Testing pregnant women in Kenya for sexually transmitted infections during prenatal care
Compares 3 ways of testing pregnant women for sexually transmitted infections.
Plain-language title generated from the registry record
Registry title: Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Key facts
- Where
- Homa Bay, Kisumu, and Yala, KenyaSee the 8 sites
Where in Kenya
- Homa Bay Teaching and Referral HospitalHoma Bay, KenyaTaking people
- Rachuonyo South Sub County HospitalHoma Bay, KenyaTaking people
- Rangwe Sub County HospitalHoma Bay, KenyaTaking people
- Chulaimbo County hospitalKisumu, KenyaTaking people
- Kisumu County HospitalKisumu, KenyaTaking people
- Lumumba Sub-County HospitalKisumu, KenyaTaking people
- Migosi Sub County HospitalKisumu, KenyaTaking people
- Yala sub County HospitalYala, KenyaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Washington
- Trial code
- NCT06203951
- Record updated
- 16 July 2025
- Original description
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.Read full original descriptionShow less
Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
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.
Inclusion: 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: Not willing to receive syndromic STI screening and HIV/syphilis testing per national guidelines; Male gender; Not seeking antenatal services from the clinic; Not planning to receive antenatal and postnatal care at the clinic; Not able or willing to provide informed consent for participation.