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Study identifier: NCT06203951 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Hiv · Sexually Transmitted Infections (Not HIV or Hepatitis)  ·  Sponsor: University of Washington

PhaseNA
Planned participants3132
Who can joinFemale, N/A to no upper limit
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Lauren Gomez  ·  206-685-5044  ·  gomezL4@uw.edu

Felix Abuna  ·  +254 721 230652  ·  fabuna@uw.edu

Always discuss trial participation with your own doctor first.

Locations (8)

Homa Bay Teaching and Referral HospitalHoma Bay, KenyaRecruiting
Rachuonyo South Sub County HospitalHoma Bay, KenyaRecruiting
Rangwe Sub County HospitalHoma Bay, KenyaRecruiting
Chulaimbo County hospitalKisumu, KenyaRecruiting
Kisumu County HospitalKisumu, KenyaRecruiting
Lumumba Sub County hospitalKisumu, KenyaRecruiting
Migosi Sub County HospitalKisumu, KenyaRecruiting
Yala sub County HospitalYala, KenyaRecruiting

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Source record: clinicaltrials.gov/study/NCT06203951