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

RecruitingNAAges any - anyFemaleUniversity of Washington
NCT06203951 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 seco

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📋 Eligibility rules (as published)
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
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What it tests

  • Xpert® CT/NG and TV testing
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Where

8 sites
Homa Bay Teaching and Referral Hospital
Homa Bay, Kenya
Rachuonyo South Sub County Hospital
Homa Bay, Kenya
Rangwe Sub County Hospital
Homa Bay, Kenya
Chulaimbo County hospital
Kisumu, Kenya
Kisumu County Hospital
Kisumu, Kenya
Lumumba Sub County hospital
Kisumu, Kenya
Migosi Sub County Hospital
Kisumu, Kenya
Yala sub County Hospital
Yala, Kenya
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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