Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Trial Parameters
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Brief Summary
The investigators will conduct a 3-arm individual-level RCT in Kisumu and Siaya, Kenya to compare perinatal outcomes associated with 3 models of STI testing and management in antenatal care. The investigators will enroll 3132 pregnant women and randomize 1:1:1 to receive standard-of-care (syndromic management only without CT, NG, or TV testing) vs. CT, NG, and TV testing using Xpert® assays universally vs. only among women without STI symptoms. All women with STIs detected and/or symptoms per Ministry of Health algorithms will receive immediate treatment, EPT per national guidelines, and tests of cure. All participants will be enrolled during routine antenatal care and followed through 9-months postpartum. The investigators will quantify and compare a composite outcome of pregnancy loss/stillbirth, PTB, LBW, SGA, and neonatal death, between randomization arms, in addition to several secondary and exploratory outcomes.
Eligibility Criteria
Inclusion Criteria: * Self-identifying as a cisgender woman * Seeking antenatal services from the clinic * Planning to receive antenatal and postnatal care at the clinic * Willingness to receive syndromic STI screening and HIV/syphilis testing per national guidelines * Able and willing to provide informed consent for participation Exclusion Criteria: * Male gender * Not seeking antenatal services from the clinic * Not planning to receive antenatal and postnatal care at the clinic * Not willing to receive syndromic STI screening and HIV/syphilis testing per national guidelines * Not able or willing to provide informed consent for participation