Actively Recruiting
Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Led by University of Washington · Updated on 2025-07-16
3132
Participants Needed
8
Research Sites
204 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Homa Bay Teaching and Referral Hospital
Homa Bay, Kenya
Actively Recruiting
2
Rachuonyo South Sub County Hospital
Homa Bay, Kenya
Actively Recruiting
3
Rangwe Sub County Hospital
Homa Bay, Kenya
Actively Recruiting
4
Chulaimbo County hospital
Kisumu, Kenya
Actively Recruiting
5
Kisumu County Hospital
Kisumu, Kenya
Actively Recruiting
6
Lumumba Sub County hospital
Kisumu, Kenya
Actively Recruiting
7
Migosi Sub County Hospital
Kisumu, Kenya
Actively Recruiting
8
Yala sub County Hospital
Yala, Kenya
Actively Recruiting
Research Team
L
Lauren Gomez
CONTACT
F
Felix Abuna
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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