcomes will be measured at six weeks and nine months postpartum, including STI prevalence, HIV incidence, and quality of care indicators. Participant safety and treatment adherence will be supported with study nurse contact and data monitoring throughout the trial.

Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model