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Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Sponsor: University of Washington
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.
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
3132
Start Date
2025-01-27
Completion Date
2028-12-31
Last Updated
2025-07-16
Healthy Volunteers
Yes
Interventions
Xpert® CT/NG and TV testing
Participants randomized to universal STI testing will be offered Xpert® CT/NG and TV testing regardless of symptoms, and they will receive a standard syndromic STI assessment. Participants randomized to the asymptomatic only testing will be offered Xpert® CT/NG and TV testing if no signs or symptoms of CT, NG, or TV are identified during STI assessment. Participants assigned to receive Xpert® testing will be counseled on CT/NG/TV testing, including the benefits of testing even in the absence of symptoms to detect asymptomatic infections (as informed by pilot evaluation). If a client accepts Xpert® testing, she will be instructed by the study nurse on how to self-collect a vaginal swab.
Locations (8)
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