Yala

Researchers are conducting a randomized controlled trial in Kisumu and Siaya, Kenya, to compare perinatal outcomes among pregnant women receiving three different approaches to testing and managing sexually transmitted infections (STIs) during antenatal care. The study will enroll 3,132 pregnant women and evaluate outcomes such as pregnancy loss, stillbirth, preterm birth, low birth weight, small for gestational age, and neonatal death. This trial aims to inform policy decisions by including a representative sample of antenatal clients regardless of age, HIV status, or gestational age at enrollment. Participants will be randomly assigned to one of three groups: standard care with syndromic management only, universal STI testing using Xpert4 assays for chlamydia, gonorrhea, and trichomonas, or STI testing only among women without symptoms. Women with detected STIs or symptoms will receive immediate treatment, expedited partner therapy according to national guidelines, and tests of cure. Enrollment occurs during routine antenatal visits, with follow-up continuing through nine months postpartum. During the study, participants will complete demographic, behavioral, and clinical assessments, including sexual history and pregnancy history. Study nurses will collect vaginal swabs for testing when applicable, and participants will receive counseling on STI testing benefits. Researchers will monitor health outcomes up to six weeks postpartum, focusing on perinatal results and safety. The trial includes ongoing data monitoring to ensure unbiased outcome assessment.