Improving health outcomes for pregnant women in Kenya through STI testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of three different models of STI testing and management during antenatal care for pregnant women in Kisumu and Siaya, Kenya. A total of 3,132 participants will be randomly assigned to receive either standard-of-care management or enhanced STI testing using Xpert® assays, with follow-up through nine months postpartum. The study will assess various perinatal outcomes, including pregnancy loss, preterm birth, low birth weight, and neonatal death, to determine which testing model yields the best results for maternal and infant health.

Why it matters

Who can join: the full rules

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

Where it's running

• Homa Bay Teaching and Referral Hospital
  Homa Bay, Kenya Recruiting
• Rachuonyo South Sub County Hospital
  Homa Bay, Kenya Recruiting
• Rangwe Sub County Hospital
  Homa Bay, Kenya Recruiting
• Chulaimbo County hospital
  Kisumu, Kenya Recruiting
• Kisumu County Hospital
  Kisumu, Kenya Recruiting
• Lumumba Sub County hospital
  Kisumu, Kenya Recruiting

Study contacts

• Principal investigator: Jillian Pintye, RN, MPH, PHD — University of Washington
• Study coordinator: Lauren Gomez
• Email: gomezL4@uw.edu
• Phone: 206-685-5044

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.