Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Recruiting · NCT06203951 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
8 locations listed.
- 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